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

A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors

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).

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: BG-C137; Drug: Anticancer Agents

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Cancer and Haematology Centre
    • Liverpool, New South Wales, Australia, NSW 2170
      • Recruiting
      • Liverpool Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, QLD 4101
      • Recruiting
      • Icon Cancer Centre South Brisbane
  • Victoria
    • Clayton, Victoria, Australia, VIC 3168
      • Recruiting
      • Monash Health
    • Malvern East, Victoria, Australia, VIC 3144
      • Recruiting
      • Cabrini Hospital Malvern
• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical University
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230601
      • Recruiting
      • The Second Hospital of Anhui Medical University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
    • Xiamen, Fujian, China, 361004
      • Recruiting
      • Zhongshan Hospital Xiamen University
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • Recruiting
      • The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Luoyang, Henan, China, 471003
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science And Technology
    • Xinxiang, Henan, China, 453100
      • Recruiting
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
    • Wuxi, Jiangsu, China, 214122
      • Recruiting
      • Affiliated Hospital of Jiangnan University South Campus
    • Xuzhou, Jiangsu, China, 221000
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital and Institute
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xian Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • The Affiliated Hospital of Qingdao University Branch North
    • Taian, Shandong, China, 271099
      • Recruiting
      • The Second Affiliated Hospital of Shandong First Medical University
    • Weifang, Shandong, China, 261057
      • Recruiting
      • Weifang Peoples Hospital Beichen Branch
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Affiliated Zhongshan Hospital of Fudan University
    • Shanghai, Shanghai Municipality, China, 200123
      • Recruiting
      • Shanghai East Hospital Branch Hospital
    • Shanghai, Shanghai Municipality, China, 201321
      • Recruiting
      • Fudan University Shanghai Cancer Centerpudong
  • Shanxi
    • Changzhi, Shanxi, China, 046000
      • Recruiting
      • Heping Hospital Affiliated to Changzhi Medical College
    • Taiyuan, Shanxi, China, 030013
      • Recruiting
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610071
      • Recruiting
      • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
• South Korea
  • Gyeonggi-do
    • BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13496
      • Recruiting
      • CHA Bundang Medical Center, CHA University
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Gyeongsangbukdo
    • BukGu, Gyeongsangbukdo, South Korea, 41404
      • Recruiting
      • Kyungpook National University Chilgok Hospital
  • Incheon Gwang'yeogsi
    • NamdongGu, Incheon Gwang'yeogsi, South Korea, 21565
      • Recruiting
      • Gachon University Gil Medical Center
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • Seoul, Seoul Teugbyeolsi, South Korea, 06273
      • Recruiting
      • Gangnam Severance Hospital, Yonsei University Health System
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center
• United States
  • California
    • Los Angeles, California, United States, 90089-1019
      • Recruiting
      • Usc Norris Comprehensive Cancer Center (Nccc)
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale Cancer Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Completed
      • Mayo Clinic Rochester
  • Texas
    • Houston, Texas, United States, 77030-3907
      • Recruiting
      • MD Anderson Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109-4433
      • Recruiting
      • Fred Hutchinson Cancer Research Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • Recruiting
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1b: Dose Expansion; Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications	Drug: BG-C137; Administered intravenously
Experimental: Phase 1a: Monotherapy Dose Escalation and Safety Expansion; Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy	Drug: BG-C137; Administered intravenously
Experimental: Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion; Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation	Drug: BG-C137; Administered intravenously; Drug: Anticancer Agents; Administered intravenously or orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137	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.	Up to approximately 2 years
Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137	The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available	Up to approximately 2 years
Phase 1b: Overall Response Rate (ORR)	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)	Up to approximately 2 years
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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)	Up to approximately 2 years
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agents	RDFE(s) is determined based on relevant data, as available	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: ORR	ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1	Up to approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by RECIST v1.1	Up to approximately 2 years
Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever comes first, as assessed using RECIST v1.1	Up to approximately 2 years
Phase 1b: Progression Free Survival (PFS)	PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed using RECIST v1.1 or death, whichever occurs first	Up to approximately 2 years
Phase 1a: Plasma concentrations of BG-C137 analytes		Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)
Phase 1b: Plasma concentrations of BGB-C137 analytes		Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose)
Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-C137 analytes		Twice in the first 3 months
Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-C137 analytes		Twice in the first 3 months
Phase 1a: Minimum Observed Plasma Concentration (Ctrough) Of BGB-C137 analytes		Twice in the first 3 months
Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BGB-C137 analytes		Twice in the first 3 months
Phase 1a: Terminal Half-Life (t1/2) of BGB-C137 analytes		Twice in the first 3 months
Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-C137		Up to approximately 2 years
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	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), and AEs meeting protocol-defined adverse event of clinical interest (AECI)s.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Advanced Solid Tumor; ADC; First-in-human; FGFR2b; BG-C137; Fibroblast growth factor receptor 2b
• Additional Relevant MeSH Terms: Neoplasms; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Antineoplastic Agents
• Other Study ID Numbers: BG-C137-101; 2025-523572-23-00 (Ctis); CTR20244835 (Other Identifier: ChinaTrialDrugs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No