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DB-1311 plus BNT327 or DB-1305 for advanced solid tumors

A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors

PHASE2 · DualityBio Inc. · NCT06953089

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

PhasePHASE2
Study typeInterventional
Enrollment492 (estimated)
Ages18 Years and up
SexAll
SponsorDualityBio Inc. (industry)
Locations37 sites (Los Angeles, California and 36 other locations)
Trial IDNCT06953089 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

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.

Where this trial is running

Los Angeles, California and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Solid Tumors, B7-H3, PD-L1/VEGF-A, TROP2, ADC, HNSCC, HCC, Melanoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.