Safety and Efficacy of SL-28 in Patients With Advanced Solid Tumours ( Phase 1/2)
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 Pty Ltd
12 participants
Dec 22, 2025
Interventional
Conditions
Summary
This study aims to assess the anti-tumour activity, safety, and interactions of single-agent SL-28 as an anti-cancer treatment in patients with a diverse array of solid tumours. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced solid tumor, including head and neck cancer, small-cell lung cancer, non-small cell lung cancer; mesothelioma; oesophageal cancer, gastric cancer, liver cancer, colorectal cancer, pancreatic cancer, bladder cancer, kidney cancer, prostate cancer, ovarian cancer, endometrial cancer, breast cancer or skin cancer (melanoma) that is locally advanced, metastatic or unable to be surgically removed. Patients will also be assessed by a study doctor to ensure that they are well enough to participate in the trial before they will be offered enrolment into the study. Study details All participants who choose to enroll in this study will receive 12 weeks of SL-28 treatment, administered on a 5-days-on, 2-days-off schedule. The first group of participants to receive SL-28 will be monitored for 12 weeks before a second group may be administered a higher dose of SL-28. Up to three cohorts will be enrolled to determine the highest safe and effective dose that does not cause severe side effects in patients. It is hoped this study will show that SL-28 is safe to deliver to patients with solid tumour cancers, and determine the highest dose of SL-28 that cancer patients can safely receive.
Eligibility
Inclusion Criteria2
- Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females, 18 years of age at screening.3. Life expectancy of at least 3 months.4. Histologically or cytologically confirmed unresectable advanced solid tumour (i.e., recurrent, metastatic, or locally advanced disease). Patients must be considered, in the opinion of the PI (or delegate), refractory or intolerant to standard therapies, including all immunotherapy and molecular and biomarker directed treatments for advanced or metastatic disease, or have refused standard therapy. The following tumour types are to be considered:a. Head and Neck: Head and neck squamous cell carcinomab. Thoracic: Small-cell lung cancer; Non-small cell lung cancer; oesophageal cancerc. Gastrointestinal: Gastric cancer; liver cancer; colorectal cancer; pancreatic adenocarcinomad. Genitourinary: Bladder cancer; renal cell carcinoma; prostate cancere. Gynaecologic: Ovarian cancer; endometrial cancerf. Breast and Skin: Breast cancer; melanoma. 5. Evaluable disease per RECIST 1.1.6. Eastern Cooperative Oncology Group performance score of 0 to 1, or up to 2 at the discretion of the PI.7. Adequate organ function defined as:a. Total bilirubin equal to 1.5 times upper limit of normal (ULN) (less than 2.0×ULN for patients with liver metastases or documented Gilbert’s syndrome)b. AST (SGOT), ALT (SGPT) and alkaline phosphatase equal to 2.5 times ULN (if liver metastases are present, then equal to 5×ULN is acceptable at PI discretion)c. Calculated creatinine clearance equal to 50 mL/min calculated by Cockcroft-Gaultd. Serum creatinine less than 1.5 ULN or an estimated glomerular filtration rate equal to50 mL/min using the Chronic Kidney Disease Epidemiology Collaboration formulae. Absolute neutrophil count equal to 1500/mm3 f. Neutrophil count equal to1000/mm³ g. Platelet count equal to 100,000/mm³ h. Haemoglobin equal to 90.0 g/L (in the absence of a packed red blood cell transfusion within last 2 weeks)i. Prothrombin time equal to 1.5× the ULN and activated partial thromboplastin time equal to 1.5× ULN (Note: if the patient is on anticoagulants, the International Normalized Ratio must be stable for at least 4 weeks prior to the first dose of IP and be within therapeutic range). 8. Female patients: a. Must be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), ORb. If of childbearing potential, must: i. Have a negative urine or serum pregnancy test at the screening visit and on admission to the study site on Day 1.ii. Agree not to attempt to become pregnant or donate ova from signing the informed consent form (ICF) until at least 90 days after the last dose of IP. iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from one month prior to screening until at least 90 days after the last dose of IP, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.9. Male patients:a. Must agree not to donate sperm from signing the ICF until at least 90 days after the last dose of IP.b. If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the ICF until at least 90 days after the last dose of IP.c. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the ICF until at least 5 days after the last dose of IP.10. Have suitable venous access for blood sampling.11. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion Criteria2
- Have ongoing toxicities equal to Grade 2 according to National Cancer Institute CTCAE Version 5.0 (excluding alopecia, fatigue, sensory neuropathy, or adequately treated immune-related endocrine deficiency).
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.3. Have a corrected QT interval (using Fridericia’s correction formula) (QTcF) of greater than 470 msec (females) and greater than 450 msec (males).4. Active, uncontrolled bacterial, viral, fungal, or infections requiring systemic therapy.5. Conditions requiring systemic treatment with corticosteroids or any other form of immunosuppressive therapy that cannot be tapered to stop at least 14 days prior to dosing.6. Patients with a history of the following treatments within the specified timeframe prior to SL 28 therapy (Day 1).a. Immune checkpoint inhibitors/biologics within 28 days prior to Day 1. b. Antineoplastic drugs (including chemotherapy, molecular targeted therapy, antibody therapy, hormone therapy, endocrine therapy, immunotherapy, etc.), surgical therapy, radiotherapy, or radiopharmaceuticals within 21 days prior to Day 1.c. Any other unapproved drugs within a period equivalent to 5 half-lives prior to Day 1.d. Nitrosoureas or mitomycin C within 6 weeks prior to Day 1.e. Patients receiving localized palliative radiation (not inclusive of the primary tumour location) can be permitted after discussion with the Sponsor.7. Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer not requiring treatment, ductal carcinoma-in-situ of the breast, and superficial nonmuscle invasive urothelial carcinoma (excluding T1 lesions and CIS).8. Female patient who is pregnant or breast-feeding. 9. Have known history of human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (HCV) (anti-HCV positive).10. Unwillingness or inability to comply with procedures required in this protocol.11. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the patient’s ability to participate in the study.12. History or presence of serious cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 6 months determined by the PI (or delegate) to be clinically relevant.13. Presence or having sequelae of GI, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.14. Use of any live vaccinations within 28 days prior to screening.Participation in another clinical study of an investigational drug or investigational device within 30 days of the investigational drug prior to screening
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Interventions
Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The purpose of this open-label, multi-centre clinical trial is to evaluate the anti-tumour activity, safety, and pharmacokinetics of single-agent SL-28 in patients with a diverse array of solid tumours. The study includes an initial Phase 1 dose-escalation segment to determine the recommended Phase 2 dose(s) for SL-28 as a monotherapy, followed by Phase 2 expansion cohorts evaluating SL-28 either as a monotherapy or in combination with standard-of-care therapy. The study will enroll patients with advanced solid tumours, including those who have failed previous lines of chemotherapy and immunotherapy. The therapy is administered in a controlled clinical setting to ensure appropriate monitoring and adherence to the intervention. SL-28 Intervention (Phases 1 and 2): Doses administered: 3×10^7 cells/injection and 6×10^7 cells/injection, once daily, 5 days per week Mode of administration: intravenous push Phase 2 – Additional Details: Participants will receive SL-28 together with the locally accepted standard-of-care regimen for their specific tumour type. Standard-of-care may include supportive-care medications, administered according to institutional guidelines and the treating investigator’s judgment. No experimental or investigational SOC therapies will be used. Dose assignment for Phase 2 participants: Participants in Phase 2 will be assigned to one of the two SL-28 dose levels (3×10^7 or 6×10^7 cells/injection) based on the recommended Phase 2 dose identified during Phase 1. Participants will not undergo intra-patient dose escalation. Each cohort will independently examine safety, pharmacokinetics, and anti-tumour activity at its assigned dose level. Duration of administration: 12 weeks, 5 days per week
Locations(1)
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ACTRN12625001342404