A Study of the Safety and Tolerance of CAN04 in Combination With Pembrolizumab in Subjects With Solid Tumors
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ClinicalTrials.gov Identifier: NCT04452214 |
Recruitment Status :
Recruiting
First Posted : June 30, 2020
Last Update Posted : November 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung Urothelial Carcinoma Malignant Melanoma Head and Neck Squamous Cell Carcinoma | Drug: CAN04 Drug: Pembrolizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 24, 2020 |
Estimated Primary Completion Date : | January 2022 |
Estimated Study Completion Date : | January 2022 |

Arm | Intervention/treatment |
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Experimental: CAN04 and pembrolizumab
Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen
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Drug: CAN04
Administered intravenously Drug: Pembrolizumab Administered intravenously |
- 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 ]
- Number of participants with DLTs (dose-limiting toxicities) [ Time Frame: Up to day 28 ]
- Number of subjects with grade ≥3 TEAEs [ 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 ]
- Percentage of subjects with grade ≥3 TEAEs [ 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 ]
- Number of subjects with 1 or more SAEs (serious 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 ]
- Percentage of subjects with 1 or more SAEs [ 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 ]
- Number of subjects with 1 or more TEAEs leading to dose modifications [ 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 ]
- Number of subjects with 1 or more TEAEs leading to treatment discontinuation [ 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 ]
- Percentage of subjects with 1 or more TEAEs leading to dose modifications [ 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 ]
- Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation [ 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]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)
- 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 ]
- Overall survival [ Time Frame: Up to 36 months after 1st dose of last subject (or death) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452214
Contact: Ignacio Garcia-Ribas, MD, PhD | +34 649 450384 | ignacio.garcia-ribas@cantargia.com | |
Contact: Marie Wallén Öhman | marie.wallen-ohman@cantargia.com |
United States, Colorado | |
University of Colorado Cancer Center | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Site Manager 720-848-0676 paula.fisk@cuanschutz.edu | |
United States, Florida | |
Florida Cancer Specialists & Research Institute | Recruiting |
Lake Mary, Florida, United States, 32746 | |
Contact: Study Coordinator 407-804-6133 ajackson@flcancer.com | |
United States, Pennsylvania | |
Hospital of The University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-5127 | |
Contact: Site Manager 215-220-9703 Melissa.Volpe@pennmedicine.upenn.edu |
Study Director: | Ignacio Garcia-Ribas, MD, PhD | Chief Medical Officer, Cantargia AB |
Responsible Party: | Cantargia AB |
ClinicalTrials.gov Identifier: | NCT04452214 |
Other Study ID Numbers: |
CAN04CLIN002 |
First Posted: | June 30, 2020 Key Record Dates |
Last Update Posted: | November 18, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Carcinoma Melanoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas |
Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents |