Clinical Trials /

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

NCT04731467

Description:

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 will be administered subsequent to CM24 and nivolumab.

Related Conditions:
  • Colorectal Adenocarcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Adenocarcinoma
  • Pancreatic Carcinoma
  • Thyroid Gland Papillary Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of CM24 in Combination With Nivolumab in Adults With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: FW-2020-1
  • NCT ID: NCT04731467

Conditions

  • Solid Tumor
  • Non Small Cell Lung Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Papillary Thyroid Cancer
  • Melanoma
  • Colorectal Adenocarcinoma

Interventions

DrugSynonymsArms
CM-24 and Nivolumab - Dose EscalationDose escalation of CM24 in combination with nivolumab
CM-24 and Nivolumab - ExpansionExpansion cohort of CM24 in combination with nivolumab
CM-24, Nivolumab, and Nab paclitaxel - ExpansionExpansion cohort of CM24 in combination with nivolumab and nab-paclitaxel

Purpose

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 will be administered subsequent to CM24 and nivolumab.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation of CM24 in combination with nivolumabExperimental
  • CM-24 and Nivolumab - Dose Escalation
Expansion cohort of CM24 in combination with nivolumabExperimental
  • CM-24 and Nivolumab - Expansion
Expansion cohort of CM24 in combination with nivolumab and nab-paclitaxelExperimental
  • CM-24, Nivolumab, and Nab paclitaxel - Expansion

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
             could have had a maximum of 1 prior treatment regimen for metastatic disease excluding
             nab-paclitaxel containing regimens and up to 8 weeks from last chemotherapy treatment;
             nab-paclitaxel completed more than 6 months prior to study is allowed.

          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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part A: Incidence of treatment emergent adverse events
Time Frame:Up to 24 months
Safety Issue:
Description:Incidence of treatment emergent adverse events with CM-24 and nivolumab in adults with selected recurrent or metastatic solid tumors

Secondary Outcome Measures

Measure:Maximum serum concentration [Cmax]
Time Frame:Up to 24 months
Safety Issue:
Description:Maximum serum concentration [Cmax] of CM24
Measure:Time of maximum concentration [Tmax]
Time Frame:Up to 24 months
Safety Issue:
Description:Time of maximum concentration [Tmax] of CM24
Measure:Area under the serum concentration curve [AUC]
Time Frame:Up to 24 months
Safety Issue:
Description:Area under the serum concentration curve [AUC] of CM24
Measure:Half life
Time Frame:Up to 24 months
Safety Issue:
Description:Half life of CM24
Measure:Drug clearance
Time Frame:Up to 24 months
Safety Issue:
Description:Drug clearance of CM24
Measure:Volume of distribution
Time Frame:Up to 24 months
Safety Issue:
Description:Volume of distribution of CM24
Measure:Serum ADA parameters
Time Frame:Up to 24 months
Safety Issue:
Description:Serum ADA parameters of CM24 as measured by percentage of patients who are positive for the presence of anti-drug antibodies
Measure:Objective Response Rate when CM24 is used in combination with nivolumab
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Disease Control Rate when CM24 is used in combination with nivolumab
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Median Duration of Response when CM24 is used in combination with nivolumab
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Median Time to Response when CM24 is used in combination with nivolumab
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Progression Free Survival when CM24 is used in combination with nivolumab
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Overall Survival when CM24 is used in combination with nivolumab
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Population pharmacokinetics when CM24 is used in combination with nivolumab as measured by the maximum plasma concentration [Cmax]
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Population pharmacokinetics when CM24 is used in combination with nivolumab and nab-paclitaxel as measured by the maximum plasma concentration [Cmax]
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Population pharmacokinetics when CM24 is used in combination with nivolumab and nab-paclitaxel as measured by the average area under the concentration curve [AUC]
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Population pharmacokinetics when CM24 is used in combination with nivolumab and nab-paclitaxel as measured by the median area under the concentration curve [AUC]
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Disease Control Rate when CM24 is used in combination with nivolumab and nab-paclitaxel
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Duration of Response when CM24 is used in combination with nivolumab and nab-paclitaxel
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Time to Response when CM24 is used in combination with nivolumab and nab-paclitaxel
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Progression Free Survival when CM24 is used in combination with nivolumab and nab-paclitaxel
Time Frame:Up to 48 months
Safety Issue:
Description:
Measure:Overall Survival when CM24 is used in combination with nivolumab and nab-paclitaxel
Time Frame:Up to 48 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Famewave Ltd.

Trial Keywords

  • CM24
  • nivolumab
  • Opdivo
  • nab-paclitaxel
  • Abraxane

Last Updated

March 29, 2021