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CM-24 and Nivolumab · 1 trial · 7 indications
Incidence of treatment emergent adverse events with CM-24 and nivolumab in adults with selected recurrent or metastatic solid tumors
Incidence of treatment emergent adverse events with CM-24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV in adults with advanced metastatic pancreatic cancer
This is an exploratory randomized sub-study with the objective of estimating the efficacy of CM24 and nivolumab with chemotherapy (Nal-IRI/5-FU/LV or gemcitabine/ nab-paclitaxel) and chemotherapy only (Nal- IRI/5-FU/LV or gemcitabine/nab-paclitaxel) as measured by overall survival.
| Arm | Type | Description |
|---|---|---|
| Part A- Dose escalation of CM24 in combination with nivolumab | EXPERIMENTAL | - |
| Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine | EXPERIMENTAL | - |
| Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV | EXPERIMENTAL | - |
| Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine | EXPERIMENTAL | - |
| Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV | EXPERIMENTAL | - |
| Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine | ACTIVE_COMPARATOR | - |
| Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CM-24 and Nivolumab - Dose Escalation | DRUG | Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors |
| CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion | DRUG | Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer |
| CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion | DRUG | Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer |
| Nivolumab, Nab paclitaxel and Gemcitabine - Expansion | DRUG | Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer |
| Nivolumab and Nal-IRI/5-FU/LV - Expansion | DRUG | Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer |
Inclusion Criteria: 1. Part A: Previously treated subjects with recurrent and/or metastatic NSCLC, pancreatic cancer, ovarian cancer, papillary thyroid cancer, colorectal adenocarcinoma and melanoma with documented progression/intolerance following at least one previous therapy (and not more than 2...
| 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 |
CM-24 and Nivolumab - Dose Escalation is a Phase 1 clinical study evaluating CM-24 given in combination with nivolumab in adults with advanced solid tumors. It is being developed by Purple Biotech Ltd. (ticker PPBT) as an oncology program. The trial enrolled 79 patients and has been completed.
It is being studied in adults with advanced solid tumors, including non-small cell lung cancer, pancreatic cancer, ovarian cancer, papillary thyroid cancer, melanoma, and colorectal adenocarcinoma. The study enrolled patients 18 years and older across sites in the United States, Israel, and Spain.
Purple Biotech Ltd., which trades under the ticker PPBT, is the developer of CM-24 and Nivolumab - Dose Escalation. The program combines CM-24 with nivolumab and was evaluated in a single Phase 1 study in advanced solid tumors.
CM-24 and Nivolumab - Dose Escalation is in Phase 1. The program's only listed trial, NCT04731467, is a completed Phase 1 study, and no active trials are currently recorded for this asset. It is an investigational combination and is not described as approved.
The program has been studied in one trial, NCT04731467, titled A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors. That Phase 1 trial is completed, enrolled 79 participants, was active-controlled and randomized, and did not use double blinding.