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First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors

ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.

About this trial

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥ 18 years at the time of voluntarily signing informed consent.

Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available.

At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria (Only applicable to backfill participants in phase 1a and participants in phase 1b/2a). CRPC participants with bone-only disease may be eligible on a case-by-case basis after discussion with the Medical Monitor.

Has a life expectancy of ≥ 3 months.

Disqualifiers

Prior treatment with B7-H3 targeted therapy or prior treatment with ADC containing a topoisomerase I inhibitor payload.

Has a medical history of symptomatic congestive heart failure (New York Heart Association [NYHA] classes II-IV or serious cardiac arrhythmia requiring treatment.

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

Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to > 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DB-1419

    Drug

    Administered Injection of Vein (I.V.)

Treatment groups

360 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Group A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Group E: Dose Level 5Experimental treatment 1 intervention
Group F: Dose Level 6Experimental treatment 1 intervention
Group G: Dose Expansion 1Experimental treatment 1 intervention
Group H: Dose Expansion 2Experimental treatment 1 intervention
Group I: Dose Expansion 3Experimental treatment 1 intervention
Group J: Dose Expansion 4Experimental treatment 1 intervention
Group K: Dose Expansion 5Experimental treatment 1 intervention
Group L: Dose Expansion 6Experimental treatment 1 intervention
Group M: Dose Expansion 7Experimental treatment 1 intervention
Group N: Dose Expansion 8Experimental treatment 1 intervention
Group O: Dose Level 7Experimental treatment 1 intervention
Group P: Dose Level 8Experimental treatment 1 intervention
Group Q: Dose Level 9Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1/2a: Percentage of Participants with Adverse events (AE) serious AE (SAE)

Percentage of participants with TEAEs graded according to NCI CTCAE v5.0

Time frame
Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
2

Phase 1/2a: Percentage of Participants with serious AE (SAE)

Percentage of participants with SAEs graded according to NCI CTCAE v5.0

Time frame
Up to 90 days after last study treatment administration or before starting new anticancer treatment, whichever comes first
3

Phase 1a: Maximum Tolerated Dose (MTD)

MTD on the data collected during Part 1

Time frame
From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.
4

Phase 1a: Recommended Phase 2 Dose (RP2D)

RP2D of DB-1419 based on the data collected during Part 1

Time frame
From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.

Secondary outcomes

1

Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1

The percentage of subjects with best overall response of CR and PR

Time frame
Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months.
2

Phase 1/2a: Progression free survival (PFS) determined from tumor assessments by Investigator per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1

PFS will be determined from tumor assessments by investigator per RECIST 1.1

Time frame
Up to disease progression or death or before starting new anticancer treatment or withdrawal from the trial, whichever comes first, approximately up to 12 months
3

Phase 1/2a: OS

overall survival (OS)

Time frame
From the start date of study drug to the date of death due to any cause, whichever occurs first, approximately up to 12 months after last patient first dose.
4

Phase 1/2a: AUC0-last

the area under the concentration-time curve from time zero to the last quantifiable concentration

Time frame
within 8 cycles (each cycle is 21 days or 14 days)

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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