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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04731467
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : May 2, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Purple Biotech Ltd. ( Famewave Ltd. )

Study Description
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Brief Summary:
This is an open-label, multicenter, multi-dose escalation and dose expansion study in subjects with selected advanced solid tumors (Part A), advanced recurrent immune checkpoint refractory non-small cell lung cancer (NSCLC) (Part B), and metastatic pancreatic cancer (Part C) to evaluate the safety and tolerability of CM-24 in combination with nivolumab. In Part C of the study nab-paclitaxel or Nal-IRI/5FU/LV will be administered subsequent to CM24 and nivolumab.

Condition or disease Intervention/treatment Phase
Solid Tumor Non Small Cell Lung Cancer Pancreatic Cancer Ovarian Cancer Papillary Thyroid Cancer Melanoma Colorectal Adenocarcinoma Drug: CM-24 and Nivolumab - Dose Escalation Drug: CM-24 and Nivolumab - Expansion Drug: CM-24, Nivolumab, and Nab paclitaxel - Expansion Drug: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose escalation of CM24 in combination with nivolumab Drug: CM-24 and Nivolumab - Dose Escalation
Dose escalation of CM24 with nivolumab in adult subjects with selected recurrent or metastatic solid tumors
Experimental: Expansion cohort of CM24 in combination with nivolumab Drug: CM-24 and Nivolumab - Expansion
Expansion cohort of CM24 in combination with nivolumab in adult subjects with recurrent or metastatic immune checkpoint refractory non-small cell lung cancer
Experimental: Expansion cohort of CM24 in combination with nivolumab and nab-paclitaxel Drug: CM-24, Nivolumab, and Nab paclitaxel - Expansion
Expansion cohort of CM24 in combination with nivolumab and nab-paclitaxel in adult patients with metastatic pancreatic cancer
Experimental: Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV 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 metastatic pancreatic cancer


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Incidence of treatment emergent adverse events [ Time Frame: Up to 24 months ]
    Incidence of treatment emergent adverse events with CM-24 and nivolumab in adults with selected recurrent or metastatic solid tumors

  2. Part B: Objective Response Rate [ Time Frame: Up to 24 months ]
    Objective Response Rate when phase 2 dose of CM-24 is used in combination with nivolumab in adults with recurrent and/or metastatic non-small cell lung cancer

  3. Part C: Objective Response Rate [ Time Frame: Up to 24 months ]
    Objective Response Rate when phase 2 dose of CM-24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV in adults with metastatic pancreatic cancer


Secondary Outcome Measures :
  1. Maximum serum concentration [Cmax] [ Time Frame: Up to 24 months ]
    Maximum serum concentration [Cmax] of CM24

  2. Time of maximum concentration [Tmax] [ Time Frame: Up to 24 months ]
    Time of maximum concentration [Tmax] of CM24

  3. Area under the serum concentration curve [AUC] [ Time Frame: Up to 24 months ]
    Area under the serum concentration curve [AUC] of CM24

  4. Half life [ Time Frame: Up to 24 months ]
    Half life of CM24

  5. Drug clearance [ Time Frame: Up to 24 months ]
    Drug clearance of CM24

  6. Volume of distribution [ Time Frame: Up to 24 months ]
    Volume of distribution of CM24

  7. Serum ADA parameters [ Time Frame: Up to 24 months ]
    Serum ADA parameters of CM24 as measured by percentage of patients who are positive for the presence of anti-drug antibodies

  8. Objective Response Rate when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
  9. Disease Control Rate when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
  10. Median Duration of Response when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
  11. Median Time to Response when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
  12. Progression Free Survival when CM24 is used in combination with nivolumab [ Time Frame: Up to 48 months ]
  13. Overall Survival when CM24 is used in combination with nivolumab [ Time Frame: Up to 48 months ]
  14. Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the maximum plasma concentration [Cmax] [ Time Frame: 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] [ Time Frame: 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] [ Time Frame: Up to 24 months ]
  17. Population pharmacokinetics when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the maximum plasma concentration [Cmax] [ Time Frame: Up to 24 months ]
  18. Population pharmacokinetics when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the average area under the concentration curve [AUC] [ Time Frame: Up to 24 months ]
  19. Population pharmacokinetics when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV as measured by the median area under the concentration curve [AUC] [ Time Frame: Up to 24 months ]
  20. Disease Control Rate when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV [ Time Frame: Up to 24 months ]
  21. Duration of Response when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV [ Time Frame: Up to 24 months ]
  22. Time to Response when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV [ Time Frame: Up to 24 months ]
  23. Progression Free Survival when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV [ Time Frame: Up to 48 months ]
  24. Overall Survival when CM24 is used in combination with nivolumab and nab-paclitaxel or Nal-IRI/5-FU/LV [ Time Frame: Up to 48 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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);
  2. Part B: Subjects with histologically confirmed metastatic or locally advanced non-small cell lung cancer (NSCLC) with documented progression following anti-PD-1/PD-L1 containing therapy; Subjects must have confirmation of progression of disease that is consistent with iCPD during or within 3 months of prior anti-PD1/PDL1 with either two radiographic scans showing disease progression or documented clinical progression (e.g., worsening of symptoms); Subjects could have had a maximum of 1 prior treatment regimen;
  3. Part C: Subjects with histologically confirmed 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). .
  4. Must have at least 1 measurable lesion per RECIST1.1 with progressing or new tumors since last antitumor therapy;
  5. ECOG performance status score of 0 or 1;
  6. Adequate safety lab results;
  7. Stable brain metastases;
  8. 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.

Exclusion Criteria:

  1. Part A: Received more than two prior systemic regimens for the metastatic disease
  2. Part B and C: Received more than 1 prior systemic regimens for the advanced/recurrent and/or metastatic disease
  3. History of weight loss >10% over the 2 months prior to Screening;
  4. Concurrent malignancy requiring treatment;
  5. Active, untreated central nervous system (CNS) metastases;
  6. Subjects previously treated with an anti PD-1/PD-L1 targeting agent with history immune mediated toxicity;
  7. Severely immunocompromised;
  8. History of allergy or hypersensitivity to any of the study treatment components;
  9. Major surgery within 4 weeks of study administration;

  10. 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;
  11. Radiation within two weeks prior to the first study treatment;
  12. Treatment with another investigational therapy within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
  13. 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;
  14. Pregnant or lactating women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04731467


Contacts
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Contact: Michael Schickler, PhD +972 3 933 3121 trials@purple-biotech.com
Contact: Naomi Yama, RN, BSN +972 3 933 3121 trials@purple-biotech.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Anna Bermudez    480-323-1381    ABermudez@HonorHealth.com   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Talia Mitchell    203-785-6795    talia.mitchell@yale.edu   
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Tina Guthrie    313-576-9379    guthriet@karmanos.org   
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Shubham Pant, MD    713-563-1930    SPant@mdanderson.com   
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Liat Rapaport    04-777-6731    l_rapaport@rambam.health.gov.il   
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Ilanit Redinsky       Ilanit.Redinsky@sheba.health.gov.il   
Contact    03-530-4598      
Sponsors and Collaborators
Famewave Ltd.
Bristol-Myers Squibb
Investigators
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Study Director: Michael Schickler, PhD Famewave Ltd.
More Information
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Responsible Party: Famewave Ltd.
ClinicalTrials.gov Identifier: NCT04731467    
Other Study ID Numbers: FW-2020-1
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Purple Biotech Ltd. ( Famewave Ltd. ):
CM24
nivolumab
Opdivo
nab-paclitaxel
Abraxane
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Cancer, Papillary
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Thyroid Diseases
 Adenocarcinoma, Papillary
Paclitaxel
Nivolumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors