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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2022

Interventions

  • Drug: CAN04
    • Administered intravenously
  • Drug: Pembrolizumab
    • Administered intravenously

Arms, Groups and Cohorts

  • Experimental: CAN04 and pembrolizumab
    • Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Number of participants with DLTs (dose-limiting toxicities)
    • Time Frame: Up to day 28
  • Number of subjects with grade ≥3 TEAEs
    • 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
  • Percentage of subjects with grade ≥3 TEAEs
    • 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
  • Number of subjects with 1 or more SAEs (serious 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
  • Percentage of subjects with 1 or more SAEs
    • 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
  • Number of subjects with 1 or more TEAEs leading to dose modifications
    • 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
  • Number of subjects with 1 or more TEAEs leading to treatment discontinuation
    • 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
  • Percentage of subjects with 1 or more TEAEs leading to dose modifications
    • 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
  • Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation
    • 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

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
    • 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)
  • 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
  • Overall survival
    • Time Frame: Up to 36 months after 1st dose of last subject (or death)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cantargia AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ignacio Garcia-Ribas, MD, PhD, Study Director, Chief Medical Officer, Cantargia AB
  • Overall Contact(s)
    • Ignacio Garcia-Ribas, MD, PhD, +34 649 450384, ignacio.garcia-ribas@cantargia.com

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