This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1201 in subjects with advanced solid tumors.
This is a multicenter, non-randomized, open-label, multiple-dose, FIH study. The study consists of two parts: Part 1 adopts a rule based "3 + 3" design to identify MTD/RP2D; Part 2 is a dose expansion phase to confirm the safety, tolerability and efficacy in selected solid malignant tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Administered I.V.
Fudan University Shanghai Cancer Center
Shanghai, China
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by CTCAE v5.0
Percentage of participants in Part 1 with DLTs
Time frame: up to 21 days after Cycle 1 Day 1
Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0
Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 1 year post-treatment
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
Maximum Tolerated Dose (MTD) of DB-1202
MTD on the data collected during Part 1
Time frame: 12 months
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1202
RP2D of DB-1202 based on the data collected during Part 1
Time frame: 12 months
Phase 2a: Percentage of Participants with Treatment Emergent adverse events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 2a: Percentage participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0
Time frame: Up to follow-up period, approximately 1 year post-treatment
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Percentage of Objective Response Rate (ORR) as assessed by RECIST 1.1.
The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1 & Phase 2a: Pharmacokinetic-AUC
Area under the concentration-time curve from time 0 to infinity of DB-1202
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Cmax
Maximum observed plasma concentration (Cmax) of DB-1202
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-Tmax
Time to Cmax of DB-1202
Time frame: within 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: Pharmacokinetic-T1/2
Terminal elimination half-life
Time frame: within 8 cycles (each cycle is 21 days)