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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 (Sep 2026). This Phase 2 trial studies multiple treatments including DB-1311/BNT324 and BNT327 for solid tumors.

Phase 2RecruitingDualityBio Inc.NCT06953089Data as of Sep 2026Location: United States · Australia · China

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

Treatments studied

Other

DB-1311/BNT324BNT327DB-1305/BNT325

Cancer type

Tumor Agnostic

Hepatocellular Carcinoma

Cervical Cancer

Melanoma

Ovarian Cancer

Head and Neck Squamous Cell Carcinoma

Non-Small Cell Lung Carcinoma

Pancreatic Cancer

Breast Carcinoma

Triple-Negative Breast Cancer

Colorectal Cancer

Prostate Cancer

Biomarker criteria

Required: EGFR sensitizing mutation

Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations

Required: ALK rearrangement

Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations

Disease stage

Metastatic disease required

At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria

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

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 →

Frequently asked questions

Is NCT06953089 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior B7H3 targeted therapy, antibody-drug conjugate with topoisomerase inhibitor disqualifies patients from enrollment.

Does this trial require EGFR?

Yes, EGFR sensitizing mutation is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK rearrangement is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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