A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors
BeOne Medicines
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.
Description
This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents. Note: 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: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent * Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy * Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator * Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid…
Interventions
- DrugBG-C477
Administered intravenously.
- DrugTislelizumab
Administered intravenously.
- DrugChemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Locations (32)
- City of Hope Phoenix Cancer CenterGoodyear, Arizona
- City of Hope National Medical CenterDuarte, California
- Yale University, Yale Cancer CenterNew Haven, Connecticut
- The University of Kansas Cancer CenterWestwood, Kansas
- John Theurer Cancer Center Hackensack University Medical CenterHackensack, New Jersey
- The University of Texas Md Anderson Cancer CenterHouston, Texas