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Trial Title:
A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors
NCT ID:
NCT06625593
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
BG-C137
Advanced Solid Tumor
First-in-human
FGFR2b
ADC
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BG-C137
Description:
Administered intravenously
Arm group label:
Phase 1a: Dose Escalation and Safety Expansion
Arm group label:
Phase 1b: Dose Expansion
Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with
advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed advanced or metastatic solid tumors.
2. Life expectancy of ≥ 3 months.
3. Prior standard systemic therapy in the advanced or metastatic setting. Dose
Escalation: Participants for whom further standard treatment is not available, not
tolerated or determined not appropriate based on the investigator's judgment. Safety
Expansion and Dose Expansion: Participants who have received 1 or 2 prior lines of
systemic therapy in the advanced or metastatic setting.
4. Participants must provide agreement for collection of archival tissue or recently
obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and
other biomarker assessments.
5. ≥ 1 measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Adequate organ function as determined per protocol.
Exclusion Criteria:
1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate
(ADC) therapies or FGFR2b-targeted ADC therapies.
2. Active or chronic corneal disorder, history of corneal transplantation, corneal
keratitis, keratoconjuntivitis, keratopathy, corneal abrasion, inflammation or
ulceration, other active ocular conditions and any clinically significant corneal
disease that prevents adequate monitoring of drug-induced keratopathy.
3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated
brain metastasis.
4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days,
≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives [whichever is
shorter] for chemotherapy, ADCs, or investigational therapy) before first dose of
study drug(s).
5. Toxicities due to prior therapy that have not recovered.
6. Any malignancy ≤ 2 years before 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 curatively.
7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen
saturation at rest < 92%, or requirement for supplemental oxygen at baseline.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 20, 2024
Completion date:
December 31, 2026
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/NCT06625593
