DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors (NCT06953089)

🧪 Interventions in This Study

• DB-1311/BNT324 (DRUG)
• BNT327 (DRUG)
• DB-1305/BNT325 (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
2. At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
3. Has a life expectancy of ≥ 3 months.
4. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
5. Has adequate organ function within 7 days prior to enrollment/randomization,
6. Has adequate treatment washout period prior to the first dose of trial treatment.
7. For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.
8. For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology
9. For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
10. 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.
11. 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.
12. 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (37 Sites)

Showing the first 25 of 37 sites.

• USA06-0 — Los Angeles, California
• USA16-0 — Los Angeles, California
• USA01-0 — Wheat Ridge, Colorado
• USA08-0 — Florida City, Florida
• USA10-0 — Atlanta, Georgia
• USA11-0 — Bethesda, Maryland
• USA14-0 — Lincoln, Nebraska
• USA04-0 — New York, New York
• USA15-0 — Portland, Oregon
• USA03-0 — Charleston, South Carolina
• USA13-0 — Anderson, Texas
• USA12-0 — Houston, Texas
• USA05-0 — Virginia Beach, Virginia
• USA09-0 — Puyallup, Washington
• USA07-0 — Spokane, Washington
• AUS07-0 — North Sydney, New South Wales
• AUS06-0 — Benowa, Queensland
• AUS04-0 — Birtinya, Queensland
• AUS05-0 — Adelaide, South Australia
• CHN02-0 — Beijing, Beijing Municipality
• CHN13-0 — Beijing, Beijing Municipality
• CHN23-0 — Beijing, Beijing Municipality
• CHN17-0 — Dongguan, Guangdong
• CHN06-0 — Henan, Henan
• CHN12-0 — Xinxiang, Henan

📞 Contact the Study Coordinator

Phone: (540) 808-3925

Email: jay.ma@dualitybiologics.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Solid Tumors

• Phase II Biomarker Study of BND-22 in Combination With Cemiplimab in Solid Tumors — Houston, Texas
• Study of AUBE00 in Patients With Solid Tumors — Grand Rapids, Michigan
• JAB-2485 Activity in Adult Patients With Advanced Solid Tumors — Detroit, Michigan
• Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors — Basking Ridge, New Jersey
• Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours — Edmonton, Alberta

Explore by condition: All Solid Tumors clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.