First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
NCT Number: NCT06554795
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor, Adult
Interventions: DRUG: DB-1419
Sponsor: DualityBio Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-02
Locations: Site USA01, Tucson, Arizona, 85711, United States|Site USA02, Florida City, Florida, 32827, United States|Site USA03, Carolina, North Carolina, 28078, United States|AUS02-0, Nedlands, Australia|AUS03-0, North Ryde, Australia|AUS01-0, Randwick, Australia|Site CHN08-0, Ha'erbin, China|Site CHN04-0, Jinan, China|Site CHN03-0, Luoyang, China|Site CHN06-0, Shanghai, China

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

Primary Outcome Measures: 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, Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first|Phase 1/2a: Percentage of Participants with serious AE (SAE), Percentage of participants with SAEs graded according to NCI CTCAE v5.0, Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first|Phase 1a: Maximum Tolerated Dose (MTD), MTD on the data collected during Part 1, From first study treatment administration until the initiation of Phase1b/2a, approximately up to 12 months.|Phase 1a: Recommended Phase 2 Dose (RP2D), RP2D of DB-1419 based on the data collected during Part 1, From first study treatment administration until the initiation of Phase 1b/2a, approximately up to 12 months.|Phase 1b/2a: Objective Response Rate (ORR) determined by Investigator per RECIST v1.1, The percentage of subjects who had a best response rating of CR and PR, 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.
Secondary Outcome Measures: Phase 1a: ORR determined from tumor assessments by Investigator per RECIST v1.1, The percentage of subjects who had a best response rating of CR and PR, 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.|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, 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|Phase 1/2a: OS, overall survival (OS), 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.|Phase 1/2a: AUC0-last, the area under the concentration-time curve from time zero to the last quantifiable concentration, within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: AUC0-tau, the area under the concentration-time curve from time zero to time tau, within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: AUCinf, the area under the concentration-time curve from time zero to infinite, within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: Cmax, peak observed concentration, within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: Tmax, Time to Cmax, within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: Ctrough, trough concentration, within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: ADA prevalence, the proportion of participants who are ADA positive at any point in time (at baseline and post-baseline), within 8 cycles (each cycle is 21 days or 14 days)|Phase 1/2a: ADA incidence, the proportion of participants having treatment-emergent ADA., within 8 cycles (each cycle is 21 days or 14 days)