CM24 + Nivolumab for Solid Tumors

Recruiting at 19 trial locations

Overseen By Hadas Nachmanson

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Famewave Ltd.

Must not be taking: Anti PD-1/PD-L1 agents

Disqualifiers: Active infection, Cardiac disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

79 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of new and existing drugs to treat patients with severe forms of cancer. The treatment aims to boost the immune system's ability to fight cancer and directly kill cancer cells.

Research Team

Michael Schickler, PhD

Principal Investigator

Famewave Ltd.

Eligibility Criteria

Adults with certain advanced solid tumors or metastatic pancreatic cancer, who have tried at least one but no more than two previous therapies. They must have a measurable tumor, stable brain metastases if present, and be in good physical condition (ECOG score of 0 or 1). Women able to bear children and men must agree to use contraception.

Inclusion Criteria

I have had a recent biopsy after my last cancer treatment.

I have at least one tumor that can be measured and has grown since my last cancer treatment.

My cancer is advanced pancreatic cancer, confirmed by tests.

Exclusion Criteria

I had side effects from previous immunotherapy targeting PD-1/PD-L1.

My immune system is very weak.

I have had more than two treatments for my cancer after it spread.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CM24 in combination with nivolumab, with additional chemotherapy agents in certain parts of the study

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• CM-24
• Gemcitabine
• Nab paclitaxel
• Nal-IRI
• Nivolumab

Trial Overview The trial is testing the safety and effectiveness of CM-24 combined with nivolumab, sometimes along with other chemotherapy drugs like Nab paclitaxel/Gemcitabine or Nal-IRI/5-FU/LV. It's an open-label study where everyone knows what treatment they're getting.

Participant Groups

Group I: Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine Experimental Treatment 1 Intervention

Group II: Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV Experimental Treatment 1 Intervention

Group III: Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine Experimental Treatment 1 Intervention

Group IV: Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV Experimental Treatment 1 Intervention

Group V: Part A- Dose escalation of CM24 in combination with nivolumab Experimental Treatment 1 Intervention

Group VI: Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV Active Control 1 Intervention

Group VII: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine Active Control 1 Intervention

Who Is Running the Clinical Trial?

Famewave Ltd.

Lead Sponsor

Trials

2

Recruited

110+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania