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Monoclonal Antibodies

CM24 + Nivolumab for Solid Tumors

Phase 1 & 2
Waitlist Available
Research Sponsored by Famewave Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 previous regimens)
Subjects with histologically confirmed advanced metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug (CM-24) in combination with another drug (nivolumab) to see if it is safe and works well against advanced solid tumors, non-small cell lung cancer, and pancreatic cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood disorders that can affect cell counts and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or spread, and I've had 1-2 treatments but they didn't work or caused side effects.
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My cancer is advanced pancreatic cancer, confirmed by tests.
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My cancer has worsened after 1 treatment for advanced disease.
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I have had a recent biopsy after my last cancer treatment.
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I have at least one tumor that can be measured and has grown since my last cancer treatment.
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I am fully active or can carry out light work.
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My brain cancer has not changed recently.
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I am not pregnant and agree to use birth control or abstain from sex.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence of treatment emergent adverse events
Part C: Safety and tolerability
Part D: Overall survival
Secondary outcome measures
Area under the serum concentration curve [AUC]
Disease Control Rate when CM24 is used in combination with nivolumab
Disease Control Rate when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV
+21 more

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineExperimental Treatment1 Intervention
Group II: Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVExperimental Treatment1 Intervention
Group III: Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineExperimental Treatment1 Intervention
Group IV: Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVExperimental Treatment1 Intervention
Group V: Part A- Dose escalation of CM24 in combination with nivolumabExperimental Treatment1 Intervention
Group VI: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabineActive Control1 Intervention
Group VII: Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LVActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Famewave Ltd.Lead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,222 Total Patients Enrolled
Michael Schickler, PhDStudy DirectorFamewave Ltd.
1 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

CM-24 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04731467 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine, Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV, Part A- Dose escalation of CM24 in combination with nivolumab, Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine, Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV, Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine, Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV
Colorectal Cancer Clinical Trial 2023: CM-24 Highlights & Side Effects. Trial Name: NCT04731467 — Phase 1 & 2
CM-24 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731467 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical purposes are CM-24 and Nivolumab - Dose Escalation typically used?

"Traditionally, CM-24 and Nivolumab - Dose Escalation have been prescribed to treat unresectable melanoma. Nonetheless, this therapy has become increasingly popular for individuals with squamous cell carcinoma as well as those at a greater risk of recurrence or disease progression."

Answered by AI

Are there any previous investigations that have explored the efficacy of combining CM-24 and Nivolumab in increasing doses?

"Currently, there are 1,504 active clinical trials exploring CM-24 and Nivolumab - Dose Escalation. Of these studies, 298 are in Phase 3. Shanghai is one of the 77,770 locales where research into CM-24 and Nivolumab - Dose Escalation is being conducted."

Answered by AI

How many individuals can participate in this research project?

"This study requires 80 participants that satisfy the listed inclusion criteria. The HonorHealth Research Institute in Scottsdale, Arizona and Yale University in New Haven, Connecticut are two of many possible locations for potential enrollees."

Answered by AI

Are there a multitude of locations in Canada that are conducting this experiment?

"Patients can participate in this clinical trial at HonorHealth Research Institute, located in Scottsdale Arizona; Yale University situated in New Haven, Connecticut; and The University of Texas M.D. Anderson Cancer Center based out of Houston, Texas along with four additional sites."

Answered by AI

Are there available vacancies for participants in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively enrolling participants and has been since March 19th 2021; the report was last modified on April 25th 2022."

Answered by AI
~20 spots leftby Mar 2025