A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors
BeOne Medicines
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).
Description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced or metastatic solid tumors. 2. Life expectancy of ≥ 3 months. 3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and/or a platinum in the advanced or met…
Interventions
- DrugBG-C137
Administered intravenously
- DrugAnticancer Agents
Administered intravenously or orally
Locations (52)
- Usc Norris Comprehensive Cancer Center (Nccc)Los Angeles, California
- Yale Cancer CenterNew Haven, Connecticut
- Mayo Clinic RochesterRochester, Minnesota
- Md Anderson Cancer CenterHouston, Texas
- Fred Hutchinson Cancer Research CenterSeattle, Washington
- University of WisconsinMadison, Wisconsin