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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05551117
Registration number
NCT05551117
Ethics application status
Date submitted
19/09/2022
Date registered
22/09/2022
Date last updated
10/05/2024
Titles & IDs
Public title
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
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Scientific title
A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
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Secondary ID [1]
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CP-MGC018-03
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Universal Trial Number (UTN)
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Trial acronym
Tamarack
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Castration-Resistant Prostatic Cancer
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Androgen-Independent Prostatic Cancer
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Androgen-Insensitive Prostatic Cancer
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Androgen-Resistant Prostatic Cancer
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Hormone Refractory Prostatic Cancer
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Anal Cancer
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Anal Neoplasm
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Carcinoma, Squamous Cell of Head and Neck
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Head and Neck Squamous Cell Carcinoma
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Laryngeal Squamous Cell Carcinoma
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Oral Squamous Cell Carcinoma
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Malignant Melanoma
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Melanoma
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Non-small Cell Lung Cancer
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Non-small Cell Carcinoma
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Small-cell Lung Cancer
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Small Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Cancer
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Prostate
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Cancer
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Malignant melanoma
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Cancer
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Head and neck
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Cancer
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Bowel - Anal
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - vobramitamab duocarmazine 2.0 mg (Arm A)
Other interventions - vobramitamab duocarmazine 2.7 mg (Arm B)
Other interventions - vobramitamab duocarmazine
Experimental: Part 1: MGC018 2.0 mg (Arm A) - MGC018 2.0 mg/kg every 4 weeks
Experimental: Part 1: MGC018 2.7 mg (Arm B) - MGC018 2.7 mg/kg every 4 weeks
Experimental: Part 2: Anal cancer cohort - MGC018 2.7 mg/kg every 4 weeks
Experimental: Part 2: HNSCC cohort - MGC018 2.7 mg/kg every 4 weeks
Experimental: Part 2: Melanoma cohort - MGC018 2.7 mg/kg every 4 weeks
Experimental: Part 2: Squamous NSCLC cohort - MGC018 2.7 mg/kg every 4 weeks
Experimental: Part 2: SCLC cohort - MGC018 2.7 mg/kg every 4 weeks
Other interventions: vobramitamab duocarmazine 2.0 mg (Arm A)
2.0 mg/kg intravenous (IV) every 4 weeks
Other interventions: vobramitamab duocarmazine 2.7 mg (Arm B)
2.7 mg.kg IV every 4 weeks
Other interventions: vobramitamab duocarmazine
2.7 mg.kg IV every 4 weeks
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Radiographic progression free survival (rPFS) as determined by the investigator
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Assessment method [1]
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The rPFS is defined as the time from the date of randomization to the date of first documented progressive disease (PD) per Prostate Cancer Working Group 3 (PCWG3) or death from any cause, whichever occurs first. Three arms will be compared: Arm A, Arm B, and control.
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Timepoint [1]
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Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
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Primary outcome [2]
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Part 2: Objective response rate (ORR) per investigator assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
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Assessment method [2]
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The ORR is defined as the percentage of participants in the response evaluable poplaiton who achieve a best overall response of conplete response (CR) or partial response (PR), per RECIST version 1.1 criterial CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
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Timepoint [2]
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Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
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Secondary outcome [1]
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Part 1: ORR per PCWG3 criteria as determined by the investigator
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Assessment method [1]
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The number of participants experiencing a complete response (CR) or partial response (PR) to treatment.
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Timepoint [1]
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as determined by the investigator
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Secondary outcome [2]
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Part 1: Duration of response (DoR) per PCWG3 criteria as determined by the investigator
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Assessment method [2]
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The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
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Timepoint [2]
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Every 8 weeks throughout study participation, up to 2 years
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Secondary outcome [3]
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Part 1: Prostate-specific Cancer Antigen (PSA) response rate per PCWG3 criteria
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Assessment method [3]
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PSA response is defined as a = 50% decline in PSA from baseline with PSA confirmation = 3 weeks after the first documented reduction in PSA of = 50%.
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Timepoint [3]
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Every 4 weeks throughout study participation, up to 2 years
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Secondary outcome [4]
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Part 1: Time to PSA progression per PCWG3 criteria
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Assessment method [4]
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In participants with a decrease in PSA from baseline, PSA progression is defined as a = 25% increase and an absolute increase of = 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained = 3 weeks later.
In participants with no decrease in PSA from baseline, PSA progression is defined as a = 25% increase and an absolute increase of = 2 ng/mL above the baseline value after 12 weeks.
Time to PSA progression is defined as the time from the date of randomization to the first PSA progression.
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Timepoint [4]
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Every 4 weeks throughout study participation, up to 2 years
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Secondary outcome [5]
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Part 1: Duration of PSA response per PCWG3 criteria
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Assessment method [5]
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Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
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Timepoint [5]
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Every 4 weeks throughout study participation, up to 2 years
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Secondary outcome [6]
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Part 1: PSA percent change over time
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Assessment method [6]
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Timepoint [6]
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Every 4 weeks throughout study participation, up to 2 years
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Secondary outcome [7]
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Part 1: Best PSA percent change
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Assessment method [7]
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Timepoint [7]
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Every 4 weeks throughout study participation, up to 2 years
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Secondary outcome [8]
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Part 1: Time to first symptomatic skeletal event (SSE)
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Assessment method [8]
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An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.
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Timepoint [8]
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Every 4 weeks throughout the study, up to 2 years
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Secondary outcome [9]
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Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation.
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Assessment method [9]
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Timepoint [9]
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Throughout the study, up to 2 years
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Secondary outcome [10]
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Number of participants who develop anti-drug antibodies
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Assessment method [10]
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Timepoint [10]
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Throughout the study, up to 2 years
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Secondary outcome [11]
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Part 2: DoR per investigator assessment of RECIST 1.1 criteria
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Assessment method [11]
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The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.
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Timepoint [11]
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Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
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Secondary outcome [12]
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Part 2: Progression free survival (PFS) per investigator assessment of RECIST 1.1 criteria
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Assessment method [12]
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PFS is defined as the time from the date of the first dose to the date of first PD per RECIST 1.1 criteria or death from any cause, whichever occurs first.
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Timepoint [12]
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Every 8 weeks for the first 24 weeks, then every 12 weeks, up to 2 years
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Eligibility
Key inclusion criteria
- Part 1 only: Histologically confirmed adenocarcinoma of the prostate without evidence
of neuroendocrine differentiation, signet cell, or small cell features.
- Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous
NSCLC, or SCLC.
- Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic,
castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of
<60 days used as bridging to lutetium-177 is permitted.
- Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic
disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with
HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or
metastatic disease.
- All participants must have = 1 metastatic lesion, according to RECIST 1.1 or PCWG3
criteria, that is present on magnetic resonance imaging (MRI), computed tomography
(CT), or bone scan obtained = 28 days prior to initiation of study treatment.
- All participants must have tumor progression, according to disease-specific criteria,
following their most recent anti-cancer therapy.
- All participants must have and available archival or formalin-fixed paraffin-embedded
(FFPE) tumor tissue sample for participants with metastasis to internal organs
- All participants have acceptable physical condition and laboratory values.
- All participants of childbearing potential must agree to use highly effective methods
of birth control.
- All participants must not be pregnant, planning to be pregnant, or breastfeeding.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any underlying medical or psychiatric condition impairing participant's ability to
receive, tolerate, or comply with the planned treatment or study procedures.
- Part 1 only: Received >1 prior taxane-containing regimen for prostate cancer. A second
taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
- Part 1 only: Received >3 total prior therapies for mCRPC
- Part 1 only: Participants with known BRCA or ATM mutation (germline or somatic) are
not eligible unless they received prior treatment with a PARP inhibitor where
available, indicated and tolerated.
- Another hematologic or solid tumor = stage 1 malignancy that completed surgery, last
dose of radiotherapy, or last dose of systemic anti-cancer therapy = 2 years from
first dose of study treatment. Participants who had curative therapy for
non-melanomatous skin cancer or for localized malignancy are eligible.
- Untreated, symptomatic central nervous system (CNS) metastasis.
- Prior treatment with any B7-H3 targeted agent for cancer,
- Contradictions to the use of corticosteroid treatment
- Prior stem cell, tissue, or solid organ transplant.
- Part 1 only: Use of products that have published anti-prostate cancer activity or are
known to decrease PSA.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2027
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Actual
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Sample size
Target
382
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Ramsay Health Care - Westmead Private Hospital - Westmead
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Recruitment hospital [2]
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The University of Queensland (UQ) - Princess Alexandra Hospital (PAH) - Woolloongabba
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Recruitment hospital [3]
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Cabrini Health- Malvern - Malvern
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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Louisiana
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Maryland
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Michigan
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Minnesota
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Ohio
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Oregon
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South Carolina
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Virginia
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United States of America
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Washington
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Belgium
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Brussles
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Belgium
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Hainaut
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Belgium
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Luxembourg
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Belgium
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Namur
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Belgium
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Gent
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France
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AM
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France
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Bas Rhin
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France
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Gironde
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Herault
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France
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Ile De France
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France
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Ille Et Vilaine
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France
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Sarthe
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France
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Val De Marne
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France
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Brest
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France
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Paris
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Italy
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TO
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Italy
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Venice
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Italy
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Florence
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Italy
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Padova
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Italy
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Trento
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Korea, Republic of
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Daegu
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Korea, Republic of
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Kyonggi
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Seoul
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Poland
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Mazowieckie
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Poland
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Wlkp
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Poland
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Zachodniopomorskie
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Spain
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Barcelona
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Spain
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Seville
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Spain
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Lugo
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Spain
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Madrid
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United Kingdom
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Surrey
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MacroGenics
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Study CP-MGC018-03 is an open-label, two-part, Phase 2 study. Part 1 of the study will enroll
participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated
with one prior androgen receptor axis-targeted therapy (ARAT). ARAT includes abiraterone,
enzalutamide, or apalutamide. Participants may have received up to 1 prior
docetaxel-containing regimen, but no other chemotherapy agents.
This part of the study will assess the efficacy and tolerability of vobramitamab duocarmazine
(MGC018) in two experimental arms (2.0 mg/kg every 4 weeks [Q4W] and 2.7 mg/kg Q4W) .
Approximately 100 participants will be randomized 1:1.
Part 2 of the study will enroll participants with locally advanced or metastatic squamous
cell carcinoma (SCC) of the anus, melanoma, head and neck squamous cell carcinoma (HNSCC),
squamous non-small cell lung carcinoma (NSCLC), and small cell lung carcinoma (SCLC).
Participants must have progressive following at least 1 prior line of standard chemotherapy
for advanced or metastatic disease. Participants will receive vobramitamab docarmazine at a
dose of 2.7 mg/kg every 4 weeks. Up to 200 participants may be enrolled in Part 2.
In both parts, vobramitamab duocarmazine will be administered intravenously (IV) in clinic on
Day 1 of each 4-week cycle. Vobramitamab duocarmazine will be administered for up to 26
cycles, approximately 2 years, until criteria for treatment discontinuation are met.
Participants will undergo regular testing for signs of disease progression using computed
tomography (CT) scans, magnetic resonance imaging (MRI), bone scans, and prostate-specific
antigen (PSA) blood tests. Routine examinations and blood tests will be performed and
evaluated by the study doctor.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05551117
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ashley Ward, M.D.
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Address
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MacroGenics
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05551117
Download to PDF