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

Part of paid clinical trials in Celebration, Florida.

Sponsor
BeOne Medicines
Study ID
NCT06803680
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BGB-B455 — DRUG
    Planned doses administered on specified days per protocol.
  • Chemotherapy — DRUG
    Administered in accordance with relevant local guidelines and/or prescribing information.

Study Details

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

Key Dates

First listed
Jan 31, 2025
Start date
Mar 18, 2025
Status verified
May 2026
Primary completion
Apr 29, 2028
Completion
Apr 29, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
AdventhealthCelebrationFlorida34747-4606-
Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-4307-
Avera Cancer InstituteSioux FallsSouth Dakota57105-2108-
Next OncologySan AntonioTexas78229-6028-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433-

Find similar trials in Celebration, FL

By research site
Adventhealth· Celebration, FLSidney Kimmel Cancer Center· Philadelphia, PAAvera Cancer Institute· Sioux Falls, SDNext Oncology· San Antonio, TXFred Hutchinson Cancer Research Center· Seattle, WA

Related Studies