Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LP-184 · 2 trials · 8 indications
Incidence and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
| Arm | Type | Description |
|---|---|---|
| 10 subjects in the IDHwt arm | EXPERIMENTAL | If, among the first 10 enrolled participants in the IDHwt arm, at least 1 subject achieves an objective response, an additional 19 subjects will be enrolled in that arm. Spironolactone is administered with each STAR-001 infusion. |
| 10 subjects in the IDHm Grade 4 astrocytoma arm | EXPERIMENTAL | If, among the first 10 enrolled participants in the IDHm Grade 4 astrocytoma arm, at least 1 subject achieves an objective response, an additional 19 subjects will be enrolled in that arm. |
| Master Protocol | EXPERIMENTAL | A phase 1/2 dose escalation and cohort expansion study of LP-184 in patients with advanced or metastatic solid tumors. A BOIN design will be used to evaluate the safety of LP-184, determine the MTD, and identify the RP2D. Patients who meet all eligibility criteria will be enrolled to receive treatment with LP-184 at a dose determined based on the available cohort at the time of each patient's enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. |
| Supplement A | EXPERIMENTAL | Phase 1b/2 Expansion cohort of participants with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), pancreatic adenocarcinoma (PDAC) or other solid tumours with known DDR genomic alterations to determine the optimal dose/RP2D and to obtain preliminary estimates of clinical activity. |
| Supplement C | EXPERIMENTAL | Phase 1b/2 Expansion cohort of participants with Hormone Receptor (HR)-Negative and HER2-Negative Breast Cancer (TNBC) to evaluate the safety, tolerability and clinical activity of LP-184 in combination with olaparib |
| Supplement D | EXPERIMENTAL | Phase 1b/2 Expansion cohort of participants with KEAP1 and/or STK11-mutated and programmed cell death ligand-1 (PD-L1)-low NSCLC to evaluate the safety, tolerability and clinical activity of LP-184 in combination with nivolumab and ipilimumab in . |
| Name | Type | Description |
|---|---|---|
| STAR-001 (LP-184) will be administered via IV infusion over 30 (± 5) minutes on Day 1 and Day 8 of each 21-day cycle. | DRUG | The current study treatment will use STAR-001 in combination with the oral diuretic spironolactone. In preclinical tumor models, co-treatment with spironolactone (SP), a transcription-coupled nucleotide excision repair (TC-NER) inhibitor, sensitized GBM cells and xenografts to STAR-001(LP-184). |
| Spironolactone (drug) | DRUG | Spironolactone will be administered orally upon awakening taken without food on Day -2, Day -1 and Day 1 (4-8 hours prior to the STAR-001 infusion) and on Day 6, Day 7, and on Day 8. |
| LP-184 | DRUG | LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage. |
| Olaparib | DRUG | A poly (ADP-ribose) polymerase (PARP) inhibitor that impairs homologous recombination (HR) dependent DNA damage repair by trapping PARP1/2 on DNA, leading to synthetic lethality in BRCA1/2-deficient cells. |
| Nivolumab & Ipilimumab | DRUG | Nivolumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the PD-1 receptor on the surface of T cells, Nivolumab restores immune cells' ability to recognize and attack cancer cells. Ipilimumab is monoclonal antibody and classified as an immune checkpoint inhibitor. By blocking the CTLA4 protein on the surface of T cells, Ipilimumab activates T-cells and allows T-cells to attack cancer cells. |
Inclusion Criteria: 1. Histopathology confirmed supratentorial GBM at first recurrence including both IDHwt GBM and IDHm Grade 4 astrocytoma. 2. Provision of archival tissue and in re-resected subjects, contemporaneous tissue. 3. No more than one prior systemic treatment (temozolomide + involved fi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
LP-184 is an investigational small molecule being studied for the treatment of advanced solid tumors and glioblastoma (GBM). It is being developed by Lantern Pharma Inc. and is currently in Phase 1 clinical development. LP-184 has not been approved by the FDA for any indication.
LP-184 is being developed by Lantern Pharma Inc., which trades on the Nasdaq under the ticker symbol LTRN. The company is sponsoring clinical trials of LP-184 in advanced solid tumors and glioblastoma.
LP-184 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes a study in advanced solid tumors and a Phase 1b/2a study in glioblastoma.
LP-184 is being evaluated in two clinical trials. NCT05933265 is a Phase 1 study in patients with advanced solid tumors, including GBM, triple-negative breast cancer, NSCLC, and pancreatic adenocarcinoma. NCT07431216 is a Phase 1b/2a study of STAR-001 (LP-184) in combination with spironolactone in supratentorial glioblastoma at first progression.
Yes, STAR-001 is another name for LP-184. STAR-001 (LP-184) is administered via IV infusion over 30 minutes on Day 1 and Day 8 of each 21-day cycle in the glioblastoma trial.