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
| Name | Class |
|---|---|
| AntibodyChem Biosciences, Inc. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory to standard of care therapy or for whom no standard of care options are available. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of single agent LCB02A is determined, the study will proceed to Phase 2 expansion cohorts in selected tumor types.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCB02A monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB02A | Drug | CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of LCB02A (Phase 1 and 2) | Incidence and severity of AEs | Up to 48 months |
| Recommended Phase 2 dose of LCB02A (Phase 1) | Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics | Up to 24 months |
| Objective response rate (Phase 2) | Assessed by RECIST 1.1 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of LCB02A (Phase 1 and 2) | Pharmacokinetic parameters will be determined from observed concentrations of LCB02A | Up to 48 months |
| Duration of Response (Phase 1 and 2) | Assessed by RECIST v1.1 |
Not provided
Key Inclusion Criteria:
Phase 1 Dose Escalation: histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment.
Phase 2 Dose Expansion: selected histologically or cytologically confirmed advanced solid tumors that are Claudin 18.2 positive and refractory to standard of care treatment. Expansion cohort indications will be prioritized based on data from the Phase 1 dose escalation portion.
Prior treatment with Claudin 18.2 directed therapy is permitted.
Measurable disease as defined by RECIST v1.1
Willingness to provide archival tumor tissue when available, or to undergo a pre-treatment biopsy if archival tissue is not available.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function as defined by:
Key Exclusion Criteria:
Note: Patients may be considered for enrollment if they have previously treated brain metastases that are clinically stable or radiologically stable for at least 14 days prior to the first dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Browning | Contact | +1-615-975-7776 | clinicaltrials@ligachembio.com |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo Ruiz Soto, M.D. | LigaChem Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 48 months |
| Disease control rate (Phase 1 and Phase 2) | Assessed by RECIST v1.1 | Up to 48 months |
| Progression Free Survival (Phase 1 and Phase 2) | Assessed by RECIST v1.1 | Up to 48 months |
| Overall Survival (Phase 1 and Phase 2) | Up to 48 months |
| Medical University of South Carolina | Charleston | South Carolina | 29406 | United States |
|
| Princess Margaret Hospital | Toronto | Ontario | M5S 3H2 | Canada |
|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
|
| ASAN Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |