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OncoMatch/Clinical Trials/NCT06953089

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

Is NCT06953089 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including DB-1311/BNT324 and BNT327 for solid tumors.

Phase 2RecruitingDualityBio Inc.NCT06953089Data as of May 2026

Treatment: DB-1311/BNT324 · BNT327 · DB-1305/BNT325A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: EGFR sensitizing mutation

Not harboring an EGFR-sensitizing mutation

Required: ALK gene rearrangements

Not harboring...ALK gene rearrangements

Disease stage

Required: Stage III, IIIB, IIIC, IV

Metastatic disease required

At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria. unresectable Stage III or metastatic melanoma. Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: B7H3 targeted therapy

Prior treatment with B7H3 targeted therapy.

Cannot have received: antibody-drug conjugate with topoisomerase inhibitor

Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.

Lab requirements

Liver function

Has a Child-Pugh class A liver score (for HCC patients)

Has a Child-Pugh class A liver score. Has adequate organ function within 7 days prior to enrollment/randomization.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial 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

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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