Study of LP-184 in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT05933265 |
Recruitment Status :
Recruiting
First Posted : July 6, 2023
Last Update Posted : May 16, 2024
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Sponsor:
Lantern Pharma Inc.
Information provided by (Responsible Party):
Lantern Pharma Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | June 23, 2023 | ||||
First Posted Date ICMJE | July 6, 2023 | ||||
Last Update Posted Date | May 16, 2024 | ||||
Actual Study Start Date ICMJE | June 9, 2023 | ||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence and severity of AEs [ Time Frame: 12 months ] Incidence and severity of AEs graded according to the NCI CTCAE, version 5.0, clinical laboratory and ECG abnormalities defined as DLTs
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of LP-184 in Patients With Advanced Solid Tumors | ||||
Official Title ICMJE | A Phase 1A Dose Escalation Study of LP-184 in Patients With Advanced or Metastatic Solid Tumors. | ||||
Brief Summary | The primary objective of this study is to evaluate the safety, tolerability, MTD and RP2D of LP-184 in patients with advanced solid tumors who have relapsed from or are refractory to standard therapy or for whom no standard therapy is available. The secondary objectives are to characterize the PK of LP-184 and its metabolites in plasma and assess clinical activity of LP-184. | ||||
Detailed Description | Patients who meet all eligibility criteria will be enrolled to receive treatment with LP-184 at a dose determined based on the available cohort at the time of each patient's enrollment. Patients will receive LP-184 infusion during Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, PK, and clinical activity. Dose escalation is planned with minimum of 3 patient cohorts (starting at dose level 1). After selection of the maximum tolerated dose (MTD), additional patients will be enrolled at two dose levels, including the MTD, as determined by the Safety Review Committee, until at least 10 patients each are treated at each dose to determine the recommended phase 2 dose. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumor | ||||
Intervention ICMJE | Drug: LP-184
LP-184 is a small molecule alkylating agent causing tumor cell death through DNA damage.
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Study Arms ICMJE | Experimental: Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184
Phase 1 Single Arm Multicenter Study to Assess the Safety and Tolerability of LP-184 in Patients with Advanced Solid Tumors
Intervention: Drug: LP-184
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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 |
30 | ||||
Original Estimated Enrollment ICMJE |
35 | ||||
Estimated Study Completion Date ICMJE | June 9, 2025 | ||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Patient Inclusion Criteria:
Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during study screening are eligible to enroll if all of the following criteria are met:
Patient Exclusion Criteria:
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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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05933265 | ||||
Other Study ID Numbers ICMJE | LTRN184-1AST23-1 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Lantern Pharma Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Lantern Pharma Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Lantern Pharma Inc. | ||||
Verification Date | May 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |