A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid Tumors
Anticancer Agents: Administered intravenously or orally
Study summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation and Safety Expansion) and Phase 1b (Dose Expansion).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and/or a platinum in the advanced or metastatic setting
4. Tumors with FGFR2b expression/ or FGFR2 gene amplification. 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, keratoconjunctivitis, 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.
Primary outcome measure(s)
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to approximately 2 years Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137 — Up to approximately 2 years The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively.
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agents — Up to approximately 2 years RDFE(s) is determined based on relevant data, as available
Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137 — Up to approximately 2 years The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available
Phase 1b: Overall Response Rate (ORR) — Up to approximately 2 years ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Trial sites (52)
Facility
City
Region
Status
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles
California
Recruiting
Yale Cancer Center
New Haven
Connecticut
Recruiting
Mayo Clinic Rochester
Rochester
Minnesota
Completed
Md Anderson Cancer Center
Houston
Texas
Recruiting
Fred Hutchinson Cancer Research Center
Seattle
Washington
Recruiting
University of Wisconsin
Madison
Wisconsin
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown
New South Wales
Recruiting
Liverpool Hospital
Liverpool
New South Wales
Recruiting
Icon Cancer Centre South Brisbane
South Brisbane
Queensland
Recruiting
Monash Health
Clayton
Victoria
Recruiting
Cabrini Hospital Malvern
Malvern
Victoria
Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Anhui
Recruiting
Anhui Provincial Hospital
Hefei
Anhui
Recruiting
The Second Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Fujian Medical University Union Hospital
Fuzhou
Fujian
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
Zhongshan Hospital Xiamen University
Xiamen
Fujian
Recruiting
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning
Guangxi
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
Henan
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
Henan
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
Affiliated Hospital of Jiangnan University South Campus
Wuxi
Jiangsu
Recruiting
The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch
Xuzhou
Jiangsu
Recruiting
Liaoning Cancer Hospital and Institute
Shenyang
Liaoning
Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an
Shaanxi
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
The Affiliated Hospital of Qingdao University Branch North
Qingdao
Shandong
Recruiting
The Second Affiliated Hospital of Shandong First Medical University
Taian
Shandong
Recruiting
Weifang Peoples Hospital Beichen Branch
Weifang
Shandong
Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
Fudan University Shanghai Cancer Centerpudong
Shanghai
Shanghai Municipality
Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi
Shanxi
Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan
Shanxi
Recruiting
+ 12 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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