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

NCT ID NCT06422520

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called BGB-C354, alone or with an immunotherapy (tislelizumab), in 63 people with advanced solid tumors that had not responded to standard treatments. The main goals were to check safety and find the right dose. Researchers also looked for signs that the tumors shrank. The study is complete, but results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-C354 (an antibody-drug conjugate) and tislelizumab (an immunotherapy)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early, first-in-human study with only 63 participants. The drug may not shrink tumors or could cause serious side effects. Success in this small trial does not guarantee it will work in larger studies.

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

63 people

The number who actually took part.

Started

Jul 2024

Finished

May 2026

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 of 0 or 1. 3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent: 4. ≥ 1 measurable lesion per RECIST v1.1. 5. Able to provide an archived tumor tissue sample. 6. Adequate 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 B7H3-targeted therapy. 2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts). 3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis 4. 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). 5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline 6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s). 7. 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.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418, United States

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando, Florida, 32827-7400, United States

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Next Oncology

    San Antonio, Texas, 78229-6028, United States

  • One Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065, Australia

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004, Australia

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital

    Westmead, New South Wales, NSW 2145, Australia

More trials for these conditions

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