Clinical trial NCT06598800: Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Advanced Solid Tumors
First-in-human
BG-T187
EGFR
c-MET
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Patients must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
5. ≥ 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.
6. Adequate organ function.

Exclusion Criteria:

1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.
2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.
3. 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).
4. 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.
5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).
6. Active hepatitis C.
7. 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.

Primary outcomes:
measure: Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 2 years
measure: Phase 1a: Maximum Administered Dose (MAD) of BG-T187
timeFrame: Approximately 2 years
measure: Phase 1a: Maximum Tolerated Dose (MTD) of BG-T187
timeFrame: Approximately 2 years
measure: Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187
timeFrame: Approximately 2 years
measure: Phase 1b: Overall Response Rate (ORR)
timeFrame: Approximately 2 years
measure: Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Phase 1a: ORR
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Duration of Response (DOR)
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Disease Control Rate (DCR)
timeFrame: Approximately 2 years
measure: Phase 1b: Progression Free Survival (PFS)
timeFrame: Approximately 2 years
measure: Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-T187
timeFrame: From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
measure: Phase 1a and 1b: Area Under the Plasma Concentration-time Curve (AUC) of BG-T187
timeFrame: From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
measure: Phase 1a and 1b: Terminal Half-Life (t1/2) of BG-T187
timeFrame: From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
measure: Phase 1a and 1b: Time to maximum plasma concentration (Tmax) of BG-T187
timeFrame: From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
measure: Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BG-T187
timeFrame: From Cycle 1 Day 1 up to Cycle19 Day1 (each cycle is 28 days)
measure: Phase 1b: Number of Participants with AEs and SAEs
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Next Virginia
state: Virginia
city: Madison
country: United States
facility: Washington University, St Louis, Division of Oncology
state: Wisconsin
city: Blacktown
country: Australia
facility: Blacktown Cancer and Haematology Centre
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Malvern East
country: Australia
facility: Cabrini Hospital Malvern
state: Victoria
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat Sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: