OncoMatch/Clinical Trials/NCT04130516
Study Assessing MTD, Safety, Tolerability, PK and Anti-tumor Effects of LNS8801alone and With Pembrolizumab
Is NCT04130516 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Pembrolizumab - anti-PD-1 antibody and LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER for solid tumor, adult.
Treatment: LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER · Pembrolizumab - anti-PD-1 antibody — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: PD-L1 (CD274) (Tumor Proportion Score (TPS) ≥1% and ≤49%)
metastatic NSCLC expressing PD-L1 with a Tumor Proportion Score (TPS) ≥1% and ≤49% as determined by an FDA-approved test
Required: EGFR wild-type
must not have EGFR or ALK genomic tumor aberrations
Required: ALK wild-type
must not have EGFR or ALK genomic tumor aberrations
Disease stage
Metastatic disease required
Has histopathologically confirmed locally advanced or metastatic solid tumor cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy
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
Must have received: anti-PD-1/PD-L1 therapy
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
Cannot have received: GPER agonist (tamoxifen, raloxifene, estrogen hormone replacement therapy)
Exception: History of oral contraceptive use is permissible
Has had any prior treatment for the present solid malignancy with GPER agonists (eg, tamoxifen, raloxifene, or estrogen hormone replacement therapy). History of oral contraceptive use is permissible.
Cannot have received: allogeneic hematopoietic stem cell transplantation
Exception: Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of acute graft versus host disease [GVHD]
must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years
Lab requirements
Blood counts
Absolute neutrophil count >=1.5 × 10^9/L (>=1500/mm3); Hemoglobin >=9.0 g/dL or equivalent; Platelet count >=75 × 10^9/L (>=75,000/mm3) for LNS8801 monotherapy cohorts, >=100 × 10^9/L (>=100,000/mm3) for LNS8801/pembrolizumab combination cohorts
Kidney function
Measured or calculated creatinine clearance (glomerular filtration rate) >=50 mL/min/1.73 m2
Liver function
Total bilirubin <=1.5 × institutional upper limit of normal (ULN), unless known Gilbert syndrome has been diagnosed; ALT and AST <=2.5 × ULN or <=5 × ULN with cancer in the liver
Cardiac function
QTc by Fridericia method <=450 msec for male patients or <=470 msec for female patients
Have adequate organ and bone marrow function defined by: Absolute neutrophil count >=1.5 × 10^9/L (>=1500/mm3). Hemoglobin >=9.0 g/dL or equivalent. Platelet count >=75 × 10e9/L (>=75,000/mm3) for LNS8801 monotherapy cohorts Platelet count >=100 × 10e9/L (>=100,000/mm3) for LNS8801/pembrolizumab combination cohorts. Total bilirubin <=1.5 × institutional upper limit of normal (ULN), unless known Gilbert syndrome has been diagnosed. Measured or calculated creatinine clearance (glomerular filtration rate) >=50 mL/min/1.73 m2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 × ULN or <=5 × ULN with cancer in the liver. For cohorts receiving LNS8801/pembrolizumab combination therapy, prothrombin time (PT) or activated partial thromboplastin time (aPTT) must be ≤1.5 × ULN. If a participant is receiving anticoagulant therapy, PT or aPTT must be within therapeutic range of intended use of anticoagulants. QTc by Fridericia method >450 msec for male patients or >470 msec for female patients [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cedars-Sinai Medical Center · Los Angeles, California
- Yale Cancer Center · New Haven, Connecticut
- Massachusetts General Hospital · Boston, Massachusetts
- University of New Mexico Comprehensive Cancer Center · Albuquerque, New Mexico
- Columbia University Herbert Irving Comprehensive Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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