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Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab

NCT04130516 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-18

No results posted yet for this 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

  • Solid Tumor, Adult

Interventions

DRUG

LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER

LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER

BIOLOGICAL

Pembrolizumab - anti-PD-1 antibody

pembrolizumab- anti-PD-1 antibody

Sponsors & Collaborators

Principal Investigators

  • Tina Garyantes, PhD · Linnaeus Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2026-12-31
Completion
2027-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130516 on ClinicalTrials.gov