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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.

Must not have

Subjects have tumors that have actionable genomic alterations with approved targeted therapy in first line setting are not eligible to participate.

Subjects are not eligible if they received any prior therapy (SOC or investigational) for advanced or metastatic disease including chemotherapy, targeted therapy, or immunotherapy of any kind such as the following: pembrolizumab, an anti-PD(L)-1 or anti-programmed death ligand 2 (PD-L2) agent, or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX40 (Tumor necrosis factor receptor superfamily, member 4), CD137(Tumor necrosis factor receptor superfamily member 9)).

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer does not have genetic changes treatable with first-line targeted therapy.

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

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I have been treated with an AXL inhibitor like bemcentinib before.

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I haven't taken cancer drugs within the shortest of 5 half-lives or 3 weeks before starting the study drug.

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I have not taken any immunotherapy drugs in the last 4 weeks.

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I haven't had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.

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I still have significant side effects from previous cancer treatments.

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I am not currently on high-dose steroids or other drugs that weaken my immune system.

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I have an autoimmune disease treated with medication in the last 2 years.

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My cancer has spread to my brain or its coverings.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I have been diagnosed with HIV.

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I have a slow heartbeat or other specific heart rhythm issues.

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I have had lung radiation of more than 30 Gy in the last 6 months.

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I have received a transplant from another person.

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I am not pregnant or nursing.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 (50 mg and 100 mg PO/BID) as approved by the SRC in combination with Pembrolizumab. * Received at least 2 doses of anti-PD(L)-1 monoclonal antibody (mAb) in an advanced or metastatic setting. * Progressive disease documented during treatment or within 12 weeks from the last dose of anti-PD(L)-1 mAb. * Maximum of 2 prior lines of cancer therapy in an advanced or metastatic setting including an anti-PD(L)-1 mAb administered either as monotherapy or in combination with other therapies. * Subjects who received a targeted therapy for an actionable genomic alteration can participate with documented disease progression or if unable to tolerate the 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 (50 mg and 100 mg PO/BID) 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 3

~5890

SLC-391

2022

Completed Phase 1

~60