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PT0253 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1a, Dose Escalation | EXPERIMENTAL | Participants with any type of solid tumor will receive PT0253 injection, intravenously (IV) until disease progression or intolerance. |
| Part 1b, Dose Expansion: Tumor type 1 | EXPERIMENTAL | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 1 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data for PT0253 established in Part 1a. |
| Part 1b, Dose Expansion: Tumor type 2 | EXPERIMENTAL | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 2 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. |
| Part 1b, Dose Expansion: Tumor type 3 | EXPERIMENTAL | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Cetuximab until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. |
| Part 1b, Dose Expansion: Tumor type 4 | EXPERIMENTAL | Participants with a previously treated tumor type will receive PT0253 injection in combination with intravenous infusion of Chemotherapy Combination 3 until disease progression or intolerance. Recommended dose or doses for expansion for Part 1b will be determined based on the safety, tolerability, PK and PD data for PT0253 established in Part 1a. |
| Name | Type | Description |
|---|---|---|
| PT0253 | DRUG | PT0253 injection. |
| Chemotherapy Combination 1 | DRUG | Intravenous infusion. |
| Chemotherapy Combination 2 | DRUG | Intravenous infusion. |
| Chemotherapy Combination 3 | DRUG | Intravenous infusion. |
| Cetuximab | DRUG | Intravenous infusion. |
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced or metastatic solid malignancy 2. Participant has a pathologically documented, locally advanced or metastatic malignancy with KRAS p.G12D mutation identified through molecular testing using a Clinical Laboratory Improvement A...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PT0253 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development for patients with KRAS G12D mutated advanced solid tumors. The drug is being studied in a controlled clinical trial that requires participants to have this specific genetic biomarker.
PT0253 targets tumors that carry the KRAS G12D mutation, a specific genetic alteration in the KRAS gene. The ongoing Phase 1 trial is specifically designed for participants with KRAS G12D mutated advanced solid tumors, and the study uses biomarker selection to identify eligible patients with this mutation.
PT0253 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is currently conducting a Phase 1 clinical trial of PT0253 in patients with advanced solid tumors.
PT0253 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants in the United States and South Korea.
PT0253 is being studied in a single Phase 1 clinical trial registered as NCT06797336. This trial is titled "A Study of PT0253 in Participants With KRAS G12D Mutated Advanced Solid Tumors" and is currently recruiting participants. The study is enrolling 240 patients aged 18 years and older in the United States and South Korea.
PT0253 is a distinct investigational small molecule being developed for KRAS G12D mutated solid tumors. It is currently in Phase 1 clinical testing, and no alternative names for this drug have been disclosed. Its development is being conducted by cbdMD, Inc. under the trial identifier NCT06797336.