Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
A Multicenter Phase 1-2A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of LNS8801 in Patients With Advanced Cancer With and Without Pembrolizumab
3 other identifiers
interventional
200
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2019
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2027
December 18, 2025
December 1, 2025
7.2 years
October 10, 2019
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events observed for LNS8801 dosed alone and in combination with pembrolizumab
Duration of study, approximately 24 months
Secondary Outcomes (3)
LNS8801 plasma exposure (AUC) as a function of dose
During first 23 days of dosing
LNS8801 plasma exposure (Cmax) as a function of dose
During the first 23 days of dosing
LNS8801 plasma exposure (t1/2) as a function of dose
During the first 23 days of dosing
Study Arms (1)
Active
OTHERPhase 1/2 open-label
Interventions
pembrolizumab- anti-PD-1 antibody
LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
Eligibility Criteria
You may qualify if:
- Has histopathologically confirmed locally advanced or metastatic solid tumor cancer.
- Is able to understand and voluntarily sign a written informed consent form and is willing and able to comply with protocol requirements.
You may not qualify if:
- Has histopathologically confirmed locally advanced or metastatic solid tumor cancer (or lymphoma in Phase 1). The solid tumor cancer is further defined in some cohorts as:
- Phase 1B monotherapy expansion cohort:
- Has melanoma, except uveal melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy.
- Monotherapy Cohort M2:
- Has pancreatic, gastric, non small cell lung cancer (NSCLC), or colorectal cancer.
- Monotherapy Cohort M3:
- Has cutaneous melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy.
- Monotherapy Cohort M4:
- Has any solid tumor malignancy, except cutaneous melanoma, and has previously received anti-PD-1/L1 therapy and is now not eligible for anti-PD-1 treatment in the judgement of the Investigator due to prior severe immune related adverse events, and has not received intervening cancer therapy since the anti-PD-1/L1 therapy.
- Monotherapy Cohort M5:
- Has metastatic uveal melanoma, and has received ≤ 2 prior lines of prior systemic therapy.
- Phase 1B combination expansion cohort:
- Has any locally advanced or metastatic solid tumor cancer, and has first had a clinical benefit from, followed by documented disease progression on an anti-PD-1/L1 treatment administered either as monotherapy or in combination. Clinical benefit is defined as a complete or partial response of any duration or stable disease for at least 16 weeks with at least one scan showing stable disease. Patients should not have received intervening therapy that did not include anti-PD1/L1 between finishing anti-PD-1/L1 treatment and commencing study treatment.
- Disease progression on an anti-PD-1/L1 therapy is defined as both:
- Having received anti-PD-1/L1 therapy at least twice if dosed every 4 weeks (q4w) or longer, at least 3 times if dosed every 3 weeks (q3w), or at least 4 times if dosed every 2 weeks (q2w) and,
- +77 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linnaeus Therapeutics, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (10)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Yale Cancer Center
New Haven, Connecticut, 06519, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87106, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
The START Center for Cancer Care
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tina Garyantes, PhD
Linnaeus Therapeutics, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 17, 2019
Study Start
October 21, 2019
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 15, 2027
Last Updated
December 18, 2025
Record last verified: 2025-12