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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

CM-24 and Nivolumab- Dose Escalation · 1 trial · 7 indications

Phase 1 1
NCT04731467A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid TumorsSolid Tumor
COMPLETED79 Analytics
PHASE1COMPLETED
A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors
Solid TumorUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about CM-24 and Nivolumab- Dose Escalation

What is CM-24 and Nivolumab- Dose Escalation used for?

CM-24 and Nivolumab- Dose Escalation is used for the treatment of solid tumors, including non-small cell lung cancer, pancreatic cancer, ovarian cancer, papillary thyroid cancer, melanoma, and colorectal adenocarcinoma. It is being studied in adults with advanced solid tumors.

Who makes CM-24 and Nivolumab- Dose Escalation?

CM-24 and Nivolumab- Dose Escalation is being developed by Purple Biotech Ltd., which trades under the ticker PPBT. The combination therapy is being studied in a Phase 1 clinical trial.

What phase is CM-24 and Nivolumab- Dose Escalation in?

CM-24 and Nivolumab- Dose Escalation is in Phase 1 clinical development. The trial has been completed, and the drug combination remains investigational, meaning it has not been approved by regulatory authorities.

What clinical trials is CM-24 and Nivolumab- Dose Escalation in?

CM-24 and Nivolumab- Dose Escalation is associated with one clinical trial, NCT04731467, titled 'A Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors.' This Phase 1 study enrolled 79 participants and has been completed.

Is CM-24 and Nivolumab- Dose Escalation the same as CM-24?

CM-24 and Nivolumab- Dose Escalation is a combination therapy that includes CM-24 and nivolumab. The trial specifically studies the dose escalation of this combination in patients with advanced solid tumors.