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CDK2 Inhibitor

Part 1: Dose Escalation and Safety Expansion for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with advanced or metastatic HR+/HER2- breast cancer, PROC, or SCLC

Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

Study Summary

This trial is testing a new drug called BG-68501 in patients with advanced solid tumors to see if it is safe, how the body processes it, its effects on the tumor, and its initial

Who is the study for?

This trial is for adults with advanced-stage tumors, including breast, ovarian, endometrial, prostate, stomach cancers and SCLC. They must have tried standard treatments without success or be unable to tolerate them. Women with certain types of breast cancer need hormone suppression or be postmenopausal. Participants should be relatively healthy otherwise (ECOG ≤ 1) and have measurable disease.Check my eligibility

What is being tested?

The study tests BG-68501, a new drug aimed at stopping tumor growth by inhibiting CDK2—a protein that helps cancer cells multiply. It's given in two parts: first to find the safest dose (dose escalation), then to see how well it works at this dose (dose expansion). The trial also includes Fulvestrant for comparison.See study design

What are the potential side effects?

Possible side effects are not detailed but may include typical reactions related to drugs targeting cell division such as fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems; specific side effects will become clearer as the trial progresses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread, and it is either HR+/HER2-, ovarian, or small cell lung cancer.

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I am fully active or can carry out light work.

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My cancer is advanced or has spread and may respond to treatments targeting CDK2.

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I am a woman with advanced breast cancer and am either postmenopausal or receiving hormone therapy to suppress ovarian function.

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I've tried all standard treatments for my condition without success or couldn't tolerate them.

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My cancer is advanced, has specific gene mutations, and is not HER2 positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-68501

Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

+2 more

Secondary outcome measures

Part 1: Area under the concentration-time curve (AUC) for BG-68501

Part 1: Half-life (t1/2) for BG-68501

Part 1: Maximum observed plasma concentration (Cmax) for BG-68501

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment2 Interventions

The RFDE for BG-68501 (as monotherapy and in combination with fulvestrant) from Part 1 will be evaluated in selected tumor cohorts.

Group II: Part 1: Dose Escalation and Safety ExpansionExperimental Treatment2 Interventions

Sequential cohorts of increasing dose levels of BG-68501 will be evaluated as monotherapy and in combination with fulvestrant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,717 Total Patients Enrolled

Study DirectorStudy DirectorBeiGene

1,215 Previous Clinical Trials

499,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase for this medical study currently ongoing?

"According to clinicaltrials.gov, this investigation is currently seeking eligible individuals. The trial was initially listed on 2/28/2024 and most recently revised on 4/23/2024."

Answered by AI

In how many locations is this trial currently being conducted?

"There are a total of 5 active facilities participating in this trial, such as Titan Health Partners Llc Dba Astera Cancer Care located in East Brunswick, Mary Crowley Cancer Research based in Dallas, and Genesiscare North Shore situated in St Leonards, alongside additional sites."

Answered by AI

What is the level of risk associated with Phase 1: Dosage Increase and Safety Expansion for individuals?

"Given the limited safety and efficacy data available for Part 1: Dose Escalation and Safety Expansion, it has been rated a 1 on our internal scale at Power. This aligns with its Phase 1 trial status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06257264.

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