Advanced Solid TumorPhase 1NCT06035744
CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
A Phase 1 study testing CLN-617 and Pembrolizumab in people with Advanced Solid Tumor, run by Cullinan Therapeutics Inc. at 5 sites in United States.
Trial summary
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CLN-617 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Dec 2023to 16 Jun 2026
- 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
- Aged ≥ 18 years.
- Patient should have previously received or had a contraindication to standard therapy that confers an overall survival benefit.
- Part 1 Dose Escalation Cohorts: Histologically or cytologically confirmed advanced incurable or metastatic non-neurological solid tumor with accessible injectable lesions.
- Part 2 Dose Optimization: Histologically or cytologically confirmed select advanced incurable or metastatic cancer types with accessible injectable lesions.
- Part 3 Dose Expansions:
- Cohort 1: Histologically or cytologically confirmed metastatic or locally advanced, unresectable melanoma with accessible injectable lesions.
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- Cohort 2: Histologically or cytologically confirmed metastatic or locally advanced, unresectable HNSCC with accessible injectable lesions.
- Patients must have 2 or more measurable lesions for Part 1, or one or more measurable lesions for Part 2 and Part 3 that meet RECIST v1.1. Also, patients must have tumors able to be palpable, visualized on ultrasound without encasing with blood vessels, amenable to direct injection.
- Patients deemed appropriate for pembrolizumab treatment based on the tumor type and prior available therapy, per the judgment of the investigator.
- Performance status of 0 or 1 based on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- Estimated life expectancy at least 12 weeks or longer.
- Toxicities related to prior study therapy should have resolved to Grade 1 or less according to criteria of NCI CTCAE v5.0, except for alopecia. Patients with chronic but stable Grade 2 toxicities may be allowed to enroll after an agreement between the Investigator and Sponsor.
- Have adequate liver and kidney function and hematological parameters within a normal range as defined by:
- Total bilirubin ≤ 1.5x ULN. This does not apply for patients with confirmed Gilbert's Syndrome, for whom total bilirubin must be less than 3.0 mg/dL with a conjugated bilirubin less than 0.5 mg/dL.
- AST and ALT ≤ 2.5x ULN or ≤ 5x ULN for patients with liver metastases.
- Estimated creatinine clearance (CrCL) ≥ 50 mL/min by using Cockcroft-Gault formula.
- Hemoglobin ≥ 8 g/dL without blood transfusions for at least two weeks prior to dosing on C1D1.
- Absolute neutrophil count ≥ 1500 cells/mm3 without growth factor support (e.g., three days for filgrastim, 14 days for pegfilgrastim).
- Platelet count ≥ 100,000 cells/mm3.
- Patients in dose escalation (Part 1) must agree to provide a fresh biopsy at baseline, and on-treatment biopsies from both injected and uninjected tumors, at the end of Cycle 1 (mandatory) and at the end of Cycle 3 (strongly encouraged). Patients in dose optimization (Part 2) and dose-expansion (Part 3) must agree to provide a fresh biopsy at baseline, and an on-treatment biopsy from both injected and uninjected tumors at the end of Cycle 2. If a biopsy cannot be performed with acceptable clinical risk in the judgment of the Investigator, the Sponsor's medical monitor must be contacted to approve enrollment.
Who cannot join
- Patients with concomitant second malignancies (except adequately treated non-melanomatous skin cancers, ductal carcinoma in situ, superficial bladder cancer, prostate cancer, or in situ cervical cancer) are excluded unless in complete remission two years prior to study entry, and no additional therapy is required or anticipated to be required during study participation.
- Patients with any active autoimmune disease or a history of known autoimmune disease, or history of a syndrome that requires systemic corticosteroids or immunosuppressive medications, except for patients with vitiligo, resolved childhood asthma/atopy, or autoimmune thyroid disorders on stable thyroid hormone supplementation.
- A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy. These criteria include, but are not limited to the following:
- Uncontrolled airway hyper-reactivity.
- Type 1 diabetes mellitus. Type 2 diabetes mellitus patients are allowed if they are under stable glycemic control as per Investigator's assessment.
- Uncontrolled, clinically significant pulmonary disease.
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- Requirement for supplemental oxygen to maintain SpO2 > 93%.
- Symptomatic congestive heart failure as per Investigator's assessment or documented cardiac ejection fraction < 45%.
- QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≥ 470 milliseconds.
- History of unstable angina or myocardial infarction within six months of dosing on C1D1.
- Unstable cardiac arrhythmia.
- History of ventricular arrhythmia that requires medical treatment.
- Uncontrolled hypertension: patients with sustained systolic blood pressure readings greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg should have documentation by the treating physician that the finding is not consistent with uncontrolled hypertension.
- History of stroke or cerebral hemorrhage within one year of dosing on C1D1.
- Poorly controlled seizure disorder.
- Active diverticulitis within one year prior to dosing on C1D1.
- Patient requires active systemic anticoagulation at the time of IT injection or biopsy, or with significant bleeding diathesis due to risk of hematoma at the injection site. Patients on anticoagulant agents require consultation with the sponsor prior to enrollment.
- Risk of vascular catastrophe.
- Treatment with systemic antiviral, antibacterial or antifungal agents for acute infection within ≤ 7 days of dosing on C1D1.
- Diagnosed with HIV1/2 primary immunodeficiency disease with any of the following conditions:
- CD4+ T cell counts ≤ 350 cells/uL.
- Received active antiretroviral therapy within 4 weeks of C1D1.
- HIV viral load > 400 copies/mL.
- Diagnosed with hepatitis B (with positive testing for either hepatitis B surface antigen [HbsAg] or hepatitis B core Ab) or hepatitis C virus (HCV) infection (with positive testing for HCV antibody and/or HCV ribonucleic acid [RNA] in serum) under any of the following conditions:
- Active disease for hepatitis B or hepatitis C and received antiretroviral therapy within 4 weeks.
- Blood hepatitis B DNA or HCV RNA are detectable.
- Prior organ allograft or allogeneic hematopoietic transplantation.
- Active central nervous system metastases and/or carcinomatous meningitis. Patients with brain metastases identified at Screening may be rescreened after they have been appropriately treated. Patients with treated brain metastases should be neurologically stable for 28 days post completion of treatment and prior to enrollment and on a stable regimen of steroid dosing (prednisone < 10 mg daily or the equivalent) for 14 days prior to dosing on C1D1.
- Active SARS-CoV-2 infection, including the history of positive SARS-CoV-2 testing without subsequent documentation of negative test results, patients with results that are pending but not yet known, or patients with suspected active infection based on clinical features.
- Has received immunosuppressive medications including but not limited to CellCept, methotrexate, infliximab, anakinra, tocilizumab, cyclosporine, or corticosteroids (≥10 mg/day of prednisone or equivalent), within 28 days of dosing on C1D1.
- Treatment with any of the following:
- Systemic anticancer treatment within 14 days prior to the first dose of the study drug on C1D1.
- Immunotherapy ≤ 28 days prior to the first dose of study drug on C1D1.
- Radiotherapy < 28 days and palliative radiation ≤ 14 days prior to the first dose of study the drug on C1D1.
- Major surgery (excluding placement of vascular access) ≤ 28 days of the first dose of study drug on C1D1.
- Female of child-bearing potential (FOCBP) who is pregnant or breast-feeding, plans to become pregnant within 120 days of last study drug administration or declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days after the last dose of study drug administration.
- Note: Females with amenorrhea for < 2 years and who are not surgically sterile i.e., tubal ligation, bilateral oophorectomy, or complete hysterectomy, will only be considered not to be of reproductive potential if they have a documented follicle stimulating hormone (FSH) value in the postmenopausal range.
- Male patient who plans to father a child or donate sperm within 120 days or 5 half-lives of CLN-617 whichever comes later, of last study drug administration, or who has a partner who is a FOCBP, and declines to use an acceptable method to prevent pregnancy during study treatment and for 120 days or 5 half-lives of CLN-617, whichever comes later, after the last dose of study drug administration.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Chicago
Chicago, Illinois, 60637
MD Anderson
Houston, Texas, 77030
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Orlando Health
Orlando, Florida, 32806
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
Official title: A Phase 1 First-in-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors
- Conditions
- Advanced Solid Tumor
- Being tested
- CLN-617, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-617Drug
Single-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences
PembrolizumabDrug
Also called Keytruda
Humanized IgG4 anti-PD-1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| CLN-617 Dose Escalation (Part A) | Experimental | Patients with Advanced Solid Tumors enrolled in dose escalation cohorts treated with CLN-617 alone and in combination with pembrolizumab Receives: Drug: CLN-617; Drug: Pembrolizumab |
| CLN-617 Dose Optimization (Part B) | Experimental | Patients with Advanced Solid Tumors enrolled in dose optimization receiving selected doses of CLN-617 in combination with pembrolizumab Receives: Drug: CLN-617; Drug: Pembrolizumab |
| CLN-617 Dose Expansion (Part C) | Experimental | Patients with Advanced Melanoma or Head and Neck Squamous Cell Carcinoma (HNSCC) enrolled in dose expansion treated with CLN-617 in combination with pembrolizumab Receives: Drug: CLN-617; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation
Number of treatment-emergent events (TEAEs): TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Measured: 24 Months
Dose Optimization
Number of treatment-emergent events (TEAEs): TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Measured: 24 Months
Dose Expansion
Overall Response Rate (ORR): The % of patients having a CR or PR as determined by PI assessment of disease response per iRECIST
Measured: 24 Months
Dose Expansion
Duration of Response (DoR): The time from the earliest date of CR or PR until the earliest date of disease progression, as determined by PI assessment of disease response per iRECIST or death from any cause if occurring sooner than progression
Measured: 24 Months
Dose Expansion
Disease Control Rate (DCR): The % of participants having CR, PR, or SD as best on study response
Measured: 24 Months
Dose Expansion
Progression Free Survival (PFS): Time from initiate date of treatment to disease progression or death
Measured: 24 Months
Dose Expansion
Overall Survival (OS): Time from the initial date of treatment until death
Measured: 24 Months
Secondary outcomes (6)
All Cohorts
Maximum drug concentration (Cmax) of CLN-617
Measured: 24 Months
All Cohorts
Area under the curve up to tau (AUCtau) of CLN-617
Measured: 24 Months
All Cohorts
Time to Cmax (Tmax) of CLN-617
Measured: 24 Months
All Cohorts
Last validated plasma concentration (Clast) of CLN-617
Measured: 24 Months
All Cohorts
Time to Clast (Tlast) of CLN-617
Measured: 24 Months
All Cohorts
Terminal Half-life (t1/2) of CLN-617
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start12 Dec 2023
- Primary completion16 Jun 2026
- Study completion16 Jun 2026
Why it stopped: Company decision
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 Advanced Solid TumorStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035744
- Sponsor's protocol ID
- CLN-617-001
- Status last verified
- Jun 2026
- First submitted
- 31 Aug 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta NK, Rakhra K, Meetze KA, Li B, Momin N, Chang JYH, Wittrup KD, Baeuerle PA, Michaelson JS. CLN-617 Retains IL2 and IL12 in Injected Tumors to Drive Robust and Systemic Immune-Mediated Antitumor Activity. Cancer Immunol Res. 2024 Aug 1;12(8):1022-1038. doi: 10.1158/2326-6066.CIR-23-0636.
PubMed 38842347
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06035744
- Acronym / sponsor ID
- CLN-617-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Cullinan Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 13 Sep 2023 (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.
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CLN-617 Dose Escalation (Part A) | Experimental | Drug: CLN-617, Drug: PembrolizumabPatients with Advanced Solid Tumors enrolled in dose escalation cohorts treated with CLN-617 alone and in combination with pembrolizumab |
| CLN-617 Dose Optimization (Part B) | Experimental | Drug: CLN-617, Drug: PembrolizumabPatients with Advanced Solid Tumors enrolled in dose optimization receiving selected doses of CLN-617 in combination with pembrolizumab |
| CLN-617 Dose Expansion (Part C) | Experimental | Drug: CLN-617, Drug: PembrolizumabPatients with Advanced Melanoma or Head and Neck Squamous Cell Carcinoma (HNSCC) enrolled in dose expansion treated with CLN-617 in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Aged ≥ 18 years.
- Patient should have previously received or had a contraindication to standard therapy that confers an overall survival benefit.
- Part 1 Dose Escalation Cohorts: Histologically or cytologically confirmed advanced incurable or metastatic non-neurological solid tumor with accessible injectable lesions.
- Part 2 Dose Optimization: Histologically or cytologically confirmed select advanced incurable or metastatic cancer types with accessible injectable lesions.
- Part 3 Dose Expansions:
Key exclusion criteria (38 listed)
- Patients with concomitant second malignancies (except adequately treated non-melanomatous skin cancers, ductal carcinoma in situ, superficial bladder cancer, prostate cancer, or in situ cervical cancer) are excluded unless in complete remission two years prior to study entry, and no additional therapy is required or anticipated to be required during study participation.
- Patients with any active autoimmune disease or a history of known autoimmune disease, or history of a syndrome that requires systemic corticosteroids or immunosuppressive medications, except for patients with vitiligo, resolved childhood asthma/atopy, or autoimmune thyroid disorders on stable thyroid hormone supplementation.
- A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy or whose control may be jeopardized by the complications of this therapy. These criteria include, but are not limited to the following:
- Patient requires active systemic anticoagulation at the time of IT injection or biopsy, or with significant bleeding diathesis due to risk of hematoma at the injection site. Patients on anticoagulant agents require consultation with the sponsor prior to enrollment.
- Risk of vascular catastrophe.
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 |
|---|---|---|
| CLN-617Single-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences | Drug | CLN-617 Dose Escalation (Part A), CLN-617 Dose Expansion (Part C), CLN-617 Dose Optimization (Part B) |
| PembrolizumabAlso: KeytrudaHumanized IgG4 anti-PD-1 monoclonal antibody | Drug | CLN-617 Dose Escalation (Part A), CLN-617 Dose Expansion (Part C), CLN-617 Dose Optimization (Part B) |
Primary outcome
Dose Escalation
Time frame: 24 Months
Number of treatment-emergent events (TEAEs): TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Dose Optimization
Time frame: 24 Months
Number of treatment-emergent events (TEAEs): TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Dose Expansion
Time frame: 24 Months
Overall Response Rate (ORR): The % of patients having a CR or PR as determined by PI assessment of disease response per iRECIST
Dose Expansion
Time frame: 24 Months
Duration of Response (DoR): The time from the earliest date of CR or PR until the earliest date of disease progression, as determined by PI assessment of disease response per iRECIST or death from any cause if occurring sooner than progression
Dose Expansion
Time frame: 24 Months
Disease Control Rate (DCR): The % of participants having CR, PR, or SD as best on study response
Dose Expansion
Time frame: 24 Months
Progression Free Survival (PFS): Time from initiate date of treatment to disease progression or death
Dose Expansion
Time frame: 24 Months
Overall Survival (OS): Time from the initial date of treatment until death
6 secondary outcomes
All Cohorts
Time frame: 24 Months
All Cohorts
Time frame: 24 Months
All Cohorts
Time frame: 24 Months
All Cohorts
Time frame: 24 Months
All Cohorts
Time frame: 24 Months
All Cohorts
Time frame: 24 Months
Results and safety
The study was stopped early (reason given: Company decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Derived from this study: PubMed 38842347Mehta NK, Rakhra K, Meetze KA, Li B, Momin N, Chang JYH, Wittrup KD, Baeuerle PA, Michaelson JS. CLN-617 Retains IL2 and IL12 in Injected Tumors to Drive Robust and Systemic Immune-Mediated Antitumor Activity. Cancer Immunol Res. 2024 Aug 1;12(8):1022-1038. doi: 10.1158/2326-6066.CIR-23-0636.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 CLN-617 and Pembrolizumab in people with Advanced Solid Tumor, run by Cullinan Therapeutics Inc. at 5 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 20 inclusion and 38 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: stopped early, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early (reason given: Company decision). Results are not available in the source record.
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?
Dose Escalation (time frame: 24 Months). The study lists 7 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 NCT06035744, 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 18 Jun 2026.