A Study of BG-C477 in Participants With Advanced Solid Tumors

Description

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.

Conditions

Advanced Solid Tumors

Study Overview

Study Details

Study overview

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.

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

A Study of BG-C477 in Participants With Advanced Solid Tumors

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

New Haven

Yale University, Yale Cancer Center, New Haven, Connecticut, United States, 06520

Westwood

The University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Houston

The University of Texas Md Anderson Cancer Center, Houston, Texas, United States, 77030-4009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who 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
  • * ≥ 1 measurable lesion as assessed by RECIST v1.1
  • * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • * Adequate organ function
  • * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477 and for ≥ 6 months after the last dose of chemotherapy, whichever comes later
  • * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, and for ≥ 3 months after chemotherapy, whichever comes later.
  • * Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
  • * History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
  • * Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • * Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2028-10-27