Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
BGB-C354-101
Clinical summary
Summary
This study will be conducted in two 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 treamtent. The study duration is estimated to be approximately 5 years.
In Phase 1a Part A (Monotherapy Dose Escalation), a medicine called BGB-C354 (which is an antibody-drug conjugate) will be given by itself via intravenous (IV) infusion at sequentially increasing doses.
In Phase 1a Part B (safety Expansion), participants will enrol at safe dose levels of BGB-C354 (via IV infusion) recommended by the Safety Monitoring Committee (SMC) for further evaluation.
In Phase 1b Part C (Monotherapy Expansion), participants will receive BGB-C354 via IV infusion at the recommended dose for expansion (RDFE).
In Phase 1b Part D (Combination Therapy Expansion), participants will receive BGB-C354 and Tislelizumab immunotherapy at doses determined by the SMC, both administered by IV infusion.
Conditions
This trial is treating people with solid cancers that are advanced, metastatic, unable to be removed with surgery (unresectable) or not amenable to current curative treatment
Eligibility
Inclusion
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
- Adequate organ function.
- 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).
- 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).
Exclusion
- Prior treatment with B7H3-targeted therapy.
- 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).
- Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
- 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).
- History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
- 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).
- Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene
Scientific 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
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