Study on DB-1311 Combined with BNT327 or DB-1305 for Advanced or Metastatic Solid Tumors
Sponsor: DualityBio Inc.
ClinicalTrials ID:NCT06953089
This clinical trial is testing the safety and effectiveness of a new treatment using DB-1311 combined with either BNT327 or DB-1305 in adults with advanced or metastatic solid tumors, including liver, cervical, skin, head and neck, and lung cancers.
Patient Parameters
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Program Overview
This study is a Phase II trial conducted at multiple centers to evaluate the safety and initial effectiveness of the drug DB-1311 when used in combination with either BNT327 or DB-1305. The trial is open to adults with advanced or metastatic cancers, such as liver cancer, cervical cancer, melanoma, head and neck cancer, or non-small cell lung cancer. The goal is to determine how well these drug combinations work in treating these types of cancer.
Description
This clinical trial is designed to test a new treatment approach for people with advanced or metastatic solid tumors. The study involves two parts and is conducted at several locations. It aims to assess the safety and preliminary effectiveness of the drug DB-1311 when combined with either BNT327 or DB-1305. Participants in the trial include those with recurring or progressing cancers such as hepatocellular carcinoma (a type of liver cancer), cervical cancer, melanoma, head and neck squamous cell carcinoma, or non-small cell lung cancer. The trial seeks to find out if these drug combinations can help control these cancers more effectively.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 years or older, or as per local regulations, who agree to participate.
- Have at least one tumor that can be measured by the study doctors.
- Have a life expectancy of at least 3 months.
- Be in good general health, with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have good organ function as shown by tests done within 7 days before joining the study.
- Have stopped previous cancer treatments for a sufficient time before starting the trial treatment.
Exclusion Criteria
- Have previously received treatment targeting B7H3.
- Have previously received an antibody-drug conjugate with a topoisomerase inhibitor.
- Are eligible for local treatments that could potentially lead to a complete or near-complete response and long-term tumor control, as assessed by the study doctor.
- Have any uncontrolled or significant health issues that could interfere with the trial or increase the risk of side effects, according to the study doctor.
- Have uncontrolled or serious heart disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site USA04-0 | 10032 | New York | New York |
| Research Site USA03-0 | 29425 | Charleston | South Carolina |
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