DB-1311 plus BNT327 or DB-1305 for advanced solid tumors
Official title: A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors
Run by DualityBio Inc. · NCT06953089 · Data updated 2026-11-12
This trial tests whether combining the experimental drug DB-1311 with BNT327 or with DB-1305 can help adults with advanced or metastatic solid tumors such as HCC, cervical cancer, melanoma, head and neck cancer, platinum-resistant ovarian cancer, or non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | DualityBio Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 37 sites (Los Angeles, California and 36 other locations) |
| Status | Recruiting |
| Started | July 18, 2025 |
| Main results expected | June 30, 2030 |
| Study ends | June 30, 2030 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06953089 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced or metastatic HCC, cervical cancer, melanoma, head and neck squamous cell carcinoma, platinum-resistant ovarian cancer, or NSCLC who have at least one measurable lesion, ECOG 0–1, adequate organ function, appropriate washout from prior therapies, and life expectancy ≥3 months are the intended participants.
✕Probably not a fit
Patients with poor performance status (ECOG >1), inadequate organ function, Child-Pugh B/C liver disease for HCC, or who cannot comply with washout or site visit requirements are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase II, multicenter, open-label, two-part trial testing DB-1311 in combination with either BNT327 or DB-1305 in patients with various advanced or metastatic solid tumors. Participants must have measurable disease by RECIST v1.1, ECOG performance status 0–1, adequate organ function, and a life expectancy of at least three months, with disease-specific requirements such as Child-Pugh A for HCC. The study will administer the combination regimens and monitor safety, tolerability, and preliminary anti-tumor activity. Outcomes will include adverse events and objective response measures to determine whether further development is warranted.
Why it matters
Potential benefit: If successful, the combinations could shrink tumors or slow disease progression in patients with advanced solid tumors who have limited treatment options.
How similar studies have gone: Related antibody-drug conjugates and combinations targeting B7-H3, PD-L1/VEGF-A, or TROP2 have shown early activity in some cancers, but the specific DB-1311 plus BNT327 or DB-1305 combinations are novel and not yet proven in late-stage trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key 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 CC with squamous cell, adenocarcinoma, or adenosquamous histology
* For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic/stage IV melanoma.
* For PROC patients (Part 1, Cohort 1A): 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 (Part 2 Arm 6 only): 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 (Part 2 Arm 7 only): Participants with advanced/unresectable metastatic PDAC without AGA who have progressed after only one prior line of standard systemic treatments (2L PDAC without AGA), or participants with AGA who have progressed on or after at least one and a maximum of two prior lines of standard systemic treatment (2L-3L PDAC with AGA).
* For breast cancer (Part 2 Arm 8 only):
* 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 (Part 2 Arm 9 only): Participants with advanced/unresectable mCRC without AGA who have progressed after only one prior line of standard systemic treatment (2L mCRC without AGA), or participants with AGA who have progressed on or after at least one and a maximum of two prior lines of standard systemic treatment (2L-3L mCRC with AGA).
* For mCRPC (Part 2 Arm 10 only): Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC
Key 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.
* Other protocol defined inclusion and exclusion criteria apply.
Where it's running
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Usa06-0
Los Angeles, California, United States Recruiting -
Usa16-0
Los Angeles, California, United States Recruiting -
Usa01-0
Wheat Ridge, Colorado, United States Recruiting -
Usa08-0
Florida City, Florida, United States Recruiting -
Usa10-0
Atlanta, Georgia, United States Recruiting -
Usa11-0
Bethesda, Maryland, United States Recruiting
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Usa14-0
Lincoln, Nebraska, United States Recruiting -
Usa04-0
New York, New York, United States Recruiting -
Usa15-0
Portland, Oregon, United States Recruiting -
Usa03-0
Charleston, South Carolina, United States Recruiting -
Usa13-0
Anderson, Texas, United States Recruiting -
Usa12-0
Houston, Texas, United States Recruiting -
Usa05-0
Virginia Beach, Virginia, United States Recruiting -
Usa09-0
Puyallup, Washington, United States Recruiting -
Usa07-0
Spokane, Washington, United States Recruiting -
Aus07-0
North Sydney, New South Wales, Australia Recruiting -
Aus06-0
Benowa, Queensland, Australia Recruiting -
Aus04-0
Birtinya, Queensland, Australia Recruiting -
Aus05-0
Adelaide, South Australia, Australia Recruiting -
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Beijing, Beijing Municipality, China Recruiting -
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Beijing, Beijing Municipality, China Recruiting -
Chn23-0
Beijing, Beijing Municipality, China Recruiting -
Chn17-0
Dongguan, Guangdong, China Recruiting -
Chn06-0
Henan, Henan, China Recruiting -
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Xinxiang, Henan, China Recruiting -
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Hubei, Hubei, China Recruiting -
Chn26-0
Wuhan, Hubei, China Recruiting -
Chn34-0
Wuhan, Hubei, China Recruiting -
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Changsha, Hunan, China Recruiting -
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Xuzhou, Jiangsu, China Recruiting -
Chn35-0
Shenyang, Liaoning, China Recruiting -
Chn25-0
Xi'an, Shaanxi, China Recruiting -
Chn04-0
Shanghai, Shanghai Municipality, China Recruiting -
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Shanghai, Shanghai Municipality, China Recruiting -
Chn24-0
Chengdu, Sichuan, China Recruiting -
Twn01-0
Taipei, Taipei, Taiwan Recruiting -
Twn02-0
Taipei, Taipei, Taiwan Recruiting
Study contacts
- Study coordinator: Jay Ma
- Email: jay.ma@dualitybiologics.com
- Phone: 540-808-3925
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.