A Study of DB-1303 in Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303 in subjects with advanced solid tumors that express HER2.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DualityBio Inc.
• Treatments: Itraconazole; Pertuzumab; Ritonavir

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.

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.

• 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.