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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • DB-1311/BNT324

    Drug

    Administered I.V.

  • BNT327

    Drug

    Administered I.V.

  • DB-1305/BNT325

    Drug

    Administered I.V.

Treatment groups

450 Participants
are divided into 13 treatment groups

13

Treatment groups

See each treatment group below.

Group A: Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapyExperimental treatment 2 interventions
Group B: Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapyExperimental treatment 2 interventions
Group C: Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group D: Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group E: Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group F: Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group G: Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325Experimental treatment 2 interventions
Group H: Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapyExperimental treatment 2 interventions
Group I: Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group J: Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group K: Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group L: Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions
Group M: Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1: Number of participants with Dose Limiting Toxicities (DLTs).

Time frame
During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
2

Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)

Time frame
up to follow up period, e.g. up to 72 months.
3

Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level]

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
4

Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment)by arm and dose level.

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

Secondary outcomes

1

Part 1: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment).

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
2

Part 1 and 2: Duration of response (DoR) per RECIST 1.1 based on the investigator's assessment.

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
3

Part 1 and 2: Overall survival (OS)

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
4

Part 1 and 2: Disease-control rate (DCR) per RECIST 1.1 based on the investigator's assessment.

Time frame
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

DualityBio Inc.

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov
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