A Phase 1/2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours
Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.
⁃ Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study
⁃ Adult males and females ≥18 years of age at screening
⁃ Life expectancy of at least 3 months
⁃ Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)
⁃ Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular/biomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate
⁃ Eligible tumor types include:
⁃ Head and neck squamous cell carcinoma
⁃ Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)
⁃ Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)
⁃ Genitourinary malignancies (bladder, renal cell, prostate cancer)
⁃ Gynecologic malignancies (ovarian, endometrial cancer)
⁃ Breast cancer and melanoma
⁃ Evaluable disease per RECIST v1.1
⁃ ECOG performance status 0-1 (or up to 2 at PI discretion)
⁃ Adequate organ function, defined as:
⁃ Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)
⁃ AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)
⁃ Creatinine clearance ≥50 mL/min (Cockcroft-Gault) or eGFR ≥50 mL/min (CKD-EPI)
⁃ Absolute neutrophil count ≥1,000/mm³
⁃ Platelet count ≥100,000/mm³
⁃ Hemoglobin ≥90 g/L without transfusion within 2 weeks
⁃ Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)
‣ Female patients:
• Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose
‣ Male patients:
⁃ Agreement not to donate sperm for 90 days post-dose
⁃ Agreement to use adequate contraception as applicable
⁃ Suitable venous access for blood sampling
⁃ Willingness and ability to comply with study procedures and protocol requirements