RecruitingSolid Tumors

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Sponsor: DualityBio Inc.

✓ 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.
✓ For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.
✓ For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology

✕ 1\. 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. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy.
✕ Has a history of (non-infectious) ILD/pneumonitis.
✕ Any autoimmune, connective tissue or inflammatory disorders.
✕ Has spinal cord compression or clinically active central nervous system (CNS) metastases.