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

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

INTRODUCTION

  • Org Study ID: CAN04CLIN002
  • Secondary ID: N/A
  • NTC ID: NCT04452214
  • Sponsor: Cantargia AB
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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.

  • Overall Status
    Recruiting
  • Start Date
    September 24, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Frequency of TEAEs (treatment-emergent adverse events)

Primary Outcome 1 - Timeframe: 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

Primary Outcome 2 - Measure: Number of participants with DLTs (dose-limiting toxicities)

Primary Outcome 2 - Timeframe: Up to day 28

Primary Outcome 3 - Measure: Number of subjects with grade ≥3 TEAEs

Primary Outcome 3 - Timeframe: 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

Primary Outcome 4 - Measure: Percentage of subjects with grade ≥3 TEAEs

Primary Outcome 4 - Timeframe: 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

Primary Outcome 5 - Measure: Number of subjects with 1 or more SAEs (serious adverse events)

Primary Outcome 5 - Timeframe: 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

Primary Outcome 6 - Measure: Percentage of subjects with 1 or more SAEs

Primary Outcome 6 - Timeframe: 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

Primary Outcome 7 - Measure: Number of subjects with 1 or more TEAEs leading to dose modifications

Primary Outcome 7 - Timeframe: 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

Primary Outcome 8 - Measure: Number of subjects with 1 or more TEAEs leading to treatment discontinuation

Primary Outcome 8 - Timeframe: 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

Primary Outcome 9 - Measure: Percentage of subjects with 1 or more TEAEs leading to dose modifications

Primary Outcome 9 - Timeframe: 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

Primary Outcome 10 - Measure: Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation

Primary Outcome 10 - Timeframe: 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

CONDITION

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

ELIGIBILITY

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Ignacio Garcia-Ribas, MD, PhD

Role: Study Director

Affiliation: Chief Medical Officer, Cantargia AB

Overall Contact

Name: Ignacio Garcia-Ribas, MD, PhD

Phone: +34 649 450384

Email: ignacio.garcia-ribas@cantargia.com, marie.wallen-ohman@cantargia.com

LOCATION

Facility Status Contact
Facility: University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Site Manager
720-848-0676
paula.fisk@cuanschutz.edu
Facility: Florida Cancer Specialists & Research Institute
Lake Mary, Florida 32746
United States
Status: Recruiting Contact: Contact
Study Coordinator
407-804-6133
ajackson@flcancer.com
Facility: Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania 19104-5127
United States
Status: Recruiting Contact: Contact
Site Manager
215-220-9703
Melissa.Volpe@pennmedicine.upenn.edu