SL-28 for Advanced Solid Tumours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Second Life Therapeutics is evaluating SL-28, a non-genetically modified cell-based therapy, in a multi-center, open-label study for adults with various advanced solid cancers. The trial starts with a Phase 1 dose-escalation to identify safe and potentially effective doses, followed by Phase 2 expansion cohorts. Participants receive SL-28 as a single-agent treatment over 12 weeks on a 5-days-on, 2-days-off schedule, with monitoring for safety, pharmacokinetics, and anti-tumor activity. Eligibility includes unresectable or metastatic cancers that have progressed after standard therapies, across multiple tumor types such as head and neck, lung, pancreatic, colorectal, and others. The study aims to determine the highest safe dose and to observe any signals of clinical activity in this diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)
* NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG
* QTcF \>470 ms (females) or \>450 ms (males)
* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
* Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing
* Prior therapies within restricted timeframes:
* Immune checkpoint inhibitors or biologics within 28 days
* Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days
* Unapproved investigational drugs within 5 half-lives
* Nitrosoureas or mitomycin C within 6 weeks
* Concurrent malignancy within 5 years, except specified low-risk cancers
* Pregnancy or breastfeeding
* Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection
* Inability or unwillingness to comply with protocol procedures
* History of anaphylaxis or significant allergy interfering with participation
* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months
* Conditions affecting drug absorption, distribution, metabolism, or excretion
* Receipt of live vaccines within 28 days prior to screening
* Participation in another investigational study within 30 days prior to screening

Where it's running

• The Southern Oncology Clinical Research Unit (SOCRU)
  Adelaide, South Australia, Australia Recruiting
• Liverpool Hospital
  Sydney, New South Wales, Australia Not yet recruiting
• John Flynn Private Hospital
  Gold Coast, Queensland, Australia Not yet recruiting

Study contacts

• Study coordinator: George Tetz, MD, PhD
• Email: clinical@secondlifetx.com
• Phone: 16466173088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.