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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/NCT03729596
Registration number
NCT03729596
Ethics application status
Date submitted
30/10/2018
Date registered
2/11/2018
Date last updated
23/04/2024
Titles & IDs
Public title
MGC018 With or Without MGA012 in Advanced Solid Tumors
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Scientific title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors
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Secondary ID [1]
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CP-MGC018-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of Head and Neck
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Triple Negative Breast Cancer
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Melanoma
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Advanced Solid Tumor, Adult
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Metastatic Castrate Resistant Prostate Cancer
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Non Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Breast
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - vobramitamab duocarmazine
Experimental: Cohort 1 - 0.5 mg/kg IV every 3 weeks
Experimental: Cohort 2 - 1.0 mg/kg IV every 3 weeks
Experimental: Cohort 3 - 2.0 mg/kg IV every 3 weeks
Experimental: Cohort 4 - 3.0 mg/kg IV every 3 weeks
Experimental: Cohort 5 - 4.0 mg/kg IV every 3 weeks
Experimental: mCRPC expansion - 3.0 mg/kg IV every 3 weeks
Experimental: NSCLC expansion - 3.0 mg/kg IV every 3 weeks
Experimental: TNBC expansion - 3.0 mg/kg IV every 3 weeks
Experimental: Melanoma expansion - 3.0 mg/kg IV every 3 weeks
Experimental: SCCHN expansion - 3.0 mg/kg IV every 3 weeks
Other interventions: vobramitamab duocarmazine
Anti-B7H3 antibody drug conjugate
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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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Number of patients with Adverse Events of vobramitamab duocarmazine as assessed by CTCAE v4.03
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Assessment method [1]
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Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
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Timepoint [1]
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Throughout the study up to 24 months
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Primary outcome [2]
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Number of patients with dose limiting toxicities (DLT)
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Assessment method [2]
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Maximum tolerated or maximum administered dose of vobramitamab duocarmazine
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Timepoint [2]
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up to 42 days from first dose
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Secondary outcome [1]
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Best overall response (BOR) of vobramitamab duocarmazine
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Assessment method [1]
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The best response recorded from the start of the study treatment until the end of treatment with vobramitamab duocarmazine, taking into account any requirement for confirmation of response.
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Timepoint [1]
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Throughout the study for up to 24 months
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Secondary outcome [2]
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Objective response rate (ORR) of vobramitamab duocarmazine
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Assessment method [2]
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The percentage of participants who achieve a complete response (CR or partial response (PR) to treatment with vobramitamab duocarmazine
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Timepoint [2]
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Efficacy evaluations every 9 weeks throughout the study for up to 24 months
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Secondary outcome [3]
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Progression free survival (PFS) of vobramitamab duocarmazine
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Assessment method [3]
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Efficacy assessed as the first dose date to the date of first documented progression using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first.
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Timepoint [3]
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Every 9 weeks for up to 24 months
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Secondary outcome [4]
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Duration of response (DoR) of vobramitamab duocarmazine
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Assessment method [4]
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Efficacy assessed as the time from the date of initial objective response to the date of first documented progression RECIST v1.1, or the date of death from any cause, whichever occurs first.
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Timepoint [4]
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Throughout the study for up to 48 months
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Secondary outcome [5]
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Overall survival (OS) of vobramitamab duocarmazine
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Assessment method [5]
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Efficacy assessed as the time from the first dose date to the date of death from any cause.
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Timepoint [5]
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Every 9 weeks for up to 24 months
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Secondary outcome [6]
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PSA response rate
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Assessment method [6]
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Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA) with confirmation at least 3 weeks later
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Timepoint [6]
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Every 3 weeks up to 24 months
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Secondary outcome [7]
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Best PSA response
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Assessment method [7]
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For prostate cancer patients, the greatest change from baseline in PSA.
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Timepoint [7]
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Every 3 weeks up to 24 months
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Secondary outcome [8]
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Area under the curve
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Assessment method [8]
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Area under the plasma concentration versus time curve of vobramitamab duocarmazine
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Timepoint [8]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months
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Secondary outcome [9]
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Cmax
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Assessment method [9]
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Maximum Plasma Concentration of vobramitamab duocarmazine
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Timepoint [9]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months
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Secondary outcome [10]
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Tmax
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Assessment method [10]
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Time to reach maximum (peak) plasma concentration of vobramitamab duocarmazine
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Timepoint [10]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months
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Secondary outcome [11]
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Ctrough
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Assessment method [11]
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Trough plasma concentration of vobramitamab duocarmazine
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Timepoint [11]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months
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Secondary outcome [12]
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CL
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Assessment method [12]
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Total body clearance of the drug from plasma of vobramitamab duocarmazine and vobramitamab duocarmazine+retifanlimab
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Timepoint [12]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months
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Secondary outcome [13]
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Vss
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Assessment method [13]
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Apparent volume of distribution at steady state of vobramitamab duocarmazine
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Timepoint [13]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months
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Secondary outcome [14]
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t1/2
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Assessment method [14]
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Terminal half life of vobramitamab duocarmazine
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Timepoint [14]
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Cycle 1 (each cycle is 21 days) and Cycle 2: Predose, end of infusion (EOI), 1, 4, 24, 72 hours post-infusion and predose on Days 8, 15 and 22; Predose and EOI samples collected at Day 1 Cycle 3 and afterwards for up to 24 months .
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Secondary outcome [15]
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Immunogenicity
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Assessment method [15]
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Percent of patients with anti-drug antibodies against vobramitamab duocarmazine
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Timepoint [15]
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Every 3 weeks through end of treatment, up to 24 months
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Eligibility
Key inclusion criteria
- Tissue specimen available for retrospective analysis of B7-H3 and PD-L1 expression.
- Eastern Cooperative Oncology Group performance status of =2
- Life expectancy = 12 weeks for dose escalation phase and = 24 weeks for cohort
expansion phase
- Measurable disease. Prostate cancer patients with bone only disease are eligible.
- Acceptable laboratory parameters and adequate organ reserve.
- Dose Escalation Phase: Patients with histologically proven, unresectable, locally
advanced or metastatic solid tumors for whom no therapy with demonstrated clinical
benefit is available.
Module A Cohort Expansion:
- mCRPC that has progressed with one prior line of chemotherapy for metastatic disease
and no more than two prior lines of anti-hormonal therapy.
- NSCLC: metastatic disease after standard cytotoxic, targeted, and biologic or
checkpoint inhibitor therapy. No more than 2 prior lines of chemotherapy.
- TNBC: Locally advance or metastatic disease that has progressed following at least one
systemic therapy.
- SCCHN that has progressed during or following at least one systemic therapy for
metastatic or recurrent unresectable disease. No more than 2 prior lines of
chemotherapy.
- Melanoma that has progressed during or following at least one systemic treatment for
unresectable locally advanced or metastatic disease. Patients who are intolerant of or
refused standard therapy are eligible.
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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
- Patients with history of prior central nervous system (CNS) metastasis must have been
treated, be asymptomatic, and not have concurrent treatment for CNS disease,
progression of CNS metastases on MRI, CT or PET within 6 months, or history of
leptomeningeal disease or cord compression at the time of enrollment.
- Prior treatment with B7-H3 targeted agents for cancer.
- Treatment with systemic cancer therapy, biologic agents, or anti-hormonal therapy
(mCRPC) within 4 weeks, prior small molecule targeted or kinase inhibitors within 14
days or 5 half-lives, prior radioligand within 6 months
- Clinically significant cardiovascular disease.
- Clinically significant pulmonary compromise or requirement for supplemental oxygen.
- History of clinically-significant cardiovascular disease, including but not limited to
pericarditis or pericardial effusion.
- Active viral (including confirmed or presumed COVID-19), bacterial, or systemic fungal
infection requiring parenteral treatment within 7 days of first study drug
administration.
- Known history of hepatitis B or C infection or known positive test for hepatitis B
surface antigen or core antigen, or hepatitis C polymerase chain reaction.
- Known positive testing for human immunodeficiency virus or history of acquired immune
deficiency syndrome.
- Major trauma or major surgery within 4 weeks of first study drug administration.
- Clinically significant venous insufficiency.
- > Grade 1 peripheral neuropathy.
- Evidence of pleural effusion.
- Evidence of ascites.
- Serum testosterone >50 ng/dl or >1.7 nmol/L in mCRPC in Module A Cohort Expansion
Phase
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
21/11/2018
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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
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Actual
18/03/2023
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Sample size
Target
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Accrual to date
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Final
143
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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St Vincent's Health Network (Kinghorn Cancer Centre) - Darlinghurst
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Recruitment hospital [2]
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Austin Health - Olivia Newton John Cancer Center - Heidelberg
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Recruitment hospital [3]
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Calvary Mater NewCastle - Waratah
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Recruitment hospital [4]
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The University of Queensland - Princess Alexandra Hospital (PAH) - Woolloongabba
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment postcode(s) [3]
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2298 - Waratah
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Recruitment postcode(s) [4]
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4105 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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District of Columbia
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Country [3]
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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Nebraska
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Country [6]
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United States of America
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State/province [6]
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Nevada
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Virginia
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Country [9]
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Poland
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State/province [9]
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Krakow
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Country [10]
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Poland
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State/province [10]
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Poznan
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Country [11]
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Poland
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State/province [11]
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Warsaw
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Country [12]
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Poland
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State/province [12]
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Warszawa
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Country [13]
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Spain
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State/province [13]
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Barcelona
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Country [14]
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Spain
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State/province [14]
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Madrid
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK)
pharmacodynamics and preliminary antitumor activity of vobramitamab duocarmazine (MGC018) in
patients with advanced solid tumors. Patients with solid tumors will be enrolled in the Dose
Escalation Phase; Cohort Expansion will include metastatic castrate-resistant prostate cancer
(mCRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), squamous
cell carcinoma of the head and neck (SCCHN), and melanoma. Patients who do not experience
unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional
cycles for up to two years. Patients in Cohort Expansion will be followed for survival every
3 months for 2 years following last dose.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03729596
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03729596
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