Carcinoma, Non-Small-Cell LungPhase 1NCT04452214
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
A Phase 1 study testing CAN04, Pembrolizumab and Carboplatin in people with Carcinoma, Non-Small-Cell Lung and Urothelial Carcinoma, run by Cantargia AB at 3 sites in United States.
Trial 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 (NSCLC), head and neck squamous cell carcinoma, urothelial cancer, or malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Urothelial Carcinoma, Malignant Melanoma
- What is being tested?
- CAN04, Pembrolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Sep 2020to 28 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, 32746
Hospital of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104-5127
About this study
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
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Urothelial Carcinoma, Malignant Melanoma, Head and Neck Squamous Cell Carcinoma
- Being tested
- CAN04, Pembrolizumab, Carboplatin, Pemetrexed
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Transitional Cell, Melanoma, Squamous Cell Carcinoma of Head and Neck, Adenocarcinoma of Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN04Drug
Administered intravenously
PembrolizumabDrug
Administered intravenously
CarboplatinDrug
Administered intravenously
PemetrexedDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| CAN04 and pembrolizumab (Part 1) | Experimental | Subjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen Receives: Drug: CAN04; Drug: Pembrolizumab |
| CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) | Experimental | Subjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care Receives: Drug: CAN04; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of TEAEs (treatment-emergent adverse events) (Part 1)
Measured: 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
Frequency of TEAEs (treatment-emergent adverse events) (Part 2)
Measured: 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
Number of participants with DLTs (dose-limiting toxicities) (Part 1)
Measured: Up to day 28
Number of participants with DLTs (dose-limiting toxicities) (Part 2)
Measured: Up to day 28
Number of subjects with grade ≥3 TEAEs (Part 1)
Measured: 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
Number of subjects with grade ≥3 TEAEs (Part 2)
Measured: 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
Percentage of subjects with grade ≥3 TEAEs (Part 1)
Measured: 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
Percentage of subjects with grade ≥3 TEAEs (Part 2)
Measured: 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
Number of subjects with 1 or more SAEs (serious adverse events) (Part 1)
Measured: 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
Number of subjects with 1 or more SAEs (serious adverse events) (Part 2)
Measured: 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
Percentage of subjects with 1 or more SAEs (Part 1)
Measured: 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
Percentage of subjects with 1 or more SAEs (Part 2)
Measured: 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
Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
Measured: 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
Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
Measured: 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
Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
Measured: 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
Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
Measured: 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
Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
Measured: 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
Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
Measured: 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
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
Measured: 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
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
Measured: 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 outcomes (13)
Serum concentrations of CAN04 and pembrolizumab (Part 1)
Measured: 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
Serum concentrations of CAN04 and pembrolizumab (Part 2)
Measured: 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
Antidrug antibodies (ADAs) against CAN04
Measured: 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
Change in serum IL-6 (interleukin-6) concentration (Part 1)
Measured: 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
Change in serum IL-6 (interleukin-6) concentration (Part 2)
Measured: 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
Change in serum CRP (C-reactive protein) concentration (Part 1)
Measured: 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
Change in serum CRP (C-reactive protein) concentration (Part 2)
Measured: 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
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)
Measured: 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
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)
Measured: 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
Progression free survival (Part 1)
Measured: 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
Progression free survival (Part 2)
Measured: 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
Overall survival (Part 1)
Measured: Up to 36 months after 1st dose of last subject (or death)
Overall survival (Part 2)
Measured: Up to 36 months after 1st dose of last subject (or death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start24 Sep 2020
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantargia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignacio Garcia-Ribas, MD, PhD, Study director, Cantargia AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452214
- Sponsor's protocol ID
- CAN04CLIN002
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2020
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen RB, Jimeno A, Hreno J, Sun L, Wallen-Ohman M, Millrud CR, Sanfridson A, Garcia-Ribas I. Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors. Invest New Drugs. 2025 Jun;43(3):609-620. doi: 10.1007/s10637-025-01538-3. Epub 2025 May 1.
PubMed 40310569
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04452214
- Acronym / sponsor ID
- CAN04CLIN002
- Conditions
- Carcinoma, Non-Small-Cell Lung, Urothelial Carcinoma, Malignant Melanoma, Head and Neck Squamous Cell Carcinoma
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cantargia ABIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAN04 and pembrolizumab (Part 1) | Experimental | Drug: CAN04, Drug: PembrolizumabSubjects will receive weekly doses of CAN04 in combination with pembrolizumab given as standard regimen |
| CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) | Experimental | Drug: CAN04, Drug: Pembrolizumab, Drug: Carboplatin, Drug: PemetrexedSubjects will receive doses of CAN04 on Days 1 and 8 (Cycles 1 thru 4), and on Day 1 (Cycle 5 onwards) in combination with pembrolizumab given as standard regimen and carboplatin and pemetrexed standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Subjects with histologically confirmed non-squamous metastatic (stage IV) NSCLC, without option for locoregional treatment with curative intent.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAN04Administered intravenously | Drug | CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2), CAN04 and pembrolizumab (Part 1) |
| PembrolizumabAdministered intravenously | Drug | CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2), CAN04 and pembrolizumab (Part 1) |
| CarboplatinAdministered intravenously | Drug | CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) |
| PemetrexedAdministered intravenously | Drug | CAN04 + pembrolizumab + carboplatin + pemetrexed (Part 2) |
Primary outcome
Frequency of TEAEs (treatment-emergent adverse events) (Part 1)
Time frame: 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
Frequency of TEAEs (treatment-emergent adverse events) (Part 2)
Time frame: 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
Number of participants with DLTs (dose-limiting toxicities) (Part 1)
Time frame: Up to day 28
Number of participants with DLTs (dose-limiting toxicities) (Part 2)
Time frame: Up to day 28
Number of subjects with grade ≥3 TEAEs (Part 1)
Time frame: 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
Number of subjects with grade ≥3 TEAEs (Part 2)
Time frame: 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
Percentage of subjects with grade ≥3 TEAEs (Part 1)
Time frame: 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
Percentage of subjects with grade ≥3 TEAEs (Part 2)
Time frame: 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
Number of subjects with 1 or more SAEs (serious adverse events) (Part 1)
Time frame: 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
Number of subjects with 1 or more SAEs (serious adverse events) (Part 2)
Time frame: 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
Percentage of subjects with 1 or more SAEs (Part 1)
Time frame: 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
Percentage of subjects with 1 or more SAEs (Part 2)
Time frame: 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
Number of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
Time frame: 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
Number of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
Time frame: 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
Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
Time frame: 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
Number of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
Time frame: 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
Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 1)
Time frame: 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
Percentage of subjects with 1 or more TEAEs leading to dose modifications (Part 2)
Time frame: 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
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 1)
Time frame: 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
Percentage of subjects with 1 or more TEAEs leading to treatment discontinuation (Part 2)
Time frame: 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
13 secondary outcomes
Serum concentrations of CAN04 and pembrolizumab (Part 1)
Time frame: 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
Serum concentrations of CAN04 and pembrolizumab (Part 2)
Time frame: 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
Antidrug antibodies (ADAs) against CAN04
Time frame: 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
Change in serum IL-6 (interleukin-6) concentration (Part 1)
Time frame: 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
Change in serum IL-6 (interleukin-6) concentration (Part 2)
Time frame: 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
Change in serum CRP (C-reactive protein) concentration (Part 1)
Time frame: 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
Change in serum CRP (C-reactive protein) concentration (Part 2)
Time frame: 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
Overall response rate (ORR) (Part 1)
Time frame: 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
Overall response rate (ORR) (Part 2)
Time frame: 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
Progression free survival (Part 1)
Time frame: 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
Progression free survival (Part 2)
Time frame: 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
Overall survival (Part 1)
Time frame: Up to 36 months after 1st dose of last subject (or death)
Overall survival (Part 2)
Time frame: Up to 36 months after 1st dose of last subject (or death)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Derived from this study: PubMed 40310569Cohen RB, Jimeno A, Hreno J, Sun L, Wallen-Ohman M, Millrud CR, Sanfridson A, Garcia-Ribas I. Safety, tolerability, and preliminary efficacy of nadunolimab, an anti-IL- 1 receptor accessory protein monoclonal antibody, in combination with pembrolizumab in patients with solid tumors. Invest New Drugs. 2025 Jun;43(3):609-620. doi: 10.1007/s10637-025-01538-3. Epub 2025 May 1.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- FDA Recalls, Market Withdrawals, and Safety AlertsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Garcia-Ribas, MD, PhD study director
Cantargia AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAN04, Pembrolizumab and Carboplatin in people with Carcinoma, Non-Small-Cell Lung and Urothelial Carcinoma, run by Cantargia AB at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of TEAEs (treatment-emergent adverse events) (Part 1) (time frame: 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). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.