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A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors

NCT04731467 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2024-12-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Michael Schickler, PhD · Famewave Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-19
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04731467 on ClinicalTrials.gov