A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors

P-MUC1C-ALLO1-001

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.

2022-02-15

2026-04-01

2039-04-01

Recruiting

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at recommended phase 2 dose (RP2D)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-04-23