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Phase I

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

  • Study HIC#:2000029869
  • Last Updated:06/15/2022

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.

  • Start Date06/14/2022
  • End Date02/05/2024

Trial Purpose and Description

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

Eligibility 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.

For more information about this study, contact: