Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B).
Part A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BA1202 | Experimental | BA1202 is a bispecific antibody targeting CEA and CD3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BA1202 | Drug | BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years. Part A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg. Part B: Based on the data of part A, one or two dose levels will be discussed for further evaluation in part B. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) of BA1202 | Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.) | |
| Area under the curve (AUC) of BA1202 | Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Minimum Concentration (Cmin) of BA1202 | Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.) |
| Time of maximum concentration (Tmax) of BA1202 | Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.) |
| Objective Response Rate (ORR) | up to 2 years |
| Disease Control Rate (DCR) | up to 2 years |
| Duration of Response (DOR) | up to 2 years |
| Overall Survival (OS) | up to 2 years |
| Progression-Free Survival (PFS) | up to 2 years |
| Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab) | Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.) |