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

NCT06625593 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: BG-C137-1012025-523572-23-00CTR20244835
• Study Type: interventional
• Target: 168
• Locations: 4 countries
• Sites: 52

Brief 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).

Conditions

Advanced Solid Tumor

Keywords

BG-C137; Advanced Solid Tumor; First-in-human; FGFR2b; ADC; Fibroblast growth factor receptor 2b

Outcome Measures

Primary Outcomes (5)

• 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: 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 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

• 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

Secondary Outcomes (13)

• Phase 1a: ORR

  Up to approximately 2 years

• Phase 1a and 1b: Disease Control Rate (DCR)

  Up to approximately 2 years

• Phase 1a and 1b: Duration of Response (DOR)

  Up to approximately 2 years

• Phase 1b: Progression Free Survival (PFS)

  Up to approximately 2 years

• Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to approximately 2 years

Study Arms (3)

Phase 1a: Monotherapy Dose Escalation and Safety Expansion

EXPERIMENTAL

Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy

Drug: BG-C137

Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion

EXPERIMENTAL

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; Drug: Anticancer Agents

Phase 1b: Dose Expansion

EXPERIMENTAL

Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications

Drug: BG-C137

Interventions

BG-C137 DRUG

Administered intravenously

Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion; Phase 1a: Monotherapy Dose Escalation and Safety Expansion; Phase 1b: Dose Expansion

Anticancer Agents DRUG

Administered intravenously or orally

Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced or metastatic solid tumors.
• Life expectancy of ≥ 3 months.
• 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
• 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.
• ≥ 1 measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate organ function as determined per protocol.

You may not qualify if:

• Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
• 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.
• Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• 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).
• Toxicities due to prior therapy that have not recovered.
• 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.
• History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline.

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (52)

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California, 90089-1019, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905-0001, United States

COMPLETED

Md Anderson Cancer Center

Houston, Texas, 77030-3907, United States

RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-4433, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53792-0001, United States

RECRUITING

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

RECRUITING

Liverpool Hospital

Liverpool, New South Wales, NSW 2170, Australia

RECRUITING

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, QLD 4101, Australia

RECRUITING

Monash Health

Clayton, Victoria, VIC 3168, Australia

RECRUITING

Cabrini Hospital Malvern

Malvern East, Victoria, VIC 3144, Australia

RECRUITING

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

RECRUITING

The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch

Nanning, Guangxi, 530201, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu, 214122, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch

Xuzhou, Jiangsu, 221000, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

RECRUITING

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

The Affiliated Hospital of Qingdao University Branch North

Qingdao, Shandong, 266000, China

RECRUITING

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, 271099, China

RECRUITING

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong, 261057, China

RECRUITING

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 046000, China

RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013, China

RECRUITING

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, 610071, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital

BukGu, Gyeongsangbukdo, 41404, South Korea

RECRUITING

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi, 21565, South Korea

RECRUITING

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 06273, South Korea

RECRUITING

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

Antineoplastic Agents

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 3, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

AU (5); KR (9); US (6); CN (32)