Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06257264 | RECRUITING | Breast Cancer

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Sponsor:

BeiGene

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 as monotherapy and in combination with fulvestrant with or without BGB-43395, a selective CDK4 inhibitor, in adults with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC). The study will also identify a recommended dose for expansion (RDFE) for BG-68501 as monotherapy and in combination for subsequent disease directed studies. The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion, including evaluation of food effect) and Part 2 (dose expansion).

Condition or disease

Breast Cancer

Small Cell Lung Cancer

Ovarian Cancer

Gastric Cancer

Hormone-receptor-positive Breast Cancer

Hormone Receptor Positive HER-2 Negative Breast Cancer

Advanced Solid Tumor

Endometrial Cancer

Prostate Cancer

TNBC - Triple-Negative Breast Cancer

GastroEsophageal Cancer

Bladder Cancer

Intervention/treatment

BG-68501

Fulvestrant

BGB-43395

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 258 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors
Actual Study Start Date : 2024-03-11
Estimated Primary Completion Date : 2028-04
Estimated Study Completion Date : 2028-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Part 1 (Dose Escalation) Inclusion Criteria
  • * Monotherapy Cohorts: 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 cancer (PROC), endometrial cancer, and others. Prior available standard-of-care systemic therapies for advanced or metastatic disease are required. The requirements for enrollment into a food effect evaluation cohort are the same as the monotherapy cohorts with the exception that participants with gastric cancer and gastroesophageal adenocarcinoma are excluded.
  • * Combination Cohorts (BG-68501 with fulvestrant with or without BGB-43395): Enrollment is restricted to only participants with HR+/HER2- BC. In regions where approved and available, participants must have received one or more lines of treatment for advanced/metastatic disease as well as prior endocrine therapy and a CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting. If applicable, the requirements for enrollment into a food effect evaluation cohort are the same as the combination cohorts.
  • Part 1 (Safety Expansion) and Part 2 (Dose Expansion) Inclusion Criteria
    • * Participants with advanced, non-resectable, or metastatic HR+/HER2- BC or PROC, including fallopian tube or primary peritoneal cancer.
    • * PROC participants must have received
      • * ≥ 1 line of platinum-containing chemotherapy for advanced disease.
      • * ≤ 4 prior therapeutic regimens in the advanced/metastatic setting.
      • * HR+/HER2- BC
        • * Participants enrolled in regions where CDK4/6 inhibitors are approved and available must have received ≥ 1 line of therapy including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy or ADC treatments for advanced disease.
        • General Inclusion Criteria
          • * Female participants with advanced or metastatic HR+/HER2- BC 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.
          • * For dose escalation, participants with advanced solid tumors other than HR+/HER2- BC must have measurable disease per RECIST 1.1. Participants with HR+/HER2- BC with bone-only disease are eligible for dose escalation only. For safety expansion and dose expansion, all participants must have ≥1 measurable lesion per RECIST v 1.1.
          • General Exclusion Criteria
            • * For all cohorts: Prior therapy selectively targeting CDK2 inhibition.
            • * For triple combination cohorts: Prior therapy targeting CDK2 or selectively targeting CDK4. 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, treated papillary thyroid carcinoma, 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.
            • * Active hepatitis B infection 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.
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

Location Details

NCT06257264

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Hoag Memorial Presbyterian

Newport Beach, California, United States, 92663-4162

COMPLETED

United States, Florida

Florida Cancer Specialists and Research Institute

Lake Mary, florida, United States, 32746-2115

RECRUITING

United States, Missouri

Washington University School of Medicine

St Louis, Missouri, United States, 63110-1010

RECRUITING

United States, New Jersey

Titan Health Partners Llc Dba Astera Cancer Care

East Brunswick, New Jersey, United States, 08816-4096

RECRUITING

United States, South Dakota

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105-2108

RECRUITING

United States, Texas

Mary Crowley Cancer Research

dallas, Texas, United States, 75230

RECRUITING

Australia, New South Wales

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia, NSW 2148

RECRUITING

Australia, New South Wales

Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia, NSW 2010

RECRUITING

Australia, New South Wales

Nepean Hospital

Kingswood, New South Wales, Australia, NSW 2747

RECRUITING

Australia, New South Wales

Genesiscare North Shore

St Leonards, New South Wales, Australia, NSW 2065

RECRUITING

Australia, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, QLD 4102

RECRUITING

Australia, South Australia

Cancer Research South Australia

Adelaide, South Australia, Australia, AT 5000

RECRUITING

Australia, Victoria

Monash Health

Clayton, Victoria, Australia, VIC 3168

RECRUITING

China, Beijing Municipality

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

RECRUITING

China, Beijing Municipality

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

RECRUITING

China, Guangdong

Sun Yat Sen Memorial Hospital, Sun Yat Sen University (South)

Guangzhou, Guangdong, China, 510245

RECRUITING

China, Heilongjiang

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

RECRUITING

China, Hunan

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

RECRUITING

China, Liaoning

Shengjing Hospital Affiliated of China Medical University

Shenyang, Liaoning, China, 110022

RECRUITING

China, Shaanxi

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China, 710061

RECRUITING

Israel,

Rambam Health Care Center

Haifa, Israel, 3109601

RECRUITING

Israel,

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

RECRUITING

Moldova,

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, Moldova, 2025

RECRUITING

New Zealand,

Auckland City Hospital

Auckland, New Zealand, 1023