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New drug targets Hard-to-Treat cancers in early trial

NCT ID NCT06625593

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called BG-C137, which delivers chemotherapy directly to cancer cells that have a specific marker (FGFR2b). The goal is to see if it is safe and can shrink tumors in people with advanced solid tumors who have run out of standard options. About 168 adults will take part, and the study will also test the drug in combination with other cancer treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    51 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Affiliated Hospital of Jiangnan University South Campus

    RECRUITING

    Wuxi, Jiangsu, 214122, China

  • Affiliated Zhongshan Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230000, China

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Cabrini Hospital Malvern

    RECRUITING

    Malvern, Victoria, VIC 3144, Australia

  • Cha Bundang Medical Center, Cha University

    RECRUITING

    BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-4433, United States

  • Fudan University Shanghai Cancer Centerpudong

    RECRUITING

    Shanghai, Shanghai Municipality, 201321, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Gachon University Gil Medical Center

    RECRUITING

    NamdongGu, Incheon Gwang'yeogsi, 21565, South Korea

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06273, South Korea

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    RECRUITING

    Nanning, Guangxi, 530201, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Heping Hospital Affiliated to Changzhi Medical College

    RECRUITING

    Changzhi, Shanxi, 046000, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Icon Cancer Centre South Brisbane

    RECRUITING

    South Brisbane, Queensland, QLD 4101, Australia

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    BukGu, Gyeongsangbukdo, 41404, South Korea

  • Liaoning Cancer Hospital and Institute

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, NSW 2170, Australia

  • Mayo Clinic Rochester

    COMPLETED

    Rochester, Minnesota, 55905-0001, United States

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-3907, United States

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

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

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

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

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, Sichuan, 610071, China

  • The Affiliated Hospital of Qingdao University Branch North

    RECRUITING

    Qingdao, Shandong, 266000, China

  • The Affiliated Hospital of Xuzhou Medical University Kunpeng Road Branch

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Xinxiang, Henan, 453100, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of Shandong First Medical University

    RECRUITING

    Taian, Shandong, 271099, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230601, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792-0001, United States

  • Usc Norris Comprehensive Cancer Center (Nccc)

    RECRUITING

    Los Angeles, California, 90089-1019, United States

  • Weifang Peoples Hospital Beichen Branch

    RECRUITING

    Weifang, Shandong, 261057, China

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

  • Zhongshan Hospital Xiamen University

    RECRUITING

    Xiamen, Fujian, 361004, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.