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AzTrials

Lung Cancer, Nonsmall CellPhase 1/2NCT05860296

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

A Phase 1/2 study testing SLC-391 and pembrolizumab in people with Lung Cancer, Nonsmall Cell and Lung Cancer Stage IV, run by SignalChem Lifesciences Corporation at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase AXL with desirable potency and pharmaceutical properties. The study is being done to evaluate the safety and pharmacokinetic (PK) profile of SLC-391 in combination with pembrolizumab in participants with non-small cell lung… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SLC-391 and pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
12 sitesin 2 countries
Study dates
31 May 2023to 1 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject provides written informed consent.
  • Adults ≥ 18 years of age on day of signing informed consent.
  • 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.
  • Phase 1b Subjects additional eligibility criteria:
  • Subjects must have received a minimum of one prior systemic treatment for advanced unresectable or metastatic NSCLC and progressed following prior SOC.
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  • Maximum of up to 4 prior lines of therapy in an advanced or metastatic setting is allowed.
  • Subjects who had disease recurrence or progression following neoadjuvant or adjuvant therapy or definitive chemoradiation therapy are eligible.
  • Subjects who received treatment with an approved/available targeted therapy for an actionable genomic alteration (including but not limited to EGFR, ALK, ROS1, KRAS, etc.) can participate if they have documented disease progression or were unable to tolerate the approved targeted therapy.
  • Phase 1b Notes:
  • Targeted therapy for advanced setting is counted as a prior line of therapy.
  • Prior use of a PD(L)-1, anti-CTLA-4 (Cytotoxic T-lymphocyte associated protein 4) antibody, or any other antibody or drug that specifically targets immune checkpoint pathway is allowed and is counted as a prior line of therapy.
  • Neoadjuvant and adjuvant therapies initiated < 12 months prior to the first dose of study drug(s) will be counted as one prior line of therapy for advanced setting.
  • Neoadjuvant and adjuvant therapies initiated ≥ 12 months prior to the first dose of study drug(s) are not counted as prior lines of therapy.
  • Maintenance therapy is not counted as a prior line of therapy.
  • Phase 2a Subjects additional eligibility criteria:
  • Cohort 1:
  • Tumors must have PD-L1 expression (TPS ≥ 1% as determined by SOC).
  • Subjects are eligible to participate if they did not receive any prior therapy (SOC or investigational) or prior immunotherapy of any kind for advanced or metastatic disease. See Exclusion Criteria 1.0.
  • Subjects with disease recurrence or progression following neoadjuvant or adjuvant therapy or definitive chemoradiation therapy are eligible.
  • Prior adjuvant or neoadjuvant immunotherapy is allowed if completed more than 12 months before documented relapse.
  • Cohort 2:
  • Subjects should have received at least 2 doses of an approved anti PD(L) 1 monoclonal antibody (mAb) in an advanced or metastatic setting.
  • Progressive disease should be documented during treatment or within 12 weeks from the last dose of anti-PD(L)-1 mAb.
  • Up to a maximum of 2 prior lines of approved 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, is allowed.
  • Subjects who received treatment with an approved/available targeted therapy for an actionable genomic alteration (including but not limited to EGFR, ALK, ROS1, KRAS, etc.) can participate if they have documented disease progression or 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.
  • Subjects with disease recurrence or progression following neoadjuvant or adjuvant therapy or definitive chemoradiation therapy are eligible.
  • Cohort 2 Notes:
  • Targeted therapy for advanced setting is counted as a prior line of therapy.
  • Maintenance therapy is not counted as a prior line of therapy.
  • Neoadjuvant and adjuvant therapies initiated < 12 months prior to first dose of study drug(s) will be counted as one prior line of therapy for advanced setting.
  • Neoadjuvant and adjuvant therapies initiated ≥ 12 months prior to first dose of study drug(s) are not counted as prior lines of therapy.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 3 months.
  • An archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated must exist to participate in the study (Mandatory in Phase 2a but subjects in Phase 1b may be enrolled in the absence of a tumor tissue sample). Only core needle and/or excisional biopsy samples, from archival or fresh tissue, will be accepted in this study.
  • Adequate organ function as defined below must be met for subjects to participate in the study. Clinical laboratory specimens must be collected within 10 days prior to first dose of study drug(s):
  • Absolute neutrophil count (ANC) ≥ 1500/µL or ≥ 1.5 × 109/L (in the absence of growth factor support).
  • Platelets ≥ 100,000/µL or 100 × 109/L (in the absence of transfusion or growth factor support).
  • Hemoglobin ≥ 9 g/dL or ≥ 90 g/L (in the absence of transfusion). Note: Criteria must be met without packed red blood cell transfusion within the prior 2 weeks. Subjects can be on stable dose of erythropoietin (≥ approximately 3 months).
  • Creatinine Clearance (CCr) ≥ 50 mL/minute using the Cockcroft and Gault formula.
  • Note: The Cockcroft and Gault formula (1973): CCr = ([{140 - age} × weight]/[72 × SCr]) × 0.85 (if female); where CCr = mL/minute; age = years; weight = kg; SCr (serum creatinine) = mg/dL.
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (unless a diagnosis of Gilbert's syndrome in which case ≤ 3 × ULN) OR direct bilirubin ≤ 1 × ULN for participants with total bilirubin >1.5 × ULN.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5× ULN for subjects with liver metastases).
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; if the subject is receiving anticoagulant therapy PT or INR should be within the therapeutic range of the intended use of anticoagulants.
  • Activated partial thromboplastin time/partial thromboplastin time (aPTT/PTT) ≤ 1.5 × ULN; if the subject is receiving anticoagulant therapy PTT should be within the therapeutic range of intended use of anticoagulants.
  • Note: Low molecular weight heparin, warfarin (INR monitoring required), direct oral anticoagulants, and drugs in the anticoagulant class (e.g., Lovenox [enoxaparin]) administered for deep vein thrombosis are permitted.
  • Women who are not of childbearing potential must be documented and will not be tested for pregnancy or required to utilize contraception if they meet one or more of the following definitions of non-childbearing potential:
  • Amenorrheic for > 2 years without a hysterectomy and oophorectomy, and a follicle stimulating hormone (FSH) value in the postmenopausal range upon screening evaluation.
  • Post-hysterectomy, bilateral oophorectomy, or tubal ligation. Tubal ligation should be confirmed with medical records of the actual procedure.
  • 12. Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum) within 72 hours prior to first dose of study drug(s) and meet the following criteria throughout the study, starting with the screening visit through 120 days after the last dose of study drug(s) (or 30 days if new cancer therapy is initiated):
  • Agrees to follow contraceptive guidance throughout the study as per protocol.
  • Willing to use 2 highly effective birth control methods throughout the study. The 2 birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. Refer to Appendix 4 for complete list of acceptable birth control methods.
  • Refrain from egg donation. Note: If there is any question that a subject will not reliably comply with the requirements for contraception, that subject should not be enrolled.
  • Male subjects must agree to use an acceptable method of contraception and refrain from sperm donation throughout the study: from screening, during the treatment period, and for at least 120 days after the last dose of study drug(s) (or 30 days if new cancer therapy is initiated).
  • Willing and able to participate in blood sampling and all other required study procedures.

Who cannot join

  • Phase 2a - Cohort 1 (only) exclusion criteria:
  • 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)).
  • Undergone prior treatment with a known AXL inhibitor such as bemcentinib (see Section 8.2.2 for full list of AXL inhibitors).
  • Received prior systemic anticancer therapy within 5 half-lives or 3 weeks, whichever is shorter, prior to starting the first dose of study drug(s). Examples of prior systemic anticancer therapy includes cytotoxic agents, targeted therapy such as small molecules, mAbs and hormonal therapy etc..
  • Received immunotherapies [including but not limited to PD(L)-1 inhibitors, etc.] within 4 weeks prior to starting the first dose of study drug(s).
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  • Received prior radiotherapy within 2 weeks of the first dose of study drug(s) or had a history of radiation pneumonitis.
  • Note: Subjects must have recovered from all radiation-related toxicities and not require corticosteroids. A 1 week washout is permitted following palliative radiation (≤ 2 weeks of radiotherapy) for non-central nervous system (CNS) disease.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug(s).
  • Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent, follow-up is primarily non-invasive, and the subject can comply with protocol requirements.
  • Has not recovered to ≤ Grade 1 or to baseline from prior cancer therapy toxicity.
  • Note: Subject with ≤ Grade 2 neuropathy may be an exception to this criterion and may qualify for the study after discussion with Sponsor. Subjects with endocrine-related AEs ≤ Grade 2 requiring treatment or hormone replacement may be eligible after discussion with Sponsor.
  • Note: Toxic effects also include laboratory results that have not resolved to ≤ Grade 1. Subjects with ≤ Grade 2 alopecia are an exception to this criterion.
  • Has not adequately recovered from major surgery and/or complications from the procedure prior to the first dose of study drug(s).
  • Pulmonary hemorrhage or hemoptysis > 2.5 mL blood within 6 weeks of screening (or within 2 weeks if the source of bleeding is treated).
  • Received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug(s). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines are generally killed virus vaccines and are permitted; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live-attenuated vaccines and are not allowed.
  • Note: The administration of killed vaccines, mRNA vaccines, and DNA vaccines is allowed.
  • Has an active diagnosis of immunodeficiency or is receiving systemic steroid therapy (exceeding 10 mg daily of prednisone equivalent) or has received any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug(s).
  • Has active autoimmune disease which required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Note: Hormone therapy (e.g., thyroxine, insulin, or corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Known additional malignancy that is progressing or has required active treatment within the past 2 years.
  • Note: Subjects with curatively treated basal or squamous cell carcinoma of the skin (non-melanoma skin cancer), cervical or vaginal intra-epithelial neoplasia, non-invasive breast cancer in situ, or localized prostate cancer with a prostate-specific antigen level of < 4 ng/mL (µg/L) at screening are not excluded. Subjects with other curatively treated malignancies who have had a > 2-year disease-free interval and whose natural history or treatment does not have the potential to interfere with investigational agents (e.g., hormone maintenance) may be enrolled after approval by the Medical Monitor/Sponsor.
  • Known active CNS metastases and/or carcinomatous meningitis. Subjects with adequately treated brain metastases may participate provided they meet the following criteria:
  • Are radiologically stable (no progression) for at least 4 weeks as documented by screening computed tomography (CT) or magnetic resonance imaging (MRI) scan.
  • Clinically stable.
  • No evidence of new or enlarging brain metastases. Does not require steroids for at least 14 days before starting first dose of study drug(s) (anticonvulsants at a stable dose are allowed). Low dose steroids equivalent of prednisone ≤ 10 mg orally once a day is allowed.
  • No history of intracranial or spinal cord hemorrhage.
  • No evidence of significant vasogenic edema.
  • Severe hypersensitivity (≥ Grade 3) to pembrolizumab or SLC-391 and/or any excipients.
  • A history of non-infectious pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • A known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies). No HIV testing is required unless mandated by the local health authority.
  • Known history of Hepatitis B (Anti-HBc and HBsAg reactive) or known active Hepatitis C virus (RNA, qualitative) infection.
  • Note: No testing for Hepatitis B or C is required unless mandated by a local health authority.
  • A history or current evidence of any severe acute or chronic medical or psychiatric condition that requires treatment, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject, in the opinion of the Principal Investigator (PI; also referred to as Investigator). Examples include, but are not limited to, active uncontrolled infection (including tuberculosis [TB]) requiring systemic therapy, transfusion dependent anemia, recent (within 90 days) stroke or myocardial infarction, unstable angina, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, symptomatic congestive heart failure (New York Heart Association class ≥ III/IV), and recent severe Coronavirus disease 2019 (COVID-19).
  • Note: TB testing is required for subjects recently exposed to persons with active TB or who have traveled recently to areas where TB is endemic.
  • Systolic blood pressure (BP) ≥ 160 mmHg or diastolic BP ≥100 mmHg.
  • Has a corrected QT interval by Fridericia (QTcF) ≥ 470 msec. Note: Apply the Fridericia QT correction to calculate QTcF using the following formula: QTcF = QT/RR1/3 where QT = the time between the start of the QRS complex and the end of the T wave and RR = the time between the start of one QRS complex and the start of the next QRS complex.
  • Note: If a subject has a prolonged QT interval and the prolongation is deemed to be due to a pacemaker as deemed by the Investigator (i.e., the subject otherwise has no cardiac abnormalities), the subject may be eligible to participate in the study following discussion with the Sponsor.
  • History or presence of sustained or symptomatic bradycardia (≤ 55 bpm), left bundle branch block, ventricular arrhythmia excluding premature ventricular contractions, or uncontrolled ventricular arrhythmia. Subjects with a supraventricular arrhythmia requiring medical treatment and a normal ventricular rate are eligible.
  • Psychological, familial, sociological, or geographical conditions including known psychiatric or substance abuse disorder that could interfere with the subject's ability to provide informed consent, comply with the protocol, or interfere with the interpretation of the study results.
  • Inability to swallow oral medication and/or the presence of active gastrointestinal (GI) disease and/or other GI conditions, including bowel resection, that is expected to interfere significantly with the absorption, distribution, metabolism, or excretion of oral SLC-391 therapy.
  • Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of study drug(s).
  • Had an allogenic tissue, marrow, or solid organ transplant.
  • Females who are pregnant or nursing. Note: SLC reserves the right to deny any subject enrollment based upon potential safety concern(s) or factors that could confound the study results.
  • Note: The Investigator or licensed, medically qualified Sub-Investigator must review and confirm eligibility prior to the first dose of study drug(s).

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States6 sites

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Community Health Network

    Indianapolis, Indiana, 46250

  • Horizon Verdi Oncology

    Lafayette, Indiana, 47905

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

Other trials in United States

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • London Regional Cancer Centre

    London, Ontario

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

Other trials in Canada

About this study

Official title: An Open-Label, Phase 1b/2a Study of SLC-391, an AXL Inhibitor, in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase AXL with desirable potency and pharmaceutical properties.

The study is being done to evaluate the safety and pharmacokinetic (PK) profile of SLC-391 in combination with pembrolizumab in participants with non-small cell lung cancer (NSCLC).

Read more

Each treatment cycle lasts 21 days. Participants will swallow SLC-391 pills two times every day. Participants will get pembrolizumab intravenously (IV) from the study site staff on the first day of every cycle.

This study has 2 parts. The first part will determine the recommended dose of SLC-391 in combination with pembrolizumab. The second part wants to find out if the combination of SLC-391 and pembrolizumab can help stop NSCLC tumours from growing or spreading.

Being tested
SLC-391, pembrolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLC-391Drug

    SLC-391 is an AXL inhibitor

  • pembrolizumabBiological

    Also called KEYTRUDA®

    Immunotherapy

Study groups in NCT05860296
Study groupRoleWhat they receive
Dose Escalation (Phase 1b Dose Level 1)ExperimentalDose 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.
Receives: Drug: SLC-391; Biological: pembrolizumab
Dose Escalation (Phase 1b Dose Level 2)ExperimentalDose 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).
Receives: Drug: SLC-391; Biological: pembrolizumab
Dose Escalation (Phase 1b Dose Level -1)ExperimentalDose 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).
Receives: Drug: SLC-391; Biological: pembrolizumab
ICI-Naïve (Phase 2a)ExperimentalThe 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.
Receives: Drug: SLC-391; Biological: pembrolizumab
ICI-Resistant (Phase 2a)ExperimentalThe 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.
Receives: Drug: SLC-391; Biological: pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    After a minimum of 3 evaluable subjects have completed the 21-day DLT (Dose Limiting Toxicity) evaluation period, SRC will review all available safety, efficacy, PK, and pharmacodynamic data and determine whether to expand the current dose level or escalate or de-escalate.

    A subject is considered "evaluable" for dose-decisions during Phase 1b if the subject has completed the 21-day DLT evaluation period and has received at least 75% of the planned dose of study drug during the DLT evaluation period, or the subject has experienced a DLT. The number of subjects experiencing a DLT will inform the SRC's decision on whether to expand, escalate or de-escalate.

    AEs are defined using NCI-CTCAE v5.0 and DLTs include events ≥ Grade 3 in severity with some exceptions.

    Measured: DLTs will be evaluated during the during the first 21 days of treatment Cycle 1 in the Phase 1b portion of the study.

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

    To assess AEs as criteria of safety of oral SLC-391 in combination with pembrolizumab

    Measured: From first dose through 90-days following cessation of SLC-391 and pembrolizumab

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

    Proportion of subjects who have achieved complete response (CR) or partial response (PR), evaluated using RECIST 1.1 for tumor assessment.

    Measured: From date of baseline tumor assessment to the date of first documented CR or PR, assessed up to 24 months.

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

    To assess AEs as criteria of safety of oral SLC-391 in combination with pembrolizumab(PR), evaluated using RECIST 1.1 for tumor assessment.

    Measured: From first dose through 90-days following cessation of SLC-391 and pembrolizumab

Secondary outcomes (10)

  1. Phase 2a: Optimal Biological Dose (OBD) of SLC-391 in combination with pembrolizumab.

    Optimal Biological Dose

    Measured: Up to 24 months

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

    To assess AEs as criteria of safety of oral SLC-391 in combination with pembrolizumab

    Measured: From first dose through 90-days following cessation of SLC-391 and pembrolizumab

  3. Phase 1b and Phase 2a: Plasma levels of SLC-391 when administered in combination with pembrolizumab

    Pharmacokinetics of blood sample (plasma) levels of SLC-391 will be analyzed using validated high-performance liquid chromatography with tandem quadrupole mass spectrometry detection

    Measured: On Day 1 of Cycles 1,2,4,6,8,10,12 (each cycle is 21 days) and the date of first objective response by RECIST 1.1, assessed up to 24 months.

  4. Phase 1b: ORR of participants treated with SLC-391 in combination with pembrolizumab

    ORR by RECIST (RECIST) as assessed by investigators. Defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR), evaluated using RECIST 1.1 based on Investigator assessment.

    Measured: Up to 24 months

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

    Disease control rate (DCR) by RECIST 1.1 as assessed by investigators. Defined as as the percentage of subjects achieving CR, PR, or SD (Stable disease) as assessed by the Investigator per RECIST 1.1.

    Measured: Up to 24 months

  6. Phase 1b and Phase 2a:Time-to-response (TTR) of participants treated with SLC-391 in combination with pembrolizumab

    Time-to-response (TTR) by RECIST 1.1 as assessed by investigators.

    Measured: 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.

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

    Duration of response (DoR) by RECIST 1.1 as assessed by investigators

    Measured: From date of first objective response to the date of first objective evidence of disease progression or death by RECIST 1.1, assessed up to 24 months.

  8. Phase 1b and Phase 2a: Progression-free survival (PFS) of participants treated with SLC-391 in combination with pembrolizumab

    Progression-free survival (PFS) by RECIST 1.1 as assessed by investigators

    Measured: From the date of first dose of study drug(s) to the date of first objective evidence of disease progression or death from any cause, whichever is earlier, assessed up to 24 months.

  9. Phase 1b and Phase 2a: Time-to-progression (TTP) of participants treated with SLC-391 in combination with pembrolizumab

    Time-to-progression (TTP) by RECIST 1.1 as assessed by investigators

    Measured: From the date of the first dose of study drug(s) to the date of first objective evidence of disease progression by RECIST 1.1, assessed up to 24 months.

  10. Phase 1b and Phase 2a: Overall Survival (OS) of participants treated with SLC-391 in combination with pembrolizumab

    Overall Survival

    Measured: From the date of first dose to the date of death by any cause, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2023
  2. Study start31 May 2023
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Why it stopped: Lack of efficacy and enrollment challenges

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05860296
Sponsor's protocol ID
SLC-391-102
Other IDs
KEYNOTE-C62, MK3475-C62
Status last verified
Dec 2025
First submitted
27 Apr 2023
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Z, Morrison D, Lu L, Singh M, Yan J, Leighl N, Laurie SA, Hotte S. First-in-Human Phase I Clinical Trial of SLC-391, a Novel and Selective AXL Inhibitor, in Patients with Advanced Solid Tumours. Pharmaceuticals (Basel). 2025 Dec 17;18(12):1898. doi: 10.3390/ph18121898.

    PubMed 41471387

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SLC-391 and pembrolizumab in people with Lung Cancer, Nonsmall Cell and Lung Cancer Stage IV, run by SignalChem Lifesciences Corporation at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 55 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy and enrollment challenges). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Determine doses of SLC-391 in combination with pembrolizumab for further evaluation in Phase 2a. (time frame: DLTs will be evaluated during the during the first 21 days of treatment Cycle 1 in the Phase 1b portion of the study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05860296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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