BGB-B455 for Solid Tumors

Recruiting at 14 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Chemotherapy, Immunotherapy, Targeted therapy, others

Disqualifiers: Recent surgery, Live vaccine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors. The main questions it aims to answer are: * What is the recommended dosing for BGB-B455? * What medical problems do participants have when taking BGB-B455? The study has two parts: * Phase 1a: dose escalation and safety expansion * Phase 1b: dose expansion

Will I have to stop taking my current medications?

The trial requires that you stop taking any prior systemic anticancer therapy, including chemotherapy, immunotherapy, and targeted therapy, at least 14 days or 5 half-lives before starting the study drug. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that have a protein called CLDN6. Participants must have at least one measurable tumor, be in stable condition (ECOG 0 or 1), and have good organ function. They should also agree to provide tissue samples for testing. It's not for those who haven't tried standard treatments unless they couldn't tolerate them.

Inclusion Criteria

My tumor tests positive for CLDN6.

I have at least one tumor that can be measured.

My physical health allows me to do all or most of my usual activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation and Safety Expansion

Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy, followed by a safety expansion at selected doses

7 months

Phase 1b: Dose Expansion

Participants will be enrolled at the best dose found in Phase 1a to evaluate efficacy in selected indications

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BGB-B455

Trial Overview The study tests BGB-B455, which targets tumors with the CLDN6 protein. The trial has two parts: Phase 1a to find the right dose and check safety, followed by Phase 1b to confirm the dose's effects on a larger group of participants.

Participant Groups

Group I: Phase 1b: Dose Expansion Experimental Treatment 1 Intervention

Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-B455 as monotherapy determined from Phase 1a will be evaluated for selected indications based on emerging data.

Group II: Phase 1a: Dose Escalation and Safety Expansion Experimental Treatment 1 Intervention

Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+