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OncoMatch/Clinical Trials/NCT06803680

A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors

Is NCT06803680 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including BGB-B455 and Chemotherapy for advanced solid tumor.

Phase 1RecruitingBeiGeneNCT06803680Data as of Jun 2026Location: United States · Australia · China

Treatment: BGB-B455 · ChemotherapyThe 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

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Extracted eligibility criteria

Treatments studied

Other

BGB-B455Chemotherapy

Cancer type

Tumor Agnostic

Biomarker criteria

Required: CLDN6 overexpression (CLDN6+ by central immunohistochemistry)

Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.

Disease stage

Metastatic disease required

advanced or metastatic, and unresectable solid tumors; ≥ 1 measurable lesion as assessed by RECIST v1.1

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard systemic therapy — advanced or metastatic disease

who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated

Cannot have received: systemic anticancer therapy

Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese [or other country] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).

Lab requirements

Blood counts

Kidney function

Liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Adventhealth · Celebration, Florida
  • Sidney Kimmel Cancer Center · Philadelphia, Pennsylvania
  • Avera Cancer Institute · Sioux Falls, South Dakota
  • Next Oncology · San Antonio, Texas
  • Fred Hutchinson Cancer Research Center · Seattle, Washington

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06803680 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior systemic anticancer therapy disqualifies patients from enrollment.

Does this trial require CLDN6?

Yes, CLDN6 overexpression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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