Trials / Completed
CompletedNCT04731467
A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors
A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Famewave Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter, multi-dose escalation and dose expansion study in subjects with selected advanced solid tumors (Part A) and advanced metastatic pancreatic cancer (Parts C \& D) to evaluate the safety and tolerability of CM-24 in combination with nivolumab. In Part C of the study gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV will be administered subsequent to CM24 and nivolumab. CM24, nivolumab and gemcitabine/nab-paclitaxel or Nal-IRI/5-FU/LV are administered intravenously.
Conditions
- Solid Tumor
- Non Small Cell Lung Cancer
- Pancreatic Cancer
- Ovarian Cancer
- Papillary Thyroid Cancer
- Melanoma
- Colorectal Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CM-24 and Nivolumab - Dose Escalation | Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors |
| DRUG | CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion | Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer |
| DRUG | CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion | Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer |
| DRUG | Nivolumab, Nab paclitaxel and Gemcitabine - Expansion | Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer |
| DRUG | Nivolumab and Nal-IRI/5-FU/LV - Expansion | Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer |
Timeline
- Start date
- 2021-03-19
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
- First posted
- 2021-02-01
- Last updated
- 2024-12-27
Locations
18 sites across 3 countries: United States, Israel, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04731467. Inclusion in this directory is not an endorsement.