Clinical Trials /

A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors

NCT04452214

Description:

This study will consider the safety and effectiveness of a study drug, CAN04, in combination with pembrolizumab, in the treatment of incurable or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. The study aims to establish a recommended dose of CAN04 in combination with the standard dose of pembrolizumab. Both CAN04 and pembrolizumab will be administered intravenously.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors
  • Official Title: An Open-label, Safety and Tolerability Phase 1b Trial of CAN04, a Fully Humanized Anti-IL1RAP Monoclonal Antibody, in Combination With Pembrolizumab in Subjects With Solid Tumors Progressing on PD-1/PD-L1 Inhibitor-containing Regimens

Clinical Trial IDs

  • ORG STUDY ID: CAN04CLIN002
  • NCT ID: NCT04452214

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Urothelial Carcinoma
  • Malignant Melanoma
  • Head and Neck Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
CAN04CAN04 and pembrolizumab
PembrolizumabCAN04 and pembrolizumab

Purpose

This study will consider the safety and effectiveness of a study drug, CAN04, in combination with pembrolizumab, in the treatment of incurable or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. The study aims to establish a recommended dose of CAN04 in combination with the standard dose of pembrolizumab. Both CAN04 and pembrolizumab will be administered intravenously.

Trial Arms

NameTypeDescriptionInterventions
CAN04 and pembrolizumabExperimentalSubjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen
  • CAN04
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects with metastatic or locally advanced, incurable non-small-cell lung cancer
             (NSCLC [adenocarcinoma, adenosquamous, or squamous]), head and neck squamous cell
             carcinoma (HNSCC), urothelial cancer, or malignant melanoma who have exhausted or
             declined available standard therapy.

          -  Subjects progressing on previous treatment with a checkpoint inhibitor targeting
             thePD-1/PD-L1 pathway, alone or in combination with chemotherapy after previously
             having achieved stable disease or better and stayed on such therapy for ≥12 weeks.

          -  Primary or metastatic lesion suitable for biopsy and willingness to undergo repeat
             biopsies as appropriate.

          -  Willing and able to provide intravenous access for the administration of the study
             drug and for blood sampling/testing.

        Exclusion Criteria:

          -  Subjects with NSCLC tumors with genetic alteration or mutation, for which FDA-approved
             targeted therapy is available.

          -  Treatment with systemic anticancer treatments, investigational products, or major
             surgery within 4 weeks before first dose of study drug or 5 half-lives, whichever is
             shorter. Subjects should have recovered from previous treatment toxicity (except hair
             loss and peripheral neuropathy).

          -  History of uncontrolled brain metastasis.

          -  Subject has received extended field radiotherapy ≤4 weeks before the start of
             treatment (≤2 weeks for limited field radiation to alleviate symptoms), and who has
             not recovered from related side effects of such therapy (except for hair loss).

          -  Subjects who have previously experienced an immune-related adverse event (irAE) to
             pembrolizumab, for which permanent discontinuation is required. Subjects without a
             formal contraindication due to previous irAE are not eligible if the AE has not
             resolved or requires steroids (>10 mg prednisone-equivalent per day) for ongoing
             management.

          -  Subjects with active severe infection requiring oral antibiotics.

          -  Clinical evidence of an active second invasive malignancy with the exception of stable
             prostate cancer on watchful waiting.

          -  Uncontrolled or significant cardiovascular disease.

          -  History of autoimmune disease requiring systemic immunosuppressive therapy (daily
             prednisone equivalent doses >10 mg/day).

          -  HIV patients can be enrolled if the infection is adequately controlled.

          -  Known bleeding disorder or coagulopathy. Subjects on stable anticoagulant therapy are
             allowed.

          -  Known or suspected allergy to study treatment or related products.

          -  Women who are pregnant or breastfeeding, or trying to become pregnant.

          -  Patients with chronic viral hepatitis.

        Other protocol-defined inclusion/exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Frequency of TEAEs (treatment-emergent adverse events)
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Serum concentrations of CAN04 and pembrolizumab
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:
Measure:Antidrug antibodies (ADAs) against CAN04
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:
Measure:Change in serum IL-6 (interleukin-6) concentration
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:
Measure:Change in serum CRP (C-reactive protein) concentration
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:
Measure:Overall response rate (ORR)
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan)
Measure:Progression free survival
Time Frame:From the first dose until the last subject hast completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 36 months after 1st dose of last subject (or death)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Cantargia AB

Trial Keywords

  • NSCLC
  • Adenocarcinoma of lung
  • Lung cancer
  • Squamous cell lung cancer
  • Malignant melanoma
  • Urothelial cancer
  • Non-small-cell lung cancer
  • Non small cell lung cancer
  • Non-small-cell lung carcinoma
  • Non small cell lung carcinoma
  • HNSCC
  • Head and neck squamous cell carcinoma

Last Updated

June 28, 2020