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

Sponsor: DualityBio Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05150691

Patient View

This Phase 1/2a trial assesses DB-1303/BNT323's safety in HER2-expressing tumors. It includes dose-escalation and expansion phases. Eligible participants have advanced HER2-positive tumors, measurable lesions, and adequate organ function. Exclusions include cardiac issues and active infections. Interventions involve DB-1303/BNT323, pertuzumab, ritonavir, and itraconazole.

Patient Parameters

Program Overview

This 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.

Description

This is a multicenter, non-randomized (Except for Dose Expansion 1 and Dose Expansion 9 cohorts), open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors at the MTD/the RP2D. This study will enroll subjects with advanced/unresectable, recurrent, or metastatic HER2-expressing malignant solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
  • At least 1 measurable lesion (per RECIST 1.1)
  • Provide signed informed consent
  • ECOG performance status (PS) of 0-1.
  • LVEF ≥ 50% by ECHO or MUGA
  • Adequate organ functions
  • Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing.
  • Life expectancy of ≥ 3 months.

Additional Inclusion Criteria for Part 2 Expansion Group 9:

  1. Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.

Exclusion Criteria

  • History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
  • History of myocardial infarction or unstable angina within 6 months before Day 1.
  • Average QTcF > 450 ms in males and > 470 ms in females
  • History of clinically significant lung diseases
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
  • HIV infection with AIDS defining illness or active viral hepatitis.
  • Clinically active brain metastases
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline.
  • A known hypersensitivity to either the drug substances or inactive ingredients in the drug product.
  • Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.

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