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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Linnaeus Therapeutics, Inc.
Study ID
NCT04130516
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER — DRUG
    LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
  • Pembrolizumab - anti-PD-1 antibody — BIOLOGICAL
    pembrolizumab- anti-PD-1 antibody

Study Details

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.

Key Dates

First listed
Oct 17, 2019
Start date
Oct 21, 2019
Status verified
Jul 2026
Primary completion
Jun 30, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Active
    Phase 1/2 open-label

Primary Outcome Measure

Adverse events observed for LNS8801 dosed alone and in combination with pembrolizumab [ Time Frame: Duration of study, approximately 24 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Yale Cancer CenterNew HavenConnecticut06519-
Massachusetts General HospitalBostonMassachusetts02114-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87106-
Columbia University Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19106-
MD Anderson Cancer CenterHoustonTexas77030-
The START Center for Cancer CareSan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Medical Center· Los Angeles, CAYale Cancer Center· New Haven, CTMassachusetts General Hospital· Boston, MAUniversity of New Mexico Comprehensive Cancer Center· Albuquerque, NMColumbia University Herbert Irving Comprehensive Cancer Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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