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OncoMatch/Clinical Trials/NCT05150691

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Is NCT05150691 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including DB-1303/BNT323 and Pertuzumab for her2-positive advanced solid tumor.

Phase 1/2RecruitingDualityBio Inc.NCT05150691Data as of May 2026

Treatment: DB-1303/BNT323 · Pertuzumab · Ritonavir · ItraconazoleThis is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: HER2 (ERBB2) overexpression

HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null)

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

adequate organ functions

Kidney function

adequate organ functions

Liver function

adequate organ functions

Cardiac function

LVEF ≥ 50% by ECHO or MUGA; no history of symptomatic CHF (NYHA II-IV) or serious cardiac arrhythmia requiring treatment; no history of myocardial infarction or unstable angina within 6 months before Day 1; average QTcF > 450 ms in males and > 470 ms in females excluded

LVEF ≥ 50% by ECHO or MUGA; adequate organ functions; history of symptomatic CHF (NYHA II-IV) or serious cardiac arrhythmia requiring treatment [excluded]; history of myocardial infarction or unstable angina within 6 months before Day 1 [excluded]; average QTcF > 450 ms in males and > 470 ms in females [excluded]

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

US trial sites

  • Helios Clinical Research · Cerritos, California
  • California Research Institute · Los Angeles, California
  • Sharp Memorial Hospital · San Diego, California
  • Washington Cancer Institute at MedStar Washington Hospital Center · Washington D.C., District of Columbia
  • Advanced Research LLC · Coral Springs, Florida

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

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