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BRIEF TITLE: Anti-IL1RAP Monoclonal Antibody, in Combination With Pembrolizumab in Subjects With Solid Tumors Progressing on PD-1/PD-L1 Inhibitor-containing Regimens

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


  • Org Study ID: CAN04CLIN002
  • Secondary ID:
  • NCT ID: NCT04452214
  • NCT Alias:
  • Sponsor: Cantargia AB - Industry
  • Source: Cantargia AB

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.

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

Primary Outcomes:

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

Primary Outcome 1 - 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

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

Primary Outcome 2 - Time Frame: Up to day 28

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

Primary Outcome 3 - 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

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

Primary Outcome 4 - 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

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

Primary Outcome 5 - 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

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

Primary Outcome 6 - 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

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

Primary Outcome 7 - 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

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

Primary Outcome 8 - 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

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

Primary Outcome 9 - 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

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

Primary Outcome 10 - 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

Condition:

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

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.
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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

Link: FDA Safety Alerts and Recalls

Locations

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