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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/NCT06257264




Registration number
NCT06257264
Ethics application status
Date submitted
5/02/2024
Date registered
13/02/2024
Date last updated
24/04/2024

Titles & IDs
Public title
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Scientific title
A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
BG-68501-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Small Cell Lung Cancer 0 0
Ovarian Cancer 0 0
Gastric Cancer 0 0
Hormone-receptor-positive Breast Cancer 0 0
Hormone Receptor Positive HER-2 Negative Breast Cancer 0 0
Advanced Solid Tumor 0 0
Endometrial Cancer 0 0
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to approximately 24 months
Primary outcome [2] 0 0
Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501
Timepoint [2] 0 0
Up to approximately 24 months
Primary outcome [3] 0 0
Part 1: Recommended dose(s) for Expansion (RDFE) of BG-68501 in participants with solid tumors
Timepoint [3] 0 0
Up to approximately 24 months
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to approximately 24 months
Primary outcome [5] 0 0
Part 2: Objective Response Rate
Timepoint [5] 0 0
Up to approximately 24 months
Secondary outcome [1] 0 0
Part 1: ORR
Timepoint [1] 0 0
Up to approximately 24 months
Secondary outcome [2] 0 0
Part 2: Number of participants with AEs and SAEs
Timepoint [2] 0 0
Up to approximately 24 months
Secondary outcome [3] 0 0
Parts 1 and 2: Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 24 months
Secondary outcome [4] 0 0
Parts 1 and 2: Time to Response (TTR)
Timepoint [4] 0 0
Up to approximately 24 months
Secondary outcome [5] 0 0
Parts 1 and 2: Disease Control Rate (DCR)
Timepoint [5] 0 0
Up to approximately 24 months
Secondary outcome [6] 0 0
Parts 1 and 2: Clinical Benefit Rate (CBR)
Timepoint [6] 0 0
Up to approximately 24 months
Secondary outcome [7] 0 0
Part 1: Maximum observed plasma concentration (Cmax) for BG-68501
Timepoint [7] 0 0
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Secondary outcome [8] 0 0
Part 1: Observed plasma trough concentration (Ctrough) for BG-68501
Timepoint [8] 0 0
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Secondary outcome [9] 0 0
Part 1: Area under the concentration-time curve (AUC) for BG-68501
Timepoint [9] 0 0
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Secondary outcome [10] 0 0
Part 1: Half-life (t1/2) for BG-68501
Timepoint [10] 0 0
From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Secondary outcome [11] 0 0
Part 2: Plasma concentrations for BG-68501
Timepoint [11] 0 0
From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Genesiscare North Shore - St Leonards
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06257264
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06257264