A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT04731467 |
Recruitment Status :
Recruiting
First Posted : February 1, 2021
Last Update Posted : May 2, 2022
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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 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 |

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 |
- 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
- 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
- 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
- Maximum serum concentration [Cmax] [ Time Frame: Up to 24 months ]Maximum serum concentration [Cmax] of CM24
- Time of maximum concentration [Tmax] [ Time Frame: Up to 24 months ]Time of maximum concentration [Tmax] of CM24
- Area under the serum concentration curve [AUC] [ Time Frame: Up to 24 months ]Area under the serum concentration curve [AUC] of CM24
- Half life [ Time Frame: Up to 24 months ]Half life of CM24
- Drug clearance [ Time Frame: Up to 24 months ]Drug clearance of CM24
- Volume of distribution [ Time Frame: Up to 24 months ]Volume of distribution of CM24
- 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
- Objective Response Rate when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
- Disease Control Rate when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
- Median Duration of Response when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
- Median Time to Response when CM24 is used in combination with nivolumab [ Time Frame: Up to 24 months ]
- Progression Free Survival when CM24 is used in combination with nivolumab [ Time Frame: Up to 48 months ]
- Overall Survival when CM24 is used in combination with nivolumab [ Time Frame: Up to 48 months ]
- Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the maximum plasma concentration [Cmax] [ Time Frame: Up to 24 months ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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;
- 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). .
- 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.
Exclusion Criteria:
- Part A: Received more than two prior systemic regimens for the metastatic disease
- Part B and C: Received more than 1 prior systemic regimens for the advanced/recurrent and/or metastatic disease
- History of weight loss >10% over the 2 months prior to Screening;
- 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;
- Severely immunocompromised;
- History of allergy or hypersensitivity to any of the study treatment components;
- Major surgery within 4 weeks of study administration;
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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.

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
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 |
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 |
Study Director: | Michael Schickler, PhD | Famewave Ltd. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CM24 nivolumab Opdivo nab-paclitaxel Abraxane |
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 |