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Chimeric Degradation Activation Compound
BG-60366 for Non-Small Cell Lung Cancer
Denver, CO
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
Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI)
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Must not have
Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs)
Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, BG-60366, that targets a specific mutation in lung cancer cells. The study aims to see how safe and effective BG-60366 is in treating patients
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Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. Participants must have progressed after treatment with an EGFR-tyrosine kinase inhibitor and be ineligible for or have progressed on standard treatments like platinum-based chemotherapy. They should have at least one measurable tumor lesion and a stable physical status.Check my eligibility
What is being tested?
The study tests BG-60366, a new drug targeting mutant EGFR to treat NSCLC. It's an open-label trial with two parts: Phase 1a explores safe dosage levels and expands safety data, while Phase 1b focuses on confirming the dose's effectiveness against tumors.See study design
What are the potential side effects?
While specific side effects of BG-60366 are not listed here, similar drugs often cause symptoms like rash, diarrhea, dry skin, nail changes, mouth sores, fatigue, decreased appetite and potential liver function abnormalities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer has a specific EGFR mutation and I haven't started EGFR-TKI treatment.
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I am fully active or can carry out light work.
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My cancer worsened after treatment with a specific lung cancer drug and I can't have or didn't respond to standard treatments.
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My cancer has a specific mutation known to resist certain treatments.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken specific advanced drugs for EGFR mutation in my cancer.
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I have brain metastases needing urgent treatment.
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I have not had serious lung inflammation or ILD in the past 2 years.
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I frequently need drainage for fluid build-up in my chest or abdomen.
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My cancer was confirmed as small cell or mixed small cell/non-small cell before joining.
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I have symptoms from pressure on my spinal cord.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366
+2 moreSecondary study objectives
Phase 1a and 1b: Duration of Response (DOR)
Phase 1a and 1b: Time to Response (TTR)
Phase 1a: Overall Response Rate (ORR)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1b: Dose ExpansionExperimental Treatment1 Intervention
Recommended Dose(s) for Expansion (RDFE\[s\]) of BG-60366 as monotherapy determined from Phase 1a will be evaluated.
Group II: Phase 1a: Dose Escalation and Safety ExpansionExperimental Treatment1 Intervention
Sequential cohorts of increasing dose levels of BG-60366 will be evaluated as monotherapy.
Find a Location
Closest Location:University of Colorado· Denver, CO· 411 miles
Who is running the clinical trial?
BeiGeneLead Sponsor
215 Previous Clinical Trials
32,515 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,311 Previous Clinical Trials
573,016 Total Patients Enrolled