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LY4170156

Phase 1

Ovarian Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Sep 4, 2026

Target and mechanism

Molecular targetFRα
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment495

FDA Designations

No designations recorded

Clinical trial landscape

LY4170156 · 1 trial · 7 indications

Phase 1 1
NCT06400472A Study of Sofe-M in Participants With Selected Advanced Solid TumorsOvarian Neoplasms
RECRUITING575 Analytics
PHASE1RECRUITING
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Ovarian NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)
1 Cycle (21 or 28 days)

Number of participants with dose-limiting toxicities (DLTs)

Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab
1 Cycle (21 or 28 days)

Number of participants with DLTs

Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin
1 Cycle (21 or 28 days)

Number of participants with DLTs

Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab
1 Cycle (21 or 28 days)

Number of participants with DLTs

Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)
Up to Approximately 60 Months or 5 Years

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR
Up to Approximately 60 Months or 5 Years

ORR per RECIST 1.1

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Up to Approximately 60 Months or 5 Years

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints

To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)
First 4 Cycles (84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin
First 4 Cycles (Approximately 84 days)
To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab
First 4 Cycles (84 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sofe-M (Dose-escalation, Cohort A1)EXPERIMENTALEscalating doses of Sofe-M administered intravenously (IV)
Sofe-M (Cohort A1 Parts A and C)EXPERIMENTALSofe-M administered IV
Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)EXPERIMENTALSofe-M administered IV and itraconazole administered orally
Sofe-M (Dose-optimization, Cohort A2)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV
Sofe-M (Enrichment Cohort A3)EXPERIMENTALMonotherapy administered IV
Sofe-M (Combination Cohort A4)EXPERIMENTALCombination with bevacizumab administered IV
Sofe-M (Combination Cohort A5)EXPERIMENTALCombination with carboplatin administered IV
Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab
Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)EXPERIMENTALComparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab
Sofe-M (Dose-expansion, Cohort B2-B4)EXPERIMENTALSofe-M administered IV
Sofe-M (Dose-expansion, Cohort B1)EXPERIMENTALSofe-M administered IV

Interventions

NameTypeDescription
Sofe-MDRUGIntravenous
bevacizumabDRUGIV
carboplatinDRUGIV
ItraconazoleDRUGoral
pembrolizumabDRUGIV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Have one of the following solid tumor cancers: * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, o...

Countries:United StatesAustraliaFranceItalyJapanSouth KoreaSpain
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Recent Changes (Last 90 Days)

MEDIUMSep 4, 2026NCT06400472Enrollment: 495 → 575
LOWJun 18, 2026NCT06400472lastUpdatePostDate: changed
LOWJun 18, 2026NCT06400472lastUpdatePostDate: changed
LOWJun 18, 2026NCT06400472lastUpdatePostDate: changed

Frequently asked questions about LY4170156

What is LY4170156 used for?

LY4170156 is an investigational small molecule being developed for the treatment of ovarian neoplasms. It is also being studied in other advanced solid tumors, including endometrial, cervical, non-small-cell lung, triple negative breast, pancreatic, and colorectal cancers, according to the ongoing clinical trial.

What does LY4170156 target?

LY4170156 targets the folate receptor alpha (FRα), a protein that is often overexpressed in certain cancers. By targeting FRα, the drug is designed to interfere with cancer cell growth and survival. This mechanism is being evaluated in a Phase 1 clinical trial for advanced solid tumors.

Who makes LY4170156?

LY4170156 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is currently conducting a Phase 1 clinical trial to evaluate the drug's safety and efficacy in patients with selected advanced solid tumors.

What phase is LY4170156 in?

LY4170156 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug in advanced solid tumors, including ovarian cancer.

What clinical trials is LY4170156 in?

LY4170156 is being studied in a Phase 1 clinical trial with the identifier NCT06400472. This trial is titled 'A Study of LY4170156 in Participants With Selected Advanced Solid Tumors' and is currently recruiting participants. The trial is expected to enroll approximately 495 participants across multiple countries.

Is LY4170156 the same as other drugs?

LY4170156 is a unique investigational drug developed by Eli Lilly and Company. No alternative names for this drug have been disclosed. It is a small molecule that targets the folate receptor alpha (FRα) and is being studied for the treatment of ovarian neoplasms and other advanced solid tumors.