Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LP-284 · 1 trial · 2 indications
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...
LP-284 is an investigational small molecule being developed for the treatment of relapsed or refractory lymphomas. It is also being studied in patients with advanced solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
LP-284 is being developed by Lantern Pharma Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol LTRN. The company is conducting clinical trials to evaluate the safety and efficacy of LP-284 in patients with certain types of cancer.
LP-284 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA. The ongoing Phase 1 trial is recruiting patients to evaluate the safety, pharmacokinetics, and clinical activity of LP-284.
LP-284 is being studied in a Phase 1 clinical trial with the identifier NCT06132503. This trial is titled 'Safety, Pharmacokinetics, and Clinical Activity of LP-284 in Adult Patients With Relapsed or Refractory Lymphomas and Solid Tumors' and is currently recruiting participants in the United States.
Yes, LP-284 has received orphan drug designation from the FDA. This designation is granted to drugs intended for the treatment of rare diseases or conditions, and it may provide certain development and commercialization incentives to the sponsor.