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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, and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors

INTRODUCTION

  • Org Study ID: CAN04CLIN002
  • Secondary ID: N/A
  • NTC ID: NCT04452214
  • Sponsor: Cantargia AB
FDA Safety Alerts and Recalls, FDA Recalls, Market Withdrawals, and Safety Alerts

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 (NSCLC), 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 (Part 1), and in combination with pembrolizumab standard dose, and Standard of Care carboplatin and pemetrexed (Part 2 - subjects with stage IV, non-squamous metastatic NSCLC). CAN04, pembrolizumab. carboplatin and pemetrexed 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) (Part 1)

Primary Outcome 1 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 2 - Measure: Frequency of TEAEs (treatment-emergent adverse events) (Part 2)

Primary Outcome 2 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 3 - Measure: Number of participants with DLTs (dose-limiting toxicities) (Part 1)

Primary Outcome 3 - Timeframe: Up to day 28

Primary Outcome 4 - Measure: Number of participants with DLTs (dose-limiting toxicities) (Part 2)

Primary Outcome 4 - Timeframe: Up to day 28

Primary Outcome 5 - Measure: Number of subjects with grade ≥3 TEAEs (Part 1)

Primary Outcome 5 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 6 - Measure: Number of subjects with grade ≥3 TEAEs (Part 2)

Primary Outcome 6 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 7 - Measure: Percentage of subjects with grade ≥3 TEAEs (Part 1)

Primary Outcome 7 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 8 - Measure: Percentage of subjects with grade ≥3 TEAEs (Part 2)

Primary Outcome 8 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 9 - Measure: Number of subjects with 1 or more SAEs (serious adverse events) (Part 1)

Primary Outcome 9 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 10 - Measure: Number of subjects with 1 or more SAEs (serious adverse events) (Part 2)

Primary Outcome 10 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 11 - Measure: Percentage of subjects with 1 or more SAEs (Part 1)

Primary Outcome 11 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 12 - Measure: Percentage of subjects with 1 or more SAEs (Part 2)

Primary Outcome 12 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 13 - Measure: Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1)

Primary Outcome 13 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 14 - Measure: Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2)

Primary Outcome 14 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 15 - Measure: Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)

Primary Outcome 15 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 16 - Measure: Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)

Primary Outcome 16 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 17 - Measure: Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1)

Primary Outcome 17 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 18 - Measure: Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2)

Primary Outcome 18 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 19 - Measure: Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)

Primary Outcome 19 - Timeframe: From the first dose until the last subject has completed their end of trial visit or the last enrolled subject has completed 6 months of treatment, whichever comes first

Primary Outcome 20 - Measure: Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)

Primary Outcome 20 - Timeframe: From the first dose until the last subject has 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 (Part 1):
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.
Inclusion Criteria (Part 2):
Subjects with histologically confirmed non-squamous metastatic (stage IV) NSCLC, without option for locoregional treatment with curative intent.

- Subjects who have not received prior systemic anti-cancer therapy for the locally advanced or metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.

- Ability to safety undergo pre-treatment (if no archival biopsy is available) and on-treatment tumor biopsies.

- Subject consents to retrieval of archival tumor tissue for screening in case no fresh biopsy is performed during screening.

- Willing and able to provide intravenous access for the administration of the study drug and for blood sampling/testing.
Exclusion Criteria (Parts 1 and 2):
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.
Exclusion criteria (Part 2):
Previous therapy with immunotherapy (anti-PD-1, anti-PD-L1, and anti-PD-L2, anti-CTLA-4, or other approved or investigational checkpoint-inhibitors).

- Subject is unable or unwilling to take folic acid or vitamin B12 supplementation.

- Subject is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDS), other than an aspirin dose ≤ 1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
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