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Checkpoint Inhibitor

SLC-391 + Pembrolizumab for Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by SignalChem Lifesciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease must be measurable per RECIST 1.1, as assessed by the Site(s) Investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in these lesions.

Subject has histologically or cytologically documented, locally advanced (Stage IIIB or IIIC) disease (not candidate for surgical resection, local therapies with curative intent, or definitive chemoradiation) or the subject has metastatic NSCLC (Stage IV). Staging will be based on the American Joint Committee on Cancer, Eighth Edition. Subjects with adenocarcinoma, large cell carcinoma, undifferentiated carcinoma, squamous carcinoma, or mixed histology are eligible. Subjects with a small cell component are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose of study drug(s) to the date of first objective response by recist 1.1, assessed up to 24 months.

Awards & highlights

Study Summary

This trial is studying a pill and an injection to see if they can help stop the growth of non-small cell lung cancer.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have a life expectancy of at least 3 months and are in relatively good physical condition. They must have received prior treatments, including an anti-PD(L)-1 monoclonal antibody unless they couldn't tolerate it. Participants should not be pregnant or nursing, agree to use contraception if applicable, and cannot have certain severe health conditions or allergies.Check my eligibility

What is being tested?

The trial is testing SLC-391, a new drug that targets a specific protein involved in cancer growth, alongside Pembrolizumab, an approved immunotherapy drug. The study has two parts: the first part determines the best dose of SLC-391 when used with Pembrolizumab; the second part checks if this combination can halt tumor growth in NSCLC.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from Pembrolizumab IV treatment, fatigue, digestive issues like nausea or diarrhea from oral SLC-391 pills and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer can be measured by scans and has grown in previously treated areas.

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My lung cancer is advanced but not suitable for surgery or aimed cure treatments.

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I have had at least one treatment for my advanced lung cancer and it has gotten worse.

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My cancer came back or got worse after initial treatment.

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My tumor shows PD-L1 activity.

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I have not received any treatment for my advanced or metastatic disease.

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My cancer came back or got worse after initial treatment.

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I have received at least 2 doses of a PD-1 or PD-L1 inhibitor for advanced cancer.

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My cancer got worse during or within 3 months after my last anti-PD(L)-1 treatment.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of study drug(s) to the date of first objective response by recist 1.1, assessed up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of study drug(s) to the date of first objective response by recist 1.1, assessed up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of study drug(s) to the date of first objective response by recist 1.1, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b: Determine doses of SLC-391 in combination with pembrolizumab for further evaluation in Phase 2a.

Phase 1b: Number of Participants with Adverse Events (AEs) as assessed by CTCAE V5.0

Phase 2a: Antitumor activity of SLC-391 (objective response rate [ORR]) in combination with pembrolizumab, using RECIST version 1.1

+1 more

Secondary outcome measures

Phase 1b and Phase 2a: Disease control rate (DCR) of participants treated with SLC-391 in combination with pembrolizumab

Phase 1b and Phase 2a: Duration of response (DoR) of participants treated with SLC-391 in combination with pembrolizumab

Phase 1b and Phase 2a: Number of Participants with Adverse Events (AEs) as assessed by CTCAE V5.0

+7 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: ICI-Resistant (Phase 2a)Experimental Treatment2 Interventions

The dose of SLC-391 will be randomized between two dose levels as approved by the SRC in combination with Pembrolizumab. Up to 2 prior lines therapy in an advanced or metastatic setting allowed Must have received at least 2 doses of an approved anti-PD(L)-1 inhibitor and disease progressed either during treatment or within 12 weeks from last dose of anti-PD(L)-1 therapy Subjects who received treatment with a targeted therapy for an actionable genomic alteration with can participate if there is documented progressive disease or they were unable to tolerate the approved targeted therapy. Only these subjects are allowed to receive up to a maximum of 3 prior lines of cancer therapy in an advanced or metastatic setting. A subject may continue treatment with SLC-391 and pembrolizumab in 21-day cycles until the treatment discontinuation criteria are met.

Group II: ICI-Naïve (Phase 2a)Experimental Treatment2 Interventions

The dose of SLC-391 will be randomized between two dose levels as approved by the SRC in combination with Pembrolizumab. Tumors must have PD-L1 expression (TPS ≥1%) No prior systemic treatment (chemotherapy or targeted therapy) and no prior immunotherapy (SOC or investigational) in advanced or metastatic setting Subjects with actionable genomic alterations with approved targeted therapy in first line setting are not allowed Subjects with disease recurrence or progression following neoadjuvant or adjuvant therapy or definitive chemoradiation therapy are eligible. Prior adjuvant, neoadjuvant immunotherapy allowed if completed more than 12 months before documented relapse A subject may continue treatment with SLC-391 and pembrolizumab in 21-day cycles until the treatment discontinuation criteria are met.

Group III: Dose Escalation (Phase 1b Dose Level 2)Experimental Treatment2 Interventions

Dose level 2 dose will be SLC-391 150 mg PO/BID on Days 1-21 of each cycle and Pembrolizumab 200 mg IV on Day 1 of each cycle. All dose-escalation decisions and the rationale for progressing to the next cohort will be reviewed by the Safety Review Committee (SRC).

Group IV: Dose Escalation (Phase 1b Dose Level 1)Experimental Treatment2 Interventions

Dose level 1 dose will be SLC-391 100 mg PO/BID on Days 1-21 of each cycle and Pembrolizumab 200 mg IV on Day 1 of each cycle. All dose-escalation decisions and the rationale for progressing to the next cohort will be reviewed by the Safety Review Committee (SRC). A subject may continue treatment with SLC-391 and pembrolizumab in 21-day cycles until the treatment discontinuation criteria are met.

Group V: Dose Escalation (Phase 1b Dose Level -1)Experimental Treatment2 Interventions

Dose level -1 dose will be SLC-391 50 mg PO/BID on Days 1-21 of each cycle and Pembrolizumab 200 mg IV on Day 1 of each cycle. All dose-escalation decisions and the rationale for progressing to the next cohort will be reviewed by the Safety Review Committee (SRC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

SLC-391

2022

Completed Phase 1

~60

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

SignalChem Lifesciences CorporationLead Sponsor

3 Previous Clinical Trials

87 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,048 Total Patients Enrolled

Zaihui Zhang, PhDStudy DirectorSignalChem LifeSciences

1 Previous Clinical Trials

35 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05860296 — Phase 1 & 2

Lung Cancer Research Study Groups: ICI-Naïve (Phase 2a), ICI-Resistant (Phase 2a), Dose Escalation (Phase 1b Dose Level 1), Dose Escalation (Phase 1b Dose Level 2), Dose Escalation (Phase 1b Dose Level -1)

Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05860296 — Phase 1 & 2

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05860296 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the geographic reach of this trial?

"This research is currently recruiting 9 sites located in Lafayette, Detroit, Nashville and other cities. To reduce any travelling burdens associated with enrollment, it's suggested to select the closest location possible."

Answered by AI

Are there any new opportunities to join this experiment?

"This medical trial, which was first shared on May 1st 2023 and subsequently updated 3 days later, is not presently enrolling patients. Although recruitment for this study has paused, there are currently over 2000 other trials actively in need of participants."

Answered by AI

What is the ultimate aim of this clinical investigation?

"According to the information provided by SignalChem Lifesciences Corporation, the primary outcome of this trial will be evaluated over a 21 day period and is defined as Number of Participants with Adverse Events (AEs) as assessed by CTCAE V5.0. Additionally, researchers will evaluate secondary outcomes such as Overall Response Rate (ORR) for patients treated with SLC-391 in combination with pembrolizumab measured using immune-RECIST (iRECIST), Disease Control Rate (DCR) calculated per RECIST 1.1 and iRECIST guidelines, and Time-to-Response (TTR)"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers

2023. "Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05860296.

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