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

NCT06803680 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: BGB-B455-1012024-512931-64-00CTR20251939
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 13

Brief Summary

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

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

Claudin-6; CLDN6+; advanced or metastatic solid tumor; CD3; BsAb; bispecific antibody; CD3-BsAb; CLDN

Outcome Measures

Primary Outcomes (4)

• Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  Number of participants with AEs and SAEs, including laboratory abnormalities, and AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined adverse events of special interest (AESI) criteria.

  From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months

• Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455

  MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

  Approximately 1 month

• Phase 1a: RDFE of BGB-B455

  RDFE of BGB-B455 will be determined based upon the MTD or MAD.

  Approximately 1 month

• Phase 1b: Overall Response Rate (ORR)

  ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR must be confirmed by repeat assessments.

  Approximately 18 months

Secondary Outcomes (15)

• Phase 1a: ORR

  Approximately 18 months

• Phase 1a and 1b: Duration of Response (DOR)

  Approximately 18 months

• Phase 1a and 1b: Disease Control Rate (DCR)

  Approximately 18 months

• Phase 1a and 1b: Time to Response (TTR)

  Approximately 18 months

• Phase 1a and 1b: Serum concentrations of BGB-B455

  Approximately 7 months

Study Arms (2)

Phase 1a: Dose Escalation and Safety Expansion

EXPERIMENTAL

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

Drug: BGB-B455

Phase 1b: Dose Expansion

EXPERIMENTAL

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

Drug: BGB-B455; Drug: Chemotherapy

Interventions

Chemotherapy DRUG

Administered in accordance with relevant local guidelines and/or prescribing information.

Phase 1b: Dose Expansion

BGB-B455 DRUG

Planned doses administered on specified days per protocol.

Phase 1a: Dose Escalation and Safety Expansion; Phase 1b: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.
• Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.
• Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.
• ≥ 1 measurable lesion as assessed by RECIST v1.1.
• Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate organ function.

You may not qualify if:

• 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).
• Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).
• Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
• Any major surgical procedure ≤ 28 days before the first dose of study drug(s).
• History of prior ≥ Grade 3 cytokine release syndrome (CRS).
• Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (13)

Adventhealth

Celebration, Florida, 34747-4606, United States

RECRUITING

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107-4307, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105-2108, United States

RECRUITING

Next Oncology

San Antonio, Texas, 78229-6028, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, NSW 2170, Australia

RECRUITING

Mater Cancer Care Centre

South Brisbane, Queensland, QLD 4101, Australia

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

COMPLETED

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 330006, China

RECRUITING

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): April 29, 2028
• Study Completion (Estimated): April 29, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

AU (3); CN (5); US (5)