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Solid TumorPhase 1/2NCT04731467

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

A Phase 1/2 study testing CM-24 and Nivolumab - Dose Escalation, CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion and CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion in people with Solid Tumor and Non Small Cell Lung Cancer, run by Famewave Ltd. at 18 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CM-24 and Nivolumab - Dose Escalation, CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion and CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
18 sitesin 3 countries
Study dates
19 Mar 2021to 30 Sep 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 previous regimens); Part C: Subjects with histologically confirmed advanced metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines; Subjects with islet cell neoplasms are excluded; subjects with a maximum of 1 prior treatment regimen for metastatic disease excluding: nab-paclitaxel containing regimens and up to 8 weeks from last chemotherapy treatment (Arm #1); fluoropyrimidine or irinotecan containing regimens and up to 8 weeks from last chemotherapy treatment (Arm #2).
  • Part C, D: Subjects with histologically confirmed advanced metastatic pancreatic adenocarcinoma as defined by NCCN Guidelines; Subjects with islet cell neoplasms are excluded.
  • Parts C, D: Subjects who have progressed on or after standard of care chemotherapy with a maximum of 1 prior treatment regimen for advanced metastatic disease:
  • Subjects enrolled in arm with gemcitabine/nab-paclitaxel combination should have received a fluoropyrimidine and/or irinotecan containing regimen in the first line of treatment; Prior gemcitabine containing regimen may be allowed only if completed at least 6 months prior to study enrollment.
  • Arm #2: Subjects enrolled in arm with Nal-IRI/5FU/LV combination should have received a gemcitabine and/or nab-paclitaxel containing regimen in the first line of treatment; Prior irinotecan and/or fluoropyrimidine containing regimens may be allowed only if completed at least 6 months prior to study enrollment.
  • Part A: Availability of an archival tumor sample prior to first treatment. Parts C, D: Fresh tumor biopsy must be obtained within 3 months prior to enrollment and after the last systemic treatment was completed.
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  • Must have at least 1 measurable lesion per RECIST1.1 with progressing or new tumors since last antitumor therapy;
  • ECOG performance status score of 0 or 1;
  • Adequate safety lab results;
  • Stable brain metastases;
  • WCBP (Women of Childbearing Potential) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test, WCBP must agree to abstain from sex or use an adequate method of contraception, males must abstain from sex with WCBP or use an adequate method of contraception.

Who cannot join

  • Part A: Received more than two prior systemic regimens for the metastatic disease Parts C and D: Received more than 1 prior systemic regimens for the advanced metastatic disease
  • Part A: History of weight loss >10% over the 2 months prior to Screening;
  • Unresolved AEs > Grade 1 from prior anticancer therapy.
  • Concurrent malignancy requiring treatment;
  • Active, untreated central nervous system (CNS) metastases;
  • Subjects previously treated with an anti PD-1/PD-L1 targeting agent with history immune mediated toxicity;
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  • Severely immunocompromised;
  • History of allergy or hypersensitivity to any of the study treatment components;
  • Major surgery within 4 weeks of study administration;
  • Received a live / attenuated vaccine within 30 days of first treatment
  • Clinically relevant serious co-morbid medical conditions including, but not limited to:
  • Active infection;
  • Recent (within six months of Screening) cardiac disease, myocardial infarction, or severe or unstable angina;
  • History of serious arrhythmia;
  • Chronic obstructive or chronic restrictive pulmonary disease, pulmonary hypertension history of or active interstitial lung disease or pneumonitis;
  • Prior organ allograft;
  • Subjects with active, known or suspected autoimmune disease;
  • History of active or latent tuberculosis infection;
  • Positive test for HIV, HBV, or HCV;
  • Radiation within two weeks prior to the first study treatment;
  • Treatment with another investigational therapy within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
  • Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to treatment;
  • Pregnant or lactating women.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

Spain11 sites

  • Hospital Clinic Barcelona

    Barcelona

  • NEXT Oncology Barcelona

    Barcelona

  • Vall d' Hebron Institute of Oncology (VHIO)

    Barcelona

  • Clinica Universidad de Navarra

    Madrid

  • Hospital 12 Octubre

    Madrid

  • Hospital General Universitario Gregorio Maranon

    Madrid

  • Hospital South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

    Madrid

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    Madrid

  • Clinica Universidad de Navarra - Pamplona

    Pamplona

  • NEXT Oncology Madrid

    Pozuelo de Alarcón

  • Hospital Quiron Salud Valencia

    Valencia

Other trials in Spain

United States5 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Yale University

    New Haven, Connecticut, 06520

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

Israel2 sites

  • Rambam Health Care Campus

    Haifa

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

About this study

Official title: 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

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.

Being tested
CM-24 and Nivolumab - Dose Escalation, CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion, CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion, Nivolumab and Nal-IRI/5-FU/LV - Expansion
Keywords
CM24, nivolumab, Opdivo, nab-paclitaxel, Abraxane
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Ovarian Neoplasms, Thyroid Cancer, Papillary, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM-24 and Nivolumab - Dose EscalationDrug

    Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors

  • CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - ExpansionDrug

    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 - ExpansionDrug

    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 - ExpansionDrug

    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 - ExpansionDrug

    Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer

Study groups in NCT04731467
Study groupRoleWhat they receive
Part A- Dose escalation of CM24 in combination with nivolumabExperimentalNot described
Receives: Drug: CM-24 and Nivolumab - Dose Escalation
Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineExperimentalNot described
Receives: Drug: CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion
Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVExperimentalNot described
Receives: Drug: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion
Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineExperimentalNot described
Receives: Drug: CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion
Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVExperimentalNot described
Receives: Drug: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion
Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabineActive comparatorNot described
Receives: Drug: Nivolumab, Nab paclitaxel and Gemcitabine - Expansion
Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LVActive comparatorNot described
Receives: Drug: Nivolumab and Nal-IRI/5-FU/LV - Expansion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of treatment emergent adverse events

    Incidence of treatment emergent adverse events with CM-24 and nivolumab in adults with selected recurrent or metastatic solid tumors

    Measured: Up to 24 months

  2. Part C: Safety and tolerability

    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

    Measured: Up to 24 months

  3. Part D: Overall survival

    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.

    Measured: Up to 24 months

Secondary outcomes (24)

  1. Maximum serum concentration [Cmax]

    Maximum serum concentration [Cmax] of CM24

    Measured: Up to 24 months

  2. Time of maximum concentration [Tmax]

    Time of maximum concentration [Tmax] of CM24

    Measured: Up to 24 months

  3. Area under the serum concentration curve [AUC]

    Area under the serum concentration curve [AUC] of CM24

    Measured: Up to 24 months

  4. Half life

    Half life of CM24

    Measured: Up to 24 months

  5. Drug clearance

    Drug clearance of CM24

    Measured: Up to 24 months

  6. Volume of distribution

    Volume of distribution of CM24

    Measured: Up to 24 months

  7. Serum ADA parameters

    Serum ADA parameters of CM24 as measured by percentage of patients who are positive for the presence of anti-drug antibodies

    Measured: Up to 24 months

  8. Objective Response Rate when CM24 is used in combination with nivolumab

    Measured: Up to 24 months

  9. Disease Control Rate when CM24 is used in combination with nivolumab

    Measured: Up to 24 months

  10. Median Duration of Response when CM24 is used in combination with nivolumab

    Measured: Up to 24 months

  11. Median Time to Response when CM24 is used in combination with nivolumab

    Measured: Up to 24 months

  12. Progression Free Survival when CM24 is used in combination with nivolumab

    Measured: Up to 48 months

  13. Overall Survival when CM24 is used in combination with nivolumab

    Measured: Up to 48 months

  14. Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the maximum plasma concentration [Cmax]

    Measured: Up to 24 months

  15. Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the average area under the concentration curve [AUC]

    Measured: Up to 24 months

  16. Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the median area under the concentration curve [AUC]

    Measured: Up to 24 months

  17. Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the maximum plasma concentration [Cmax]

    Measured: Up to 24 months

  18. Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the average area under the concentration curve [AUC]

    Measured: Up to 24 months

  19. Population pharmacokinetics when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the median area under the concentration curve [AUC]

    Measured: Up to 24 months

  20. Disease Control Rate when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV

    Measured: Up to 24 months

  21. Duration of Response when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV

    Measured: Up to 24 months

  22. Time to Response when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV

    Measured: Up to 24 months

  23. Progression Free Survival when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV

    Measured: Up to 48 months

  24. Overall Survival when CM24 is used in combination with nivolumab and gemcitabin/nab-paclitaxel or Nal-IRI/5-FU/LV

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2021
  2. Study start19 Mar 2021
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04731467
Sponsor's protocol ID
FW-2020-1
Status last verified
Jun 2024
First submitted
24 Jan 2021
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CM-24 and Nivolumab - Dose Escalation, CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion and CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion in people with Solid Tumor and Non Small Cell Lung Cancer, run by Famewave Ltd. at 18 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain, United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of treatment emergent adverse events (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04731467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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