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A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors

ConditionAdvanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.

About this trial

This is a multicenter, open-label, multiple-dose, FIH Phase 1a/1b study. Phase 1a adopts an accelerated titration design and a BOIN design to identify the MTD or MAD of DB-1317; Phase 1b includes one randomized dose expansion cohort and two single-arm dose expansion cohorts to further evaluate the safety, tolerability and preliminary efficacy of DB-1317 in selected solid tumors and to identify optimal RP2D.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female adults

Unresectable advanced or metastatic selected solid tumors that have relapsed or progressed on or after standard systemic treatments.

Only applicable to backfilling participants in Phase 1a and participants in Phase 1b: At least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria. Participants with non-measurable disease are allowed for CRPC participants.

Has a life expectancy of ≥ 3 months.

Disqualifiers

Prior treatment with ADAM9 targeted therapy.

Prior treatment with antibody-drug conjugate with topoisomerase I inhibitor.

Has a medical history of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment.

Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • DB-1317

    Drug

    Administered I.V.

Treatment groups

253 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: DB-1317 Dose Level 1Experimental treatment 1 intervention
Group B: DB-1317 Dose Level 2Experimental treatment 1 intervention
Group C: DB-1317 Dose Level 3Experimental treatment 1 intervention
Group D: DB-1317 Dose Level 4Experimental treatment 1 intervention
Group E: DB-1317 Dose Level 5Experimental treatment 1 intervention
Group F: DB-1317 Dose Expansion 1Experimental treatment 1 intervention
Group G: DB-1317 Dose Expansion 2Experimental treatment 1 intervention
Group H: DB-1317 Dose Expansion 3Experimental treatment 1 intervention
Group I: DB-1317 Dose Level 6Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1a: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0. Percentage of participants in Part 1 with DLTs

Percentage of participants in Phase 1a with DLTs

Time frame
up to 21 days after Cycle 1 Day 1
2

Phase 1a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.

Percentage of participants with TEAEs in Phase 1a graded according to NCI CTCAE v5.0

Time frame
Up to follow-up period, approximately 1 year post-treatment
3

Phase 1a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.

Percentage of Participants with SAEs in Phase 1a graded according to NCI CTCAE v5.0

Time frame
Up to follow-up period, approximately 1 year post-treatment
4

Maximum Tolerated Dose (MTD) of DB-1317

MTD on the data collected during Phase 1a

Time frame
Up to the completion of Phase 1a (assessed up to 12 months)

Secondary outcomes

1

Phase 1a: Objective response rate (ORR)

ORR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

Time frame
Up to follow-up period, approximately 1 year post-treatment
2

Phase 1a: duration of response (DoR)

DoR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

Time frame
Up to follow-up period, approximately 1 year post-treatment
3

Phase 1a: disease-control rate (DCR)

DCR will be determined from tumor assessments by investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)

Time frame
Up to follow-up period, approximately 1 year post-treatment
4

Phase 1a: Time to Response (TTR)

TTR will be determined from tumor assessments by investigator per response evaluation TTR criteria in solid tumors version 1.1 (RECIST v1.1)

Time frame
Up to follow-up period, approximately 1 year post-treatment

Other outcomes

Sponsors and contacts

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

DualityBio Inc.

Lead sponsor

Source ClinicalTrials.gov
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