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SL-28 for Advanced Solid Tumours

ConditionsHead & Neck CancerPancreas CarcinomaPancreas Cancer, MetastaticLung AdenocarcinomaLung Cancer (NSCLC)Lung Cancer (Non-Small Cell)Esophageal CancerStomach (Gastric) CancerLiver CancerIntestinal CancerBladder CancerRenal CancerProstate CancerMelanoma (Skin Cancer)Breast CancerOvarian CancerEndometrial CancerColorectal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Life Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • SL-28

    Biological/Vaccine

    Doses administered: 3×10\^7 cells/injection, once daily, 5 days per week, 12 weeks. Mode of administration: intravenous push

  • SL-28

    Biological/Vaccine

    Doses administered: 6×10\^7 cells/injection, once daily, 5 days per week, 12 weeks. Mode of administration: intravenous push

  • SL-28

    Biological/Vaccine

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: SL-28 Low DoseExperimental treatment 1 intervention
Group B: SL-28 Intermediate DoseExperimental treatment 1 intervention
Group C: SL-28 High DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-emergent adverse events

Treatment-emergent adverse events will be assessed and graded by the investigator according to the CTCAE v5

Time frame
12 weeks
2

To evaluate the safety and tolerability of SL-28 by determining the incidence of dose-limiting toxicitieswithin the first 28 days after infusion.

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.

Time frame
12 weeks
3

Change from baseline in ECG QT interval

Electrocardiograms will be recorded using a 12-lead ECG machine, and the QT interval (milliseconds) will be evaluated and summarized as change from baseline.

Time frame
12 weeks
4

Change from baseline in vital signs

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.

Time frame
12 weeks

Secondary outcomes

1

Objective Response Rate (ORR) per RECIST 1.1

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.

Time frame
12 weeks
2

Objective Response Rate (ORR) per iRECIST

Objective Response Rate (ORR) per iRECIST

Time frame
12 weeks
3

Disease Control Rate (DCR) per RECIST 1.1

Disease control rate will be defined as the proportion of participants achieving CR, PR, or stable disease (SD) according to RECIST version 1.1.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Life Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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