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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantargia AB
• Treatments: Pembrolizumab

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.