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NCT06625593

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

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Reclutando Fase 1

Descripción

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).

Criterios de Elegibilidad

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.

Información del Ensayo

NCT06625593
Reclutando
Fase 1
168 participantes
Dic 2024
Dic 2026

Ubicaciones53

Australia (5)
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148 Reclutando
Liverpool Hospital
Liverpool, New South Wales, NSW 2170 Reclutando
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, QLD 4101 Reclutando
Monash Health
Clayton, Victoria, VIC 3168 Reclutando
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144 Reclutando
China (33)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004 Reclutando
Anhui Provincial Hospital
Hefei, Anhui, 230000 Reclutando
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601 Reclutando
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142 Reclutando
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050 Reclutando
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001 Reclutando
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003 Reclutando
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004 Reclutando
The Tumor Hospital Affiliated to Guangxi Medical Universitywuxiang Branch
Nanning, Guangxi, 530201 Reclutando
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011 Reclutando
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000 Reclutando
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003 Reclutando
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100 Reclutando
Henan Cancer Hospital
Zhengzhou, Henan, 450000 Reclutando
Hubei Cancer Hospital
Wuhan, Hubei, 430079 Reclutando
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029 Reclutando
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008 Reclutando
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, 214122 Reclutando
The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch
Xuzhou, Jiangsu, 221000 Reclutando
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042 Reclutando
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061 Reclutando
Shandong Cancer Hospital
Jinan, Shandong, 250117 Reclutando
The Affiliated Hospital of Qingdao University Branch North
Qingdao, Shandong, 266000 Reclutando
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271099 Reclutando
Weifang Peoples Hospital Beichen Branch
Weifang, Shandong, 261057 Reclutando
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032 Reclutando
Fudan University Shanghai Cancer Centerpudong
Shanghai, Shanghai Municipality, 201321 Reclutando
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, 200123 Reclutando
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000 Reclutando
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013 Reclutando
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071 Reclutando
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060 Reclutando
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022 Reclutando
South Korea (9)
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, 13496 Reclutando
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620 Reclutando
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, 41404 Reclutando
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, 21565 Reclutando
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351 Reclutando
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722 Reclutando
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 06273 Reclutando
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080 Reclutando
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505 Reclutando
United States (6)
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, 90089-1019 Reclutando
Yale Cancer Center
New Haven, Connecticut, 06510 Reclutando
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001 Completado
Md Anderson Cancer Center
Houston, Texas, 77030-3907 Reclutando
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433 Reclutando
University of Wisconsin
Madison, Wisconsin, 53792-0001 Reclutando