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Trial record 1 of 1 for:    FW2020-1
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A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04731467
Recruitment Status : Active, not recruiting
First Posted : February 1, 2021
Last Update Posted : April 4, 2024
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) 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.

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, Nivolumab, Nab paclitaxel and Gemcitabine - Expansion Drug: CM-24, Nivolumab, and Nal-IRI/5-FU/LV - Expansion Drug: Nivolumab, Nab paclitaxel and Gemcitabine - Expansion Drug: 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 : 79 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Masking Description: Parts A and C are non-randomized parts, part D is a randomized part.
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 : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A- Dose escalation of CM24 in combination with nivolumab Drug: CM-24 and Nivolumab - Dose Escalation
Dose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors
Experimental: Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine 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
Experimental: Part C- 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 advanced metastatic pancreatic cancer
Experimental: Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine 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
Experimental: Part D- 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 advanced metastatic pancreatic cancer
Active Comparator: Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine 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
Active Comparator: Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV 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


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 C: Safety and tolerability [ Time Frame: Up to 24 months ]
    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

  3. Part D: Overall survival [ Time Frame: Up to 24 months ]
    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.


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 gemcitabin/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 gemcitabin/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 gemcitabin/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 gemcitabin/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 gemcitabin/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 gemcitabin/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 gemcitabin/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 gemcitabin/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

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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); 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.

  2. 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.
  3. 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.
  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 Parts C and D: Received more than 1 prior systemic regimens for the advanced metastatic disease
  2. Part A: History of weight loss >10% over the 2 months prior to Screening;
  3. Unresolved AEs > Grade 1 from prior anticancer therapy.
  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. Received a live / attenuated vaccine within 30 days of first treatment

  11. 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;
  12. Radiation within two weeks prior to the first study treatment;
  13. Treatment with another investigational therapy within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
  14. 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;
  15. 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


Locations
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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: April 4, 2024
Last Verified: April 2024
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 Cancer, Papillary
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Neoplasms
Head and Neck Neoplasms
Thyroid Diseases
Adenocarcinoma, Papillary
Paclitaxel
Albumin-Bound Paclitaxel
 Gemcitabine
Nivolumab
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Immunosuppressive Agents
Immunologic Factors