DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Sponsor: DualityBio Inc.
ClinicalTrials ID:NCT06953089
This Phase II, multicenter, open-label trial assesses the safety and preliminary efficacy of DB-1311 combined with BNT327 or DB-1305 in adults with advanced/metastatic HCC, CC, melanoma, HNSCC, or NSCLC. Eligible participants must have measurable lesions, a life expectancy of ≥3 months, ECOG PS 0-1, and adequate organ function. Interventions are administered intravenously.
Patient Parameters
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Program Overview
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
Description
This is a phase II, multicenter, open-label, two-part trial designed to evaluate the safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 in targeted participants.
Participants with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC) are eligible to participate in the trial.
Eligibility Criteria
Inclusion Criteria
- Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
- At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
- Has a life expectancy of ≥ 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- Has adequate organ function within 7 days prior to enrollment/randomization,
- Has adequate treatment washout period prior to the first dose of trial treatment.
Exclusion Criteria
- Prior treatment with B7H3 targeted therapy.
- Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
- Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
- Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
Exclusion Criteria:
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- Prior treatment with B7H3 targeted therapy.
- Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.
- Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.
- Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.
- Has uncontrolled or significant cardiovascular 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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