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CM-24 and Nivolumab - Dose Escalation

Phase 1

Solid Tumor | Small molecule | Oncology |Purple Biotech Ltd.|Last Updated: Dec 27, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04731467A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid TumorsPHASE1 COMPLETED 79Mar 19, 2021Sep 30, 2024Dec 27, 202418 United States, Israel +1
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Study Endpoints
Primary Endpoints
Part A: Incidence of treatment emergent adverse events
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 C: Safety and tolerability
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

Part D: Overall survival
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 Endpoints
Maximum serum concentration [Cmax]
Up to 24 months
Time of maximum concentration [Tmax]
Up to 24 months
Area under the serum concentration curve [AUC]
Up to 24 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A- Dose escalation of CM24 in combination with nivolumabEXPERIMENTAL -
Part C- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineEXPERIMENTAL -
Part C- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVEXPERIMENTAL -
Part D- Expansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabineEXPERIMENTAL -
Part D- Expansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LVEXPERIMENTAL -
Part D- Expansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabineACTIVE_COMPARATOR -
Part D- Expansion cohort of nivolumab in combination with Nal-IRI/5-FU/LVACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CM-24 and Nivolumab - Dose EscalationDRUGDose escalation of CM24 with nivolumab in adult patients with selected recurrent or metastatic solid tumors
CM-24, Nivolumab, Nab paclitaxel and Gemcitabine - ExpansionDRUGExpansion cohort of CM24 in combination with nivolumab, nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
CM-24, Nivolumab, and Nal-IRI/5-FU/LV - ExpansionDRUGExpansion cohort of CM24 in combination with nivolumab and Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
Nivolumab, Nab paclitaxel and Gemcitabine - ExpansionDRUGExpansion cohort of nivolumab in combination with nab-paclitaxel and gemcitabine in adult patients with advanced metastatic pancreatic cancer
Nivolumab and Nal-IRI/5-FU/LV - ExpansionDRUGExpansion cohort of nivolumab in combination with Nal-IRI/5-FU/LV in adult patients with advanced metastatic pancreatic cancer
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

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...

Countries:United StatesIsraelSpain
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