RECRUITING

A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

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, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years. * The study duration is estimated to be approximately 5 years.

Official Title

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2024-07-08
Study Completion:2027-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06422520

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 of 0 or 1.
  3. 3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
  4. 4. ≥ 1 measurable lesion per RECIST v1.1.
  5. 5. Able to provide an archived tumor tissue sample.
  6. 6. Adequate 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 B7H3-targeted therapy.
  2. 2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
  3. 3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
  4. 4. 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).
  5. 5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline
  6. 6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s).
  7. 7. 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@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, 32827-7400
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110-1010
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Next Oncology
San Antonio, Texas, 78229-6028
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

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 Date2024-07-08
Study Completion Date2027-01-31

Study Record Updates

Study Start Date2024-07-08
Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

  • BGB-C354
  • Tislelizumab
  • First-in-human
  • Advanced solid tumor
  • Anti-PD-1 Monoclonal Antibody
  • B7H3
  • antibody drug conjugate

Additional Relevant MeSH Terms

  • Advanced Solid Tumor