NCT07341737

SL-28 for Advanced Solid Tumours

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Life Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Head & Neck Cancer
• Pancreas Carcinoma
• Pancreas Cancer, Metastatic
• Lung Adenocarcinoma
• Lung Cancer (NSCLC)
• Lung Cancer (Non-Small Cell)
• Esophageal Cancer
• Stomach (Gastric) Cancer
• Liver Cancer
• Intestinal Cancer
• Bladder Cancer
• Renal Cancer
• Prostate Cancer
• Melanoma (Skin Cancer)
• Breast Cancer
• Ovarian Cancer
• Endometrial Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2026-01-14
• Last updated: 2026-01-15

Locations

1 site across 1 country: Australia