Breast Cancer Clinical Trial
Official title:
A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 2039 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Males or females, Subjects =18 years with life expectancy >3 months - Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer, refractory to standard of care therapy or ineligible or refused other existing treatment options - Must have progressed during or after last therapy and have measurable disease - Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status =70% - Must have adequate vital organ function within pre-determined parameters - Must have archived tumor tissue available or consent to a biopsy collection - Must be willing to practice birth control - Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration - Must have recovered from toxicities due to prior therapies Exclusion Criteria: - Has inadequate venous access - Has an active second malignancy in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma - Is pregnant or lactating - Has a history of or active autoimmune disease - Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy - Has an active systemic (viral, bacterial, or fungal) infection - Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia - Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol - Has received anticancer medications within 2 weeks of the time of initiating conditioning chemotherapy - Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study - Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study - Has known CNS metastases or symptomatic CNS involvement - Has a history of significant liver disease or active liver disease - Has a history of known genetic predisposition to HLH/MAS |
Country | Name | City | State |
---|---|---|---|
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Sarah Cannon Research Institute at HealthONE | Denver | Colorado |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | NEXT Oncology | San Antonio | Texas |
United States | University of California, San Diego | San Diego | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Kansas Cancer Center | Westwood | Kansas |
United States | Cancer Center of Kansas | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Poseida Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 | Number of subjects with a dose limiting toxicity (DLT) | Baseline through Day 28 | |
Primary | Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1 | Frequency and severity of adverse events | Baseline through 15 years | |
Primary | Evaluate the preliminary efficacy of P-MUC1C-ALLO1 | According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR) | Baseline through 15 years |
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