Description:
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.
Title
- Brief Title: A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CAN04CLIN002
- NCT ID:
NCT04452214
Conditions
- Carcinoma, Non-Small-Cell Lung
- Urothelial Carcinoma
- Malignant Melanoma
- Head and Neck Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
CAN04 | | CAN04 and pembrolizumab |
Pembrolizumab | | CAN04 and pembrolizumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CAN04 and pembrolizumab | Experimental | Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Frequency of TEAEs (treatment-emergent adverse events) |
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 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Serum concentrations of CAN04 and pembrolizumab |
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 |
Safety Issue: | |
Description: | |
Measure: | Antidrug antibodies (ADAs) against CAN04 |
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 |
Safety Issue: | |
Description: | |
Measure: | Change in serum IL-6 (interleukin-6) concentration |
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 |
Safety Issue: | |
Description: | |
Measure: | Change in serum CRP (C-reactive protein) concentration |
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 |
Safety Issue: | |
Description: | |
Measure: | Overall response rate (ORR) |
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 |
Safety Issue: | |
Description: | Proportion of subjects with partial response (PR) or complete response (CR) to study treatment as defined by iRECIST (immune-related response evaluation criteria in solid tumors) and measured by radiological assessment (CT/MRI scan) |
Measure: | Progression free survival |
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 |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Up to 36 months after 1st dose of last subject (or death) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Cantargia AB |
Trial Keywords
- NSCLC
- Adenocarcinoma of lung
- Lung cancer
- Squamous cell lung cancer
- Malignant melanoma
- Urothelial cancer
- Non-small-cell lung cancer
- Non small cell lung cancer
- Non-small-cell lung carcinoma
- Non small cell lung carcinoma
- HNSCC
- Head and neck squamous cell carcinoma
Last Updated
November 18, 2020