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.
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the RCD\_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and the RCD\_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved trastuzumab biosimilar or in combination with Osimertinib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
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
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
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-1310
MTD on the data collected during Part 1
Time frame: 12 months
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1310
RP2D of DB-1310 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 TEAE 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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UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
RECRUITINGD&H Cancer Research Center LLC
Margate, Florida, United States
RECRUITINGSarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States
RECRUITINGBRCR global
Plantation, Florida, United States
RECRUITINGFlorida Cancer Specialists
Sarasota, Florida, United States
RECRUITINGBRCR Medical Center Inc.
Tamarac, Florida, United States
RECRUITINGResearch Site 111
Atlanta, Georgia, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITING...and 11 more locations
Phase 2a: 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-1310, total antibody and payload
Time frame: within 8 cycles (each cycle is 21 days)
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)
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)
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)
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1: ORR will be determined from tumor assessments by investigator per RECIST 1.1
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1 \& Phase 2a: duration of response (DoR) will be determined from tumor assessments by investigator (by BICR in cohort 3 in Phase 2a) per RECIST 1.1
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: disease-control rate (DCR)
Phase 1 \& Phase 2a: disease-control rate (DCR)
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
Phase 1 \& Phase 2a: progression free survival (PFS) will be determined from tumor assessments by investigator per RECIST 1.1
Time frame: with 8 cycles (each cycle is 21 days)
Phase 1 & Phase 2a: overall survival (OS)
Phase 1 \& Phase 2a: overall survival (OS)
Time frame: with 8 cycles (each cycle is 21 days)