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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
DB-1303/BNT323 Dose Level 1 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Level 2 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Level 3 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Level 4 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Level 5 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 1 		Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
  • Drug: Pertuzumab Injection
    Administered IV
  • Drug: Ritonavir
    Administered oral
  • Drug: Itraconazole
    Administered oral
Experimental
DB-1303/BNT323 Dose Expansion 2 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 3 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 4 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 5 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Level 6 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Level 7 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 6 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 7 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 8 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 9 		Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 10 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential
  • Biological: DB-1303/BNT323
    Administered IV
  • Drug: Ritonavir
    Administered oral
  • Drug: Itraconazole
    Administered oral
Experimental
DB-1303/BNT323 Dose Expansion 11 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 12 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
  • Drug: Pertuzumab Injection
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 13 		Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV
Experimental
DB-1303/BNT323 Dose Expansion 14 		China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
  • Biological: DB-1303/BNT323
    Administered IV

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02214

More Details

Status
Recruiting
Sponsor
DualityBio Inc.

Study Contact

Britney Winterberger
+1-513-403-8568
britney.winterberger@tigermedgrp.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.