Recruiting
Phase 1

BGB-B455

Sponsor:

BeOne Medicines

Code:

NCT06803680

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BGB-B455

Chemotherapy

Study Details

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

Study ID

NCT06803680

Start date

Mar 18, 2025

Status verified date

May, 2026

Completion date

Apr 29, 2028

Anticipated

Primary completion date

Apr 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Dose Escalation and Safety Expansion

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

experimental: Phase 1b: Dose Expansion

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.

Interventions

BGB-B455

Planned doses administered on specified days per protocol.

Chemotherapy

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

Primary outcome measure

  • Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 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 [ Time Frame: Approximately 1 month ]
  • Phase 1a: RDFE of BGB-B455 [ Time Frame: Approximately 1 month ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Approximately 18 months ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568clinicaltrials@beonemed.com

Locations

Adventhealth

Recruiting

Celebration, Florida, United States, 34747-4606

Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107-4307

Avera Cancer Institute

Recruiting

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

Next Oncology

Recruiting

San Antonio, Texas, United States, 78229-6028

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-4433

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 24, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-24.