OncoMatch/Clinical Trials/NCT06257264
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
Is NCT06257264 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BG-68501 and Fulvestrant for breast cancer.
Treatment: BG-68501 · Fulvestrant · BGB-43395 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Small Cell Lung Cancer
Ovarian Cancer
Gastric Cancer
Tumor Agnostic
Endometrial Cancer
Prostate Cancer
Triple-Negative Breast Cancer
Urothelial Carcinoma
Disease stage
Required: Stage IV, NON-RESECTABLE
Metastatic disease required
advanced, non-resectable, or metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard-of-care systemic therapy — advanced/metastatic
Prior available standard-of-care systemic therapies for advanced or metastatic disease are required
Must have received: platinum-based chemotherapy — advanced
PROC participants must have received: ≥ 1 line of platinum-containing chemotherapy for advanced disease
Must have received: endocrine therapy — advanced/metastatic or adjuvant
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
Must have received: CDK4/6 inhibitor — adjuvant or advanced/metastatic
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
Cannot have received: CDK2 inhibitor
Prior therapy selectively targeting CDK2 inhibition
Cannot have received: CDK4 inhibitor
Exception: triple combination cohorts only
For triple combination cohorts: Prior therapy targeting CDK2 or selectively targeting CDK4
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation
Cannot have received: organ transplantation
organ transplantation
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hoag Memorial Presbyterian · Newport Beach, California
- Florida Cancer Specialists and Research Institute · Lake Mary, Florida
- Washington University School of Medicine · St Louis, Missouri
- Titan Health Partners Llc Dba Astera Cancer Care · East Brunswick, New Jersey
- Avera Cancer Institute · Sioux Falls, South Dakota
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