Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers
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ClinicalTrials.gov Identifier: NCT05860296 |
Recruitment Status :
Recruiting
First Posted : May 16, 2023
Last Update Posted : April 26, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | April 27, 2023 | ||||||||
First Posted Date ICMJE | May 16, 2023 | ||||||||
Last Update Posted Date | April 26, 2024 | ||||||||
Actual Study Start Date ICMJE | May 31, 2023 | ||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Testing Experimental Anti-cancer Drug SLC-391 With an Approved Immunotherapy Drug, Pembrolizumab, for Advanced Lung Cancers | ||||||||
Official Title ICMJE | 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) | ||||||||
Brief 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 cancer (NSCLC). 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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
98 | ||||||||
Original Estimated Enrollment ICMJE |
102 | ||||||||
Estimated Study Completion Date ICMJE | December 2027 | ||||||||
Estimated Primary Completion Date | December 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Phase 1b Notes:
Cohort 1:
Cohort 2:
Cohort 2 Notes:
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.
Exclusion Criteria:
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.
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.
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.
Note: The administration of killed vaccines, mRNA vaccines, and DNA vaccines is allowed.
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.
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.
Note: No testing for Hepatitis B or C is required unless mandated by a local health authority.
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.
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.
Note: The Investigator or licensed, medically qualified Sub-Investigator must review and confirm eligibility prior to the first dose of study drug(s). |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, United States | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT05860296 | ||||||||
Other Study ID Numbers ICMJE | SLC-391-102 KEYNOTE-C62 ( Other Identifier: Merck Sharp & Dohme LLC ) MK3475-C62 ( Other Identifier: Merck Sharp & Dohme LLC ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | SignalChem Lifesciences Corporation | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | SignalChem Lifesciences Corporation | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Merck Sharp & Dohme LLC | ||||||||
Investigators ICMJE |
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PRS Account | SignalChem Lifesciences Corporation | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |