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New hope for advanced cancer: combo therapy trial launches

NCT ID NCT06953089

Disease control Sponsor: DualityBio Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests two new drug combinations (DB-1311 with BNT327 or DB-1305) in 450 adults with advanced or metastatic solid tumors that have not responded to other treatments. The main goals are to check safety and see if tumors shrink. Participants must be in fairly good health and have at least one measurable tumor.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 450 people

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

Started

Jul 2025

Expected to finish

Jun 2030

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: * Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent. * At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria. * Has a life expectancy of ≥ 3 months. * Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 * Has adequate organ function within 7 days prior to enrollment/randomization, * Has adequate treatment washout period prior to the first dose of trial treatment. * For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score. * For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology * For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma. * For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease. * For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local/ or systemic therapies)/ (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. * For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC. Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations * For PSOC: Must have PSOC, defined as radiographically documented disease recurrence or progression occurring \>6 months after completion of the last dose of platinum-based chemotherapy. * For PDAC: Participants must have histologically or cytologically confirmed metastatic PDAC., who have progressed after at least one prior line of standard systemic treatment ((≥2L PDAC).) * For breast cancer: * HR+/HER2-low or HR+/HER2-ultralow or HR+/HER2-negative BC participants: Pathologically or cytologically documented HR-positive unresectable or metastatic BC with HER2-low, HER2-ultralow or HER2-negative expression. * Triple negative breast cancer (TNBC): Pathologically or cytologically documented unresectable or metastatic TNBC * For mCRC: Participants who have metastatic CRC and have relapsed or progressed after 1 prior line of systemic treatment including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or have relapsed or progressed after 2 lines of therapy if the participant has received targeted therapy * For mCRPC: Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC Exclusion Criteria: * 1\. Prior treatment with B7H3 targeted therapy. * Prior treatment with antibody-drug conjugate with topoisomerase inhibitor. * Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment. * Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs. * Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy. * Has a history of (non-infectious) ILD/pneumonitis. * Any autoimmune, connective tissue or inflammatory disorders. * Has spinal cord compression or clinically active central nervous system (CNS) metastases. * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.

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Conditions

The condition(s) this trial relates to.

breast cancer cervical cancer colorectal cancer head and neck squamous cell carcinoma hepatocellular carcinoma melanoma metastatic prostate carcinoma non-small cell lung carcinoma ovarian cancer ovarian carcinoma pancreatic ductal adenocarcinoma refractory malignant neoplasm Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Solid tumors

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • AUS04-0

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • AUS05-0

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • AUS06-0

    RECRUITING

    Benowa, Queensland, 4217, Australia

  • AUS07-0

    RECRUITING

    North Sydney, New South Wales, 2060, Australia

  • CHN01-0

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • CHN02-0

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • CHN04-0

    RECRUITING

    Hubei, Hubei, 430014, China

  • CHN04-0

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • CHN06-0

    RECRUITING

    Henan, Henan, 450008, China

  • CHN11-0

    RECRUITING

    Changsha, Hunan, 410013, China

  • CHN12-0

    RECRUITING

    Xinxiang, Henan, 453100, China

  • CHN13-0

    RECRUITING

    Beijing, Beijing Municipality, 100032, China

  • CHN16-0

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • CHN17-0

    RECRUITING

    Dongguan, Guangdong, 523000, China

  • CHN23-0

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • CHN24-0

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • CHN25-0

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • CHN26-0

    RECRUITING

    Wuhan, Hubei, 00000, China

  • CHN34-0

    RECRUITING

    Wuhan, Hubei, 430079, China

  • CHN35-0

    RECRUITING

    Shenyang, Liaoning, 110042, China

  • TWN01-0

    RECRUITING

    Taipei, Taipei, 0, Taiwan

  • TWN02-0

    RECRUITING

    Taipei, Taipei, 23561, Taiwan

  • USA01-0

    RECRUITING

    Wheat Ridge, Colorado, 80033, United States

  • USA03-0

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • USA04-0

    RECRUITING

    New York, New York, 10032, United States

  • USA05-0

    RECRUITING

    Virginia Beach, Virginia, 22031, United States

  • USA06-0

    RECRUITING

    Los Angeles, California, 90025, United States

  • USA07-0

    RECRUITING

    Spokane, Washington, 99208, United States

  • USA08-0

    RECRUITING

    Florida City, Florida, 99208, United States

  • USA09-0

    RECRUITING

    Puyallup, Washington, 98373, United States

  • USA10-0

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • USA11-0

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • USA12-0

    RECRUITING

    Houston, Texas, 77030, United States

  • USA13-0

    RECRUITING

    Anderson, Texas, 46011, United States

  • USA14-0

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • USA15-0

    RECRUITING

    Portland, Oregon, 97239, United States

  • USA16-0

    RECRUITING

    Los Angeles, California, 90025, United States

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