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

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ClinicalTrials.gov Identifier: NCT04452214
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cantargia AB

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Urothelial Carcinoma Malignant Melanoma Head and Neck Squamous Cell Carcinoma Drug: CAN04 Drug: Pembrolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CAN04 and pembrolizumab
Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen
 Drug: CAN04
Administered intravenously

Drug: Pembrolizumab
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of participants with DLTs (dose-limiting toxicities) [ Time Frame: Up to day 28 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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)

  6. 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 ]
  7. Overall survival [ Time Frame: Up to 36 months after 1st dose of last subject (or death) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452214


Contacts
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Contact: Ignacio Garcia-Ribas, MD, PhD +34 649 450384 ignacio.garcia-ribas@cantargia.com
Contact: Marie Wallén Öhman marie.wallen-ohman@cantargia.com

Locations
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United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Manager    720-848-0676    paula.fisk@cuanschutz.edu   
United States, Florida
Florida Cancer Specialists & Research Institute Recruiting
Lake Mary, Florida, United States, 32746
Contact: Study Coordinator    407-804-6133    ajackson@flcancer.com   
United States, Pennsylvania
Hospital of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-5127
Contact: Site Manager    215-220-9703    Melissa.Volpe@pennmedicine.upenn.edu   
Sponsors and Collaborators
Cantargia AB
Investigators
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Study Director: Ignacio Garcia-Ribas, MD, PhD Chief Medical Officer, Cantargia AB
More Information
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Additional Information:

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Responsible Party: Cantargia AB
ClinicalTrials.gov Identifier: NCT04452214    
Other Study ID Numbers: CAN04CLIN002
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cantargia AB:
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
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents