DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Recruiting now · Phase 2
Conditions studied: Solid Tumors
In brief
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
Key facts
- Study ID
- NCT06953089
- Run by
- DualityBio Inc.
- People needed
- 450
- Starts
- 2025-07-18
- Expected to finish
- 2030-06-30
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- USA06-0 — Los Angeles, California, United States (enrolling)
- USA16-0 — Los Angeles, California, United States (enrolling)
- USA01-0 — Wheat Ridge, Colorado, United States (enrolling)
- USA08-0 — Florida City, Florida, United States (enrolling)
- USA10-0 — Atlanta, Georgia, United States (enrolling)
- USA11-0 — Bethesda, Maryland, United States (enrolling)
- USA14-0 — Lincoln, Nebraska, United States (enrolling)
- USA04-0 — New York, New York, United States (enrolling)
- USA15-0 — Portland, Oregon, United States (enrolling)
- USA03-0 — Charleston, South Carolina, United States (enrolling)
- USA13-0 — Anderson, Texas, United States (enrolling)
- USA12-0 — Houston, Texas, United States (enrolling)
- USA05-0 — Virginia Beach, Virginia, United States (enrolling)
- USA09-0 — Puyallup, Washington, United States (enrolling)
- USA07-0 — Spokane, Washington, United States (enrolling)
- AUS07-0 — North Sydney, New South Wales, Australia (enrolling)
- AUS06-0 — Benowa, Queensland, Australia (enrolling)
- AUS04-0 — Birtinya, Queensland, Australia (enrolling)
- AUS05-0 — Adelaide, South Australia, Australia (enrolling)
- CHN02-0 — Beijing, Beijing Municipality, China (enrolling)
- CHN13-0 — Beijing, Beijing Municipality, China (enrolling)
- CHN23-0 — Beijing, Beijing Municipality, China (enrolling)
- CHN17-0 — Dongguan, Guangdong, China (enrolling)
- CHN06-0 — Henan, Henan, China (enrolling)
- CHN12-0 — Xinxiang, Henan, China (enrolling)
Full record on ClinicalTrials.gov
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