RecruitingPhase 2interventionalRules rewrite

Phase 2: testing DB-1311/BNT324 for 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

Official registry: https://clinicaltrials.gov/study/NCT06953089 · DualityBio Inc. · enrollment listed as 750

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are DB-1311/BNT324, BNT327, or DB-1305/BNT325. The registry lists allocation as randomized. A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

They plan to enroll about 750 people at 37 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: DB-1311/BNT324, BNT327, DB-1305/BNT325

Primary outcome (registry wording): Part 1: Number of participants with Dose Limiting Toxicities (DLTs).

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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

Public study contact (from the registry)

Jay Ma

540-808-3925

jay.ma@dualitybiologics.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

37 listed

USA06-0 — Los Angeles, California (recruiting)
USA16-0 — Los Angeles, California (recruiting)
USA01-0 — Wheat Ridge, Colorado (recruiting)
USA08-0 — Florida City, Florida (recruiting)
USA10-0 — Atlanta, Georgia (recruiting)
USA11-0 — Bethesda, Maryland (recruiting)
USA14-0 — Lincoln, Nebraska (recruiting)
USA04-0 — New York, New York (recruiting)
USA15-0 — Portland, Oregon (recruiting)
USA03-0 — Charleston, South Carolina (recruiting)
USA13-0 — Anderson, Texas (recruiting)
USA12-0 — Houston, Texas (recruiting)

+ 22 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06953089 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06953089?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06953089?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary