DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.
About this trial
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DB-1311/BNT324
- BNT327
- DB-1305/BNT325
Treatment groups
450 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Sponsors and collaborators
DualityBio Inc.
Lead sponsor
BioNTech SE
Collaborator
Source ClinicalTrials.gov