Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06132503 | Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors | PHASE1 | RECRUITING | 110 | — | — | Jan 3, 2023 | Nov 30, 2028 | May 4, 2026 | 1 | United States |
Evaluate the safety and tolerability of escalating doses of LP-284 by measuring the incidence and severity of adverse events (AEs) of escalating doses of LP-284 to determine the maximum tolerated dose (MTD) in patients with relapsed or refractory (R/R) lymphomas and solid tumors
Determine the maximum tolerated dose (MTD) of LP-284 by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, clinical laboratory, and electrocardiogram (ECG) abnormalities defined as dose-limiting toxicities (DLTs) in patients with relapsed or refractory (R/R) lymphomas and solid tumors
Determine the recommended Phase 2 dose (RP2D) of LP-284 by measuring the incidence and severity of adverse events (AEs) graded according to NCI CTCAE 5.0, clinical laboratory, and electrocardiogram (ECG) abnormalities defined as dose-limiting toxicities (DLTs) in patients with relapsed or refractory (R/R) lymphomas and solid tumors
To obtain preliminary estimates of clinical activity by examining the overall response rate, based on Investigator's assessment as per Lugano criteria, of LP-284 in adult patients with relapsed/refractory MCL and DLBCL
| Arm | Type | Description |
|---|---|---|
| Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-284 | EXPERIMENTAL | The Phase 1a dose escalation portion of the study will identify the maximum tolerated dose (MTD) and/or optimal dose(s) of LP-284 as the RP2D, based on all available safety, PK, PD, and/or preliminary efficacy data. Phase 1b will consist of the dose expansion portion in a separate cohort(s) of patients to further evaluate the safety of LP-284 at the RP2D and obtain preliminary estimates of clinical activity of LP-284 in patients with DLBCL and MCL. |
| Name | Type | Description |
|---|---|---|
| LP-284 | DRUG | LP-284 is a small molecule alkylating agent causing tumor cell death through DNA damage. |
Inclusion Criteria All Patients: Phase 1a and Phase 1b 1. Male or female aged ≥ 18 years on the day of signing informed consent. 2. Patient is capable of giving signed informed consent as described in Section 11.3 which includes compliance with the requirements and restrictions listed in the inform...