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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06257264
Registration number
NCT06257264
Ethics application status
Date submitted
5/02/2024
Date registered
13/02/2024
Titles & IDs
Public title
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
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Scientific title
A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors
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Secondary ID [1]
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BG-68501-101
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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:
Breast Cancer
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Small Cell Lung Cancer
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Ovarian Cancer
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Gastric Cancer
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Hormone-receptor-positive Breast Cancer
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Hormone Receptor Positive HER-2 Negative Breast Cancer
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Advanced Solid Tumor
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Endometrial Cancer
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Prostate Cancer
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Condition category
Condition code
Cancer
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Breast
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Cancer
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Prostate
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Cancer
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Ovarian and primary peritoneal
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Cancer
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Stomach
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Cancer
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Lung - Small cell
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Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BG-68501
Treatment: Drugs - Fulvestrant
Experimental: Part 1: Dose Escalation and Safety Expansion - Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy and in combination with fulvestrant.
Experimental: Part 2: Dose Expansion - The RFDE for BG-68501 (as monotherapy and in combination with fulvestrant) from Part 1 will be evaluated in selected tumor cohorts.
Treatment: Drugs: BG-68501
Planned doses administered orally.
Treatment: Drugs: Fulvestrant
Standard dose administered via intramuscular injection.
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Intervention code [1]
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Treatment: Drugs
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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: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Number of participants with treatment-emergent AEs and SAEs.
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Timepoint [1]
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Up to approximately 24 months
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Primary outcome [2]
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Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501
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Assessment method [2]
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MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
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Timepoint [2]
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Up to approximately 24 months
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Primary outcome [3]
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Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 in participants with solid tumors
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Assessment method [3]
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RDFE of BG-68501 alone will be determined based upon the MTD or MAD.
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Timepoint [3]
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Up to approximately 24 months
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Primary outcome [4]
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Part 1: RDFE of BG-68501 and fulvestrant in participants with hormone-receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer
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Assessment method [4]
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RDFE of BG-68501 in combination with fulvestrant will be determined based upon the MTD or MAD.
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Timepoint [4]
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Up to approximately 24 months
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Primary outcome [5]
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Part 2: Objective Response Rate
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Assessment method [5]
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ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). CR and PR that is confirmed by repeat assessments, as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Timepoint [5]
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Up to approximately 24 months
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Secondary outcome [1]
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Part 1: ORR
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Assessment method [1]
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ORR is defined as the percentage of participants with best overall response of CR or PR. CR and PR that is confirmed by repeat assessments, as assessed by the investigator using RECIST v1.1.
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Timepoint [1]
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Up to approximately 24 months
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Secondary outcome [2]
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Part 2: Number of participants with AEs and SAEs
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Assessment method [2]
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Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
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Timepoint [2]
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Up to approximately 24 months
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Secondary outcome [3]
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Parts 1 and 2: Duration of Response (DOR)
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Assessment method [3]
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DOR is defined as the time from the first confirmed objective response by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first.
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Timepoint [3]
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Up to approximately 24 months
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Secondary outcome [4]
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Parts 1 and 2: Time to Response (TTR)
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Assessment method [4]
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TTR is defined as the time from the treatment initiation to the first determination of overall response by the investigator using RECIST v1.1.
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Timepoint [4]
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Up to approximately 24 months
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Secondary outcome [5]
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Parts 1 and 2: Disease Control Rate (DCR)
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Assessment method [5]
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DCR is defined as the percentage of participants with the best overall response, of a CR, PR, and stable disease assessed by the investigator using RECIST v1.1.
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Timepoint [5]
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Up to approximately 24 months
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Secondary outcome [6]
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Parts 1 and 2: Clinical Benefit Rate (CBR)
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Assessment method [6]
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CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting = 24 weeks.
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Timepoint [6]
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Up to approximately 24 months
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Secondary outcome [7]
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Part 1: Maximum observed plasma concentration (Cmax) for BG-68501
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Assessment method [7]
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Timepoint [7]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [8]
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Part 1: Observed plasma trough concentration (Ctrough) for BG-68501
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Assessment method [8]
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Timepoint [8]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [9]
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Part 1: Area under the concentration-time curve (AUC) for BG-68501
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Assessment method [9]
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Timepoint [9]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [10]
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Part 1: Half-life (t1/2) for BG-68501
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Assessment method [10]
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Timepoint [10]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [11]
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Part 2: Plasma concentrations for BG-68501
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Assessment method [11]
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Timepoint [11]
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From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days)
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Eligibility
Key inclusion criteria
General
* Female participants with advanced or metastatic HR+/HER2- breast cancer will be required to have ovarian function suppression using gonadotropin hormone-releasing hormone (GnRH) agonists (such as goserelin) or be postmenopausal.
* Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
* Adequate organ function.
Part 1 (Dose Escalation)
* Participants with histologically or cytologically confirmed advanced or metastatic solid tumors potentially associated with CDK2 dependency including HR+/HER2- breast cancer, platinum refractory or resistant serous ovarian, fallopian tube, primary peritoneal cancer (PROC), small cell lung cancer (SCLC), and others.
* Participants should have received prior available systemic therapy for their condition and should be refractory to or intolerant of standard-of-care therapies.
* Participants with advanced solid tumors must have measurable disease per RECIST 1.1.
Part 1 (Safety Expansion)
* Participants with advanced or metastatic HR+/HER2- breast cancer, PROC, or SCLC.
Part 2 (Dose Expansion)
* Participants with selected advanced or metastatic HR+/HER2- breast cancer, PROC, SCLC, or advanced solid tumors with a specific gene mutation based on standard-of-care testing.
General
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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
* Prior therapy selectively targeting CDK2 inhibition. Prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available.
* Known leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated central nervous system (CNS) metastases may be eligible if they meet additional criteria.
* Any malignancy = 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* Uncontrolled diabetes.
* Infection requiring systemic antibacterial, antifungal, or antiviral therapy antiviral therapy = 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
* History of hepatitis B or active hepatitis C infection.
* Any major surgical procedure = 28 days before the first dose of study treatment(s).
* Prior allogeneic stem cell transplantation, or organ transplantation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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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
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
28/02/2024
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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
31/12/2026
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Actual
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Sample size
Target
108
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Genesiscare North Shore - St Leonards
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Recruitment hospital [3]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [4]
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Cancer Research South Australia - Adelaide
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Recruitment hospital [5]
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Monash Health - Clayton
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3168 - Clayton
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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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Florida
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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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Missouri
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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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New Jersey
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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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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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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
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors. The study will also identify a recommended dose for expansion (RDFE) in subsequent disease directed studies. The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion) and Part 2 (dose expansion).
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Trial website
https://clinicaltrials.gov/study/NCT06257264
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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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Study Director
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Address
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BeiGene
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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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Study Director
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Address
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Country
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Phone
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1.877.828.5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06257264