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New treatment option for Head & Neck Cancer
Official title SL-28 for Advanced Solid Tumours
ClinicalTrials.gov ID: NCT07341737
What this study is testing
What is SL-28?
SL-28 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for head & neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the...
- 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...
You likely can't join if
- 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:
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.