Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PTM-101 · 1 trial · 4 indications
Number of subjects with PTM-101/PTM-101 placement-related adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Dose escalation will follow a modified (3+3) design to establish the preliminary RP2D and characterize the safety and pharmacokinetic profile of PTM-101, which will be taken together with all prior clinical data to establish and characterize the preliminary RP2D. A maximum of 12 subjects with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101 combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months. |
| Dose Expansion | EXPERIMENTAL | The dose of PTM-101 will be the preliminary RP2D determined from all available clinical data. Up to 20 subjects, inclusive of those already assigned to the preliminary RP2D in the dose escalation part, with treatment-naïve, borderline resectable or locally advanced PDAC will be recruited and receive PTM-101, combined with standard of care neoadjuvant chemotherapy, and be followed for a minimum of 24 months. |
| Name | Type | Description |
|---|---|---|
| PTM-101 | DRUG | PTM-101, an absorbable drug product containing paclitaxel |
Inclusion Criteria: * Imaging consistent with primary borderline resectable or locally advanced PDAC. PDAC may be confirmed by histology/cytology either at study-mandated laparoscopy or by prior biopsy/cytology * Indicated for laparoscopy * No prior therapy of any kind for PDAC * Acceptable laborat...
PTM-101 is an investigational small molecule being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC), including borderline resectable and locally advanced pancreatic adenocarcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
PTM-101 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials for this investigational drug candidate.
PTM-101 is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 trial is currently recruiting participants to evaluate the drug in patients with pancreatic ductal adenocarcinoma.
PTM-101 is being studied in a Phase 1 clinical trial with the identifier NCT06673017, titled 'PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)'. The trial is recruiting 26 participants in the United States and Australia, and is open to adults aged 18 years and older.
PTM-101 is a small molecule being developed for pancreatic ductal adenocarcinoma. The trial includes biomarker selection, indicating that patients may be selected based on specific biomarkers. However, the specific molecular target of PTM-101 has not been disclosed in the available information.