Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
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
Verified date | July 2023 |
Source | Cantargia AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | June 28, 2023 |
Est. primary completion date | June 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Cancer Center | Aurora | Colorado |
United States | Florida Cancer Specialists & Research Institute | Lake Mary | Florida |
United States | Hospital of The University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Cantargia AB |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of TEAEs (treatment-emergent adverse events) (Part 1) | 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 | Frequency of TEAEs (treatment-emergent adverse events) (Part 2) | 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 | Number of participants with DLTs (dose-limiting toxicities) (Part 1) | Up to day 28 | ||
Primary | Number of participants with DLTs (dose-limiting toxicities) (Part 2) | Up to day 28 | ||
Primary | Number of subjects with grade =3 TEAEs (Part 1) | 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 | Number of subjects with grade =3 TEAEs (Part 2) | 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 | Percentage of subjects with grade =3 TEAEs (Part 1) | 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 | Percentage of subjects with grade =3 TEAEs (Part 2) | 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 | Number of subjects with 1 or more SAEs (serious adverse events) (Part 1) | 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 | Number of subjects with 1 or more SAEs (serious adverse events) (Part 2) | 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 | Percentage of subjects with 1 or more SAEs (Part 1) | 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 | Percentage of subjects with 1 or more SAEs (Part 2) | 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 | Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1) | 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 | Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2) | 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 | Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1) | 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 | Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2) | 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 | Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1) | 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 | Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2) | 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 | Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1) | 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 | Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2) | 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 | ||
Secondary | Serum concentrations of CAN04 and pembrolizumab (Part 1) | 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 | ||
Secondary | Serum concentrations of CAN04 and pembrolizumab (Part 2) | 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 | ||
Secondary | Antidrug antibodies (ADAs) against CAN04 | 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 | ||
Secondary | Change in serum IL-6 (interleukin-6) concentration (Part 1) | 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 | ||
Secondary | Change in serum IL-6 (interleukin-6) concentration (Part 2) | 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 | ||
Secondary | Change in serum CRP (C-reactive protein) concentration (Part 1) | 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 | ||
Secondary | Change in serum CRP (C-reactive protein) concentration (Part 2) | 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 | ||
Secondary | Overall response rate (ORR) (Part 1) | 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) | 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 | |
Secondary | Overall response rate (ORR) (Part 2) | 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) | 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 | |
Secondary | Progression free survival (Part 1) | 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 | ||
Secondary | Progression free survival (Part 2) | 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 | ||
Secondary | Overall survival (Part 1) | Up to 36 months after 1st dose of last subject (or death) | ||
Secondary | Overall survival (Part 2) | Up to 36 months after 1st dose of last subject (or death) |
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