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New targeted drug shows promise for Hard-to-Treat cancers

NCT ID NCT06233942

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug called BG-C9074, designed to target and kill cancer cells in people with advanced solid tumors that have not responded to standard treatments. The study will first find the safest dose, then test it alone or with other cancer drugs. About 308 adults with various advanced cancers will participate to see if the drug is safe and effective.

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 308 people

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

Started

Apr 2024

Expected to finish

May 2028

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. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy and whose cancer is not amenable to therapy with curative intent, and for whom further treatment is not available or not tolerated. Enrollment will be limited to participants with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer. 4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) 5. Able to provide an archived tumor tissue sample. 6. Adequate bone marrow and organ function. 7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s). 8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s). Exclusion Criteria: 1. Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload. 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 3. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline. 5. Uncontrolled diabetes. 6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma endometrial cancer hormone receptor-positive breast cancer non-small cell squamous lung carcinoma ovarian cancer triple-negative breast carcinoma

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

    33 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 Jining Medical University

    RECRUITING

    Jining, Shandong, 272000, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Cabrini Hospital Malvern

    RECRUITING

    Malvern, Victoria, VIC 3144, Australia

  • Cancer Care Wollongong

    RECRUITING

    Wollongong, New South Wales, NSW 2500, Australia

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer Institute Hospital of Jfcr

    ACTIVE_NOT_RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria

    RECRUITING

    São Paulo, 01318-001, Brazil

  • Florida Cancer Specialist Research Institute Lake Nona

    RECRUITING

    Orlando, Florida, 32827-7400, United States

  • Fujian Cancer Hospital

    ACTIVE_NOT_RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Hospital Sao Lucas Da Pucrs

    RECRUITING

    Porto Alegre, 90610-000, Brazil

  • Hospital Sirio Libanes Brasilia

    RECRUITING

    Brasília, 70200-730, Brazil

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Instituto Nacional de Cancer Hospital Do Cancer Ii

    RECRUITING

    Rio de Janerio, 20220-410, Brazil

  • James Cancer Hospital and Solove Research Institute

    RECRUITING

    Columbus, Ohio, 43210-1240, United States

  • Liaoning Cancer Hospital and Institute

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • Liga Norte Riograndene Contra O Cancer

    RECRUITING

    Natal, 59062-000, Brazil

  • Linear Clinical Research

    COMPLETED

    Nedlands, Western Australia, WA 6009, Australia

  • Macquarie University

    RECRUITING

    North Ryde, New South Wales, NSW 2109, Australia

  • Monash Health

    RECRUITING

    Clayton, Victoria, VIC 3168, Australia

  • National Cancer Center Hospital East

    ACTIVE_NOT_RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Obstetrics and Gynecology Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200011, China

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, VIC 3000, Australia

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, QLD 4102, Australia

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250000, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110004, China

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The Second Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116023, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045-2517, United States

  • Usc Norris Comprehensive Cancer Center (Nccc)

    RECRUITING

    Los Angeles, California, 90089-1019, United States

  • Weifang Peoples Hospital

    RECRUITING

    Weifang, Shandong, 261000, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

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