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NCT04130516 · ClinicalTrials.gov registry record · Phase 1
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
A Phase 1 study of Solid Tumor, Adult, sponsored by Linnaeus Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 10
- Study locations
NCT04130516: Recruiting Phase 1 study of Solid Tumor, Adult, sponsored by Linnaeus Therapeutics.
NCT04130516 is a Phase 1 study of Solid Tumor, Adult that is actively recruiting participants, run by Linnaeus Therapeutics. The registered enrollment target is 200 participants, roughly in line with the 188-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target. The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04130516, a Phase 1 study of Solid Tumor, Adult, is actively recruiting participants, sponsored by Linnaeus Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 10
- Study locations
Study Summary
This Phase 1/2, first-in-human, open-label, multicenter study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and antitumor effects of LNS8801 alone and in combination with pembrolizumab. The study will include a dose escalation phase, a dose expansion phase, and phase 2A cohorts. Up to 200 patients will be accrued for this study. Up to 15 study sites in the United States will participate in the study.
Conditions Studied
Interventions
- DRUG LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
- BIOLOGICAL Pembrolizumab - anti-PD-1 antibody
Study Locations (10)
New York
- Columbia University Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
- Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia
Texas
- MD Anderson Cancer Center - Houston
- The START Center for Cancer Care - San Antonio
California
- Cedars-Sinai Medical Center - Los Angeles
Connecticut
- Yale Cancer Center - New Haven
Massachusetts
- Massachusetts General Hospital - Boston
New Mexico
- University of New Mexico Comprehensive Cancer Center - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 1 |
What NCT04130516 shows while recruiting
NCT04130516 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 188-participant average among 72 other Solid Tumor, Adult trials with a reported enrollment target.
The record links to 1 condition, with Solid Tumor, Adult appearing as the primary indexed condition, and to 2 interventions - of which LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER is the first listed.
NCT04130516 lists 10 locations in 7 states (New York, Pennsylvania, Texas).
Frequently Asked Questions
What is clinical trial NCT04130516 about?
NCT04130516 is a clinical study titled "Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab". This Phase 1/2, first-in-human, open-label, multicenter study follows a 3+3 ascending dose escalation design to determine the MTD/RP2D and to characterize the safety, tolerability, PK, and antitumor effects of LNS8801 alone and in combination with pembrolizumab. The study will include a dose escalat...
What is the current status of trial NCT04130516?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2019-10-21. Estimated completion is 2027-12-15.
What conditions does trial NCT04130516 study?
This clinical trial studies the following conditions: Solid Tumor, Adult.
What interventions are being tested in trial NCT04130516?
The interventions under investigation include: LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER (DRUG), Pembrolizumab - anti-PD-1 antibody (BIOLOGICAL).
Who is sponsoring clinical trial NCT04130516?
This trial is sponsored by Linnaeus Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04130516 being conducted?
This trial has 10 study locations across California, Connecticut, Massachusetts, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04130516's enrollment target sits among peer trials
200 22nd of 72 higher than 49 of 72 other Solid Tumor, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor, Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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