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 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
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
Name: Ignacio Garcia-Ribas, MD, PhD
Role: Study Director
Affiliation: Chief Medical Officer, Cantargia AB
Name: Ignacio Garcia-Ribas, MD, PhD
Phone: +34 649 450384
Email: ignacio.garcia-ribas@cantargia.com
Link: FDA Safety Alerts and Recalls
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 |