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.
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
Drug | Synonyms | Arms |
---|
CM-24 and Nivolumab - Dose Escalation | | Dose escalation of CM24 in combination with nivolumab |
CM-24 and Nivolumab - Expansion | | Expansion cohort of CM24 in combination with nivolumab |
CM-24, Nivolumab, and Nab paclitaxel - Expansion | | Expansion 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
Name | Type | Description | Interventions |
---|
Dose escalation of CM24 in combination with nivolumab | Experimental | | - CM-24 and Nivolumab - Dose Escalation
|
Expansion cohort of CM24 in combination with nivolumab | Experimental | | - CM-24 and Nivolumab - Expansion
|
Expansion cohort of CM24 in combination with nivolumab and nab-paclitaxel | Experimental | | - 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
July 29, 2021