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Trial Title:
Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors
NCT ID:
NCT06598800
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced Solid Tumors
First-in-human
BG-T187
EGFR
c-MET
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Drug: BG-T187
Description:
Intravenous administration
Arm group label:
Phase 1a: Part A: Monotherapy Dose Escalation
Arm group label:
Phase 1a: Part B: Monotherapy Safety Expansion
Arm group label:
Phase 1b: Monotherapy Dose Expansion
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Blacktown Cancer and Haematology Centre
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Start date:
October 18, 2024
Completion date:
January 31, 2028
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598800
