Evaluating DB-1303/BNT323 for HER2-positive advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2a trial aims to assess the safety and tolerability of DB-1303/BNT323 in patients with advanced solid tumors that express HER2. The study is divided into two parts: the first part uses a dose-escalation approach to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), while the second part focuses on expanding the cohort to confirm safety and explore efficacy at the identified dose. Participants will be enrolled based on specific criteria, including having measurable lesions and being refractory to standard treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first affiliated hospital of Bengbu medical college
  Bengbu, Anhui, China Recruiting
• Anhui provincial hospital
  Hefei, Anhui, China Recruiting
• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital Chinese Academy of Medical Science
  Beijing, Beijing Municipality, China Recruiting
• The First Hospital of Jilin University
  Hongcun, Changchun, China Recruiting

+52 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Britney Winterberger
• Email: britney.winterberger@tigermedgrp.com
• Phone: +1-513-403-8568

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.