Health TrialsbyHealthPanel

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

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

About this trial

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).

Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease.

At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.

Has a life expectancy of ≥ 3 months.

Disqualifiers

Prior treatment with HER3 targeted therapy.

Prior treatment with antibody drug conjugate with topoisomerase I inhibitor (except topoisomerase I inhibitor HER2 ADC for backfilled subjects in Combo A of Phase 1 and subjects in Cohort 2e of Phase 2a, and not applicable for subjects enrolled for DLT observation in Phase 1).

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

Has a medical history of myocardial infarction or unstable angina or cerebrovascular accident including transient ischemic attack (TIA) within 6 months before first dose. Or has uncontrolled hypertension (defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).

Trial design

Design model

Sequential

Treatments tested in this trial

  • DB-1310

    Drug

    Administered I.V.

  • Trastuzumab

    Drug

    Administered I.V.

  • Osimertinib

    Drug

    Oral

  • capecitabine

    Drug

    Oral

Treatment groups

1,000 Participants
are divided into 25 treatment groups

25

Treatment groups

See each treatment group below.

Group A: DB-1310 Dose Level 1Experimental treatment 1 intervention
Group B: DB-1310 Dose Level 2Experimental treatment 1 intervention
Group C: DB-1310 Dose Level 3Experimental treatment 1 intervention
Group D: DB-1310 Dose Level 4Experimental treatment 1 intervention
Group E: DB-1310 Dose Level 5Experimental treatment 1 intervention
Group F: DB-1310 Dose Level 6Experimental treatment 1 intervention
Group G: DB-1310 Dose Level 7Experimental treatment 1 intervention
Group H: DB-1310 Dose Level 8Experimental treatment 2 interventions
Group I: DB-1310 Dose Level 9Experimental treatment 2 interventions
Group J: DB-1310 Dose Level 10Experimental treatment 2 interventions
Group K: DB-1310 Dose Level 11Experimental treatment 2 interventions
Group L: DB-1310 Dose Level 12Experimental treatment 2 interventions
Group M: DB-1310 Dose Level 13Experimental treatment 2 interventions
Group N: DB-1310 Dose Expansion 1Experimental treatment 1 intervention
Group O: DB-1310 Dose Expansion 2Experimental treatment 1 intervention
Group P: DB-1310 Dose Expansion 3Experimental treatment 1 intervention
Group Q: DB-1310 Dose Expansion 4Experimental treatment 1 intervention
Group R: DB-1310 Dose Expansion 5Experimental treatment 2 interventions
Group S: DB-1310 Dose Expansion 6Experimental treatment 1 intervention
Group T: DB-1310 Dose Expansion 7Experimental treatment 2 interventions
Group U: DB-1310 Dose Expansion 8Experimental treatment 2 interventions
Group V: DB-1310 Dose Expansion 9Experimental treatment 1 intervention
Group W: DB-1310 Dose Expansion 10Experimental treatment 1 intervention
Group X: DB-1310 Dose Expansion 11Experimental treatment 1 intervention
Group Y: DB-1310 Dose Expansion 12Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: 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 Part 1 with DLTs

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

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

Percentage of participants with TEAE in Part 1 graded according to NCI CTCAE v5.0

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

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

Percentage of Participants with SAEs in Part 1 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-1310

MTD on the data collected during Part 1

Time frame
12 months

Secondary outcomes

1

Phase 1 & Phase 2a: Pharmacokinetic-AUC

Area under the concentration-time curve from time 0 to infinity of DB-1310, total antibody and payload

Time frame
within 8 cycles (each cycle is 21 days)
2

Phase 1 & Phase 2a: Pharmacokinetic-Cmax

Maximum observed plasma concentration (Cmax) of DB-1310, total antibody and payload

Time frame
within 8 cycles (each cycle is 21 days)
3

Phase 1 & Phase 2a: Pharmacokinetic-Tmax

Time to Cmax of DB-1310, total antibody and payload

Time frame
within 8 cycles (each cycle is 21 days)
4

Phase 1 & Phase 2a: Pharmacokinetic-T1/2

Phase 1 \& Phase 2a: Pharmacokinetic-T1/2 of DB-1310, total antibody and payload

Time frame
within 8 cycles (each cycle is 21 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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