A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumor, NSCLC

In brief

CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.

Key facts

Study ID

NCT05117476

Run by

Cullinan Therapeutics Inc.

People needed

440

Starts

2021-10-29

Expected to finish

2026-06-01

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged ≥ 18 years.
• Willing and able to give written informed consent and adhere to protocol requirements; written informed consent and any locally required authorization must be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
• Module A Monotherapy Dose Escalation Cohort and Module B Combination Therapy Dose Escalation Cohorts: Histologically or cytologically-confirmed metastatic or locally advanced, unresectable solid tumors. For Module B, tumor type is listed as an approved indication per the current prescribing information for pembrolizumab.
• Module A Cohort Expansions:
• Expansion A1: Histologically or cytologically-confirmed metastatic or locally advanced, unresectable NSCLC;
• Expansion A2: Histologically or cytologically-confirmed metastatic or locally advanced, unresectable cervical cancer.
• Expansion A3 and A4: Histologically or cytologically-confirmed metastatic or locally advanced, unresectable endometrial cancer.
• Eligibility for disease-specific expansion cohorts may be further refined by histologic subtype, molecular features, or exposure to prior therapy based on clinical, pharmacodynamic, or biomarker data emerging from the study.
• Module B Cohort Expansions:
• Expansion B1: Histologically or cytologically-confirmed metastatic or locally-advanced, unresectable NSCLC.
• Expansion B2: Histologically or cytologically-confirmed metastatic or locally-advanced, unresectable endometrial.
• Eligibility for disease-specific expansion cohorts may be further refined by histologic subtype, molecular features, or exposure to prior therapy based on clinical, pharmacodynamic, or biomarker data emerging from the study.
• Module C CLN-619 + Chemotherapy Combination Therapy, Escalation and Expansion Cohort
• C1: Histologically or cytologically confirmed metastatic or locally advanced, unresectable EGFRm NSCLC.
• C2: Histologically or cytologically confirmed metastatic or locally advanced, unresectable endometrial cancer.
• C3: Histologically or cytologically confirmed metastatic or locally advanced, unresectable, platinum-resistant epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer).
• Eligibility for disease-specific expansion cohorts may be further refined by histologic subtype, molecular features, or exposure to prior therapy based on clinical, pharmacodynamic, or biomarker data emerging from the study.
• Module D Loading Dose Cohort:
• a) Tumor types are restricted to epithelial ovarian (including fallopian tube and primary peritoneal), breast, and gastrointestinal (esophageal, gastric, colorectal).
• Module E CLN-619 + Dato-DXd Combination Therapy, Safety Run-in and Expansion Cohorts:
• Histologically or cytologically confirmed recurrent metastatic or locally advanced, unresectable EGFRm NSCLC.
• Local testing for determination of the mutation status is required.
• Prior treatment history as follows:
• Patients should have received any other approved standard therapy that is available to the patient, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.
• Patients eligible for Module E must meet the following criteria: Have received up to 4 prior lines of therapy, including i. Platinum-based chemotherapy ii. At least 1 EGFRm-directed targeted therapy iii. If EGFR T790M, must have received prior osimertinib iv. Prior treatment with topoisomerase I-targeted chemotherapeutic agent or TROP2-directed therapy not allowed

You may not qualify if…

• Currently participating/previously participated in an interventional study and received an investigational drug within 28 days (or five half-lives, whichever is longer) of dosing on C1D1.
• 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 three 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 or suspected 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 assessment;
• Uncontrolled, clinically significant pulmonary disease;
• Requirement for supplemental oxygen to maintain a pulse ox > 93%;
• Symptomatic congestive heart failure as per Investigator assessment or documented cardiac ejection fraction less than 45%;
• Ejection fraction < 45% in patients with prior history of treatment with anthracycline chemotherapy or with a prior history of cardiac ventricular dysfunction;
• History of unstable angina or myocardial infarction within six months of dosing on C1D1;
• Unstable cardiac arrhythmia;
• History of ventricular arrhythmia;
• Uncontrolled hypertension: patients with sustained systolic blood pressure readings greater than 150 or diastolic blood pressure greater than 100 should have documentation by 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;
• Recent major surgery within three months of dosing on C1D1 or major surgery with unresolved complications that could interfere with study treatment.
• Clinically significant corneal disease (Module E).
• Treatment with systemic antiviral, antibacterial or antifungal agents for acute infection within ≤ 7 days of dosing on C1D1.
• Has known human immunodeficiency virus (HIV) infection that is not well controlled.
• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope — Duarte, California, United States
• City of Hope — Irvine, California, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• START Midwest — Grand Rapids, Michigan, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Carolina BioOncology Institute — Huntersville, North Carolina, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• START San Antonio — San Antonio, Texas, United States
• Virginia Cancer Center — Fairfax, Virginia, United States
• Monash Health — Clayton, Victoria, Australia
• Alfred Health — Melbourne, Victoria, Australia
• Linear Clinical Research — Nedlands, Western Australia, Australia
• Biokinetica — Józefów, Poland
• Med-Polonia Sp. zo. o. — Poznan, Poland
• Narodowy Insytut Onkologii im Marii Sklodowskiej-Curie — Warsaw, Poland
• Hospital Universitario Insular de Gran Canaria — Las Palmas de Gran Canaria, Gran Canaria, Spain
• START Barcelona — Barcelona, Spain
• Hospital Clinic Barcelona — Barcelona, Spain
• START Madrid FJD — Madrid, Spain
• Clinica Universidad de Navarra — Pamplona, Spain
• Hospital Universitari Parc Tauli — Sabadell, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.