RECRUITING

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

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Conditions

Advanced Solid TumorBG-C9074TislelizumabAdvanced Solid Tumorsfirst-in-humanB7H4

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.

Official Title

Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2024-04-12
Study Completion:2028-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06233942

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
  2. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  3. 3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.
  4. 4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
  5. 5. Able to provide an archived tumor tissue sample.
  6. 6. Adequate bone marrow and organ function.
  7. 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
  8. 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).
  1. 1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.
  2. 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  3. 3. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
  4. 4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
  5. 5. Uncontrolled diabetes.
  6. 6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beonemed.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeOne Medicines

Study Locations (Sites)

Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90089-1019
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045-2517
United States
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, 32827-7400
United States
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, 21287
United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210-1240
United States

Collaborators and Investigators

Sponsor: BeOne Medicines

  • Study Director, STUDY_DIRECTOR, BeOne Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-12
Study Completion Date2028-05-15

Study Record Updates

Study Start Date2024-04-12
Study Completion Date2028-05-15

Terms related to this study

Keywords Provided by Researchers

  • BG-C9074
  • Tislelizumab
  • Advanced Solid Tumors
  • first-in-human
  • B7H4

Additional Relevant MeSH Terms

  • Advanced Solid Tumor