NCT04099277 is a Phase 1 clinical trial of LY3435151 in Solid Tumor, sponsored by Eli Lilly and Company.

Who is sponsoring NCT04099277?

NCT04099277 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT04099277?

Interventions in NCT04099277: LY3435151, Pembrolizumab.

What condition does NCT04099277 study?

NCT04099277 studies Solid Tumor, Triple-negative Breast Cancer, Gastric Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Cervical Carcinoma, High Grade Serous Ovarian Carcinoma, Hepatocellular Carcinoma, Undifferentiated Pleomorphic Sarcoma, Leiomyosarcoma.

Is NCT04099277 still recruiting?

NCT04099277 is currently terminated. Last updated 31 August 2021.

Are results published for NCT04099277?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-08-31 · How we verify

NCT04099277

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of LY3435151 in Participants With Solid Tumors

Terminated Phase 1 Results posted Last updated 31 August 2021

What this trial tests

Phase 1 trial testing LY3435151 in Solid Tumor in 2 participants. Terminated before completion.

Timeline

28 October 2019

Primary endpoint
5 March 2020

5 March 2020

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	28 October 2019
Primary completion	5 March 2020
Estimated completion	5 March 2020
Sites	2 locations across Japan, United States

Drugs / interventions tested

LY3435151 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →
Triple-negative Breast Cancer — all drugs for Triple-negative Breast Cancer →
Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Solid Tumor or Triple-negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151 Secondary · Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151.

Group	Value	95% CI
10 mg LY3435151	NA	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 4 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

10 mg LY3435151

Serious: 1/2 (50%)

Deaths: 0/2

Serious adverse events (1 terms)

Reaction	System	10 mg LY3435151
Dehydration	Metabolism and nutrition disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	10 mg LY3435151
Vomiting	Gastrointestinal disorders	—
Thoracic vertebral fracture	Injury, poisoning and procedural complications	—
Electrocardiogram qt prolonged	Investigations	—
Troponin i increased	Investigations	—
Hyperkalaemia	Metabolism and nutrition disorders	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Dizziness	Nervous system disorders	—
Anxiety	Psychiatric disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Orthostatic hypotension	Vascular disorders	—

Most-reported serious reactions: Dehydration.

Data from ClinicalTrials.gov NCT04099277 adverse events section.

Sponsor's own description

The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

TIGIT in cancer immunotherapy.
Chauvin JM, Zarour HM. · · 2020 · cited 567× · PMID 32900861 · DOI 10.1136/jitc-2020-000957
Inflammatory Mechanisms of HCC Development.
Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641
Poliovirus receptor (PVR)-like protein cosignaling network: new opportunities for cancer immunotherapy.
Wu B, Zhong C, Lang Q, Liang Z, et al · · 2021 · cited 45× · PMID 34433460 · DOI 10.1186/s13046-021-02068-5
Emergence of the CD226 Axis in Cancer Immunotherapy.
Conner M, Hance KW, Yadavilli S, Smothers J, et al · · 2022 · cited 30× · PMID 35812451 · DOI 10.3389/fimmu.2022.914406
Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
Revisiting T-cell adhesion molecules as potential targets for cancer immunotherapy: CD226 and CD2.
Jo Y, Sim HI, Yun B, Park Y, et al · · 2024 · cited 18× · PMID 39349829 · DOI 10.1038/s12276-024-01317-9
Tumor Microenvironment Drives the Cross-Talk Between Co-Stimulatory and Inhibitory Molecules in Tumor-Infiltrating Lymphocytes: Implications for Optimizing Immunotherapy Outcomes.
Franzese O. · · 2024 · cited 17× · PMID 39684559 · DOI 10.3390/ijms252312848
Sophisticated roles of tumor microenvironment in resistance to immune checkpoint blockade therapy in hepatocellular carcinoma.
Zhang YZ, Ma Y, Ma E, Chen X, et al · · 2025 · cited 8× · PMID 40051497 · DOI 10.20517/cdr.2024.165

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04099277 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 31 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04099277.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing