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NCT06625593PHASE1Recruiting

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

BeOne Medicines

Start Date

12/9/2024

Completion Date

12/31/2026

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).

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BG-C137

DRUG

Anticancer Agents

Interested in This Trial?

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Conditions

Advanced Solid Tumor

Locations

Usc Norris Comprehensive Cancer Center (Nccc)

Los Angeles, California 90089-1019

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905-0001

United States

Md Anderson Cancer Center

Houston, Texas 77030-3907

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington 98109-4433

United States

University of Wisconsin

Madison, Wisconsin 53792-0001

United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales NSW 2148

Australia

Liverpool Hospital

Liverpool, New South Wales NSW 2170

Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland QLD 4101

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

Cabrini Hospital Malvern

Malvern, Victoria VIC 3144

Australia

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui 233004

China

Anhui Provincial Hospital

Hefei, Anhui 230000

China

The Second Hospital of Anhui Medical University

Hefei, Anhui 230601

China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality 100050

China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142

China

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian 361003

China

Zhongshan Hospital Xiamen University

Xiamen, Fujian 361004

China

Guangxi Medical University Cancer Hospital Wuxiang Branch

Nanning, Guangxi 530201

China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei 050011

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan 471003

China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan 453100

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

Hubei Cancer Hospital

Wuhan, Hubei 430079

China

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

Nanjing, Jiangsu 210008

China

Jiangsu Province Hospital

Nanjing, Jiangsu 210029

China

Affiliated Hospital of Jiangnan University South Campus

Wuxi, Jiangsu 214122

China

The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch

Xuzhou, Jiangsu 221000

China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning 110042

China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi 710061

China

Shandong Cancer Hospital

Jinan, Shandong 250117

China

The Affiliated Hospital of Qingdao University Branch North

Qingdao, Shandong 266000

China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong 271099

China

Weifang Peoples Hospital Beichen Branch

Weifang, Shandong 261057

China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality 200032

China

Fudan University Shanghai Cancer Centerpudong

Shanghai, Shanghai Municipality 201321

China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi 046000

China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi 030013

China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan 610071

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310022

China

Cha Bundang Medical Center, Cha University

BundangGu SeongnamSi, Gyeonggi-do 13496

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Kyungpook National University Chilgok Hospital

BukGu, Gyeongsangbukdo 41404

South Korea

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'yeogsi 21565

South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi 03080

South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, Seoul Teugbyeolsi 06273

South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi 05505

South Korea