Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Registration Number
- NCT06598800
- Lead Sponsor
- BeiGene
- Brief Summary
This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Patients must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
- ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.
- Adequate organ function.
- Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
- Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
- Any malignancy ≤ 3 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 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 ILD or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD/noninfectious pneumonitis, or where suspected ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
- Active hepatitis C.
- Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents Approximately 2 years R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Approximately 2 years Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome \[CRS\] and immune effector cell associated neurotoxicity syndrome \[ICANS\]); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1a: Maximum Administered Dose (MAD) of BG-T187 Approximately 2 years MAD is defined as the highest dose that can be administered safely and tolerably
Phase 1a: Maximum Tolerated Dose (MTD) of BG-T187 Approximately 2 years MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187 Approximately 2 years RDFE(s) is determined based on the MAD or MTD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available
Phase 1b: Overall Response Rate (ORR) Approximately 2 years ORR is defined as the percentage of participants with confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Secondary Outcome Measures
Name Time Method Phase 1a and 1b: Terminal Half-Life (t1/2) of BG-T187 From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days) Phase 1a: ORR Approximately 2 years ORR is defined as the percentage of participants with confirmed BOR, CR or PR as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Phase 1a and 1b: Duration of Response (DOR) Approximately 2 years DOR is defined as the time from the first objective response until the first documentation of disease progression after treatment initiation or death, whichever comes first, as determined by investigators per RECIST v1.1
Phase 1a and 1b: Disease Control Rate (DCR) Approximately 2 years DCR is defined as the proportion of participants with the BOR of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1
Phase 1b: Progression Free Survival (PFS) Approximately 2 years PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-T187 From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days) Phase 1a and 1b: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187 From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days) Phase 1a and 1b: Time to maximum plasma concentration (Tmax) of BG-T187 From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days) Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BG-T187 From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days) Phase 1b: Number of Participants with AEs and SAEs Approximately 2 years Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT)
Trial Locations
- Locations (19)
Guangxi Medical University Cancer Hospital
🇨🇳Nanning, Guangxi, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
The University of Texas Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
Next Virginia
🇺🇸Fairfax, Virginia, United States
Washington University, St Louis, Division of Oncology
🇺🇸Madison, Wisconsin, United States
Blacktown Cancer and Haematology Centre
🇦🇺Blacktown, New South Wales, Australia
Macquarie University
🇦🇺North Ryde, New South Wales, Australia
Cabrini Hospital Malvern
🇦🇺Malvern East, Victoria, Australia
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The Sixth Affiliated Hospital, Sun Yat Sen University
🇨🇳Guangzhou, Guangdong, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China