SL-28 for Advanced Solid Tumours

January 13, 2026 updated by: Second Life Therapeutics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Hollywood Private Hospital
        • Contact:
          • Adnan Khattak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SL-28 Low Dose
Biological: SL-28

Doses administered: 3×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

Mode of administration: intravenous push

Biological: SL-28

Doses administered: 6×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

Mode of administration: intravenous push

Biological: SL-28
Doses administered: to-be-determeined-later Mode of administration: intravenous push
Experimental: SL-28 Intermediate Dose
Biological: SL-28

Doses administered: 3×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

Mode of administration: intravenous push

Biological: SL-28

Doses administered: 6×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

Mode of administration: intravenous push

Biological: SL-28
Doses administered: to-be-determeined-later Mode of administration: intravenous push
Experimental: SL-28 High Dose
Biological: SL-28

Doses administered: 3×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

Mode of administration: intravenous push

Biological: SL-28

Doses administered: 6×10^7 cells/injection, once daily, 5 days per week, 12 weeks.

Mode of administration: intravenous push

Biological: SL-28
Doses administered: to-be-determeined-later Mode of administration: intravenous push

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events
Time Frame: 12 weeks
Treatment-emergent adverse events will be assessed and graded by the investigator according to the CTCAE v5
12 weeks
To evaluate the safety and tolerability of SL-28 by determining the incidence of dose-limiting toxicitieswithin the first 28 days after infusion.
Time Frame: 12 weeks
Assessment of dose limiting toxicities assessed by the occurrence of treatment-emergent adverse events(TEAEs) graded by the Investigator per the National Cancer Institute Common Terminology Criteria forAdverse Events, version 5.0.
12 weeks
Change from baseline in ECG QT interval
Time Frame: 12 weeks
Electrocardiograms will be recorded using a 12-lead ECG machine, and the QT interval (milliseconds) will be evaluated and summarized as change from baseline.
12 weeks
Number of participants with dose-limiting toxicities (DLTs)
Time Frame: 12 weeks
Dose-limiting toxicities will be assessed during the DLT evaluation period as defined in the protocol.
12 weeks
Change from baseline in vital signs
Time Frame: 12 weeks
Vital signs including systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)will be measured using standard clinical equipment and summarized as change from baseline.
12 weeks
Change from baseline in vital signs
Time Frame: 12 weeks
Vital signs: Heart rate (beats per minute) will be measured using standard clinical equipment and summarized as change from baseline.
12 weeks
Change from baseline in vital signs
Time Frame: 12 weeks
Vital signs: body temperature (°C) will be measured using standard clinical equipment and summarized as change from baseline.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) per RECIST 1.1
Time Frame: 12 weeks
Objective response rate will be defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by CT or MRI imaging.
12 weeks
Objective Response Rate (ORR) per iRECIST
Time Frame: 12 weeks
Objective Response Rate (ORR) per iRECIST
12 weeks
Disease Control Rate (DCR) per RECIST 1.1
Time Frame: 12 weeks
Disease control rate will be defined as the proportion of participants achieving CR, PR, or stable disease (SD) according to RECIST version 1.1.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Life Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL-28-FIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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