RecruitingPhase 1

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

United States, Australia, France495 participantsStarted 2024-05-20

Plain-language summary

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, or colorectal cancer (CRC) * Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer * Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC Exclusion Criteria: * Individual with known or suspected uncontrolled central nervous system (CNS) metastases * Individual with history of carcinomatous meningitis * Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection * Individual with evidence of corneal keratopathy or history of corneal transplant * Any serious unresolved toxicities from prior therapy * Significant cardiovascular disease * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms) * History of pneumonitis/interstitial lung disease * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since LY4170156 is being tested in a Phase 1 trial where researchers are still figuring out the right dose, what does that mean for my safety, and how would side effects be monitored and managed if I were to participate?
2This trial is testing LY4170156 both alone and in combination with drugs like bevacizumab, carboplatin, and pembrolizumab — given my specific cancer type, which of these combinations, if any, would I potentially be assigned to, and how would that be decided?
3Because this is a Phase 1 dose-finding study, the focus is on safety rather than proven effectiveness — do you think enrolling in this trial makes sense for my situation right now, or would starting with a standard treatment first be a better path?
4The trial is measuring serious adverse events as a key outcome, which means safety is still being established — are there specific risks with LY4170156 that you'd want me to be aware of before I even consider discussing enrollment with the study team?
5My cancer type is one of several being studied here across a broad group — do you know whether there is any early signal from this trial or related research suggesting LY4170156 might be particularly relevant to my specific diagnosis?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156

Timeframe: 1 Cycle (21 days)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab

Timeframe: 1 Cycle (21 days)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin

Timeframe: 1 Cycle (21 days)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab

Timeframe: 1 Cycle (21 days)

Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)

Timeframe: Up to Approximately 48 Months or 4 Years

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

Timeframe: Up to Approximately 48 Months or 4 Years

Trial details

NCT IDNCT06400472

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559 LillyTrials@Lilly.com

View on ClinicalTrials.gov More Ovarian Neoplasms trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156

Timeframe: 1 Cycle (21 days)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab

Timeframe: 1 Cycle (21 days)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin

Timeframe: 1 Cycle (21 days)

Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab

Timeframe: 1 Cycle (21 days)

Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR)

Timeframe: Up to Approximately 48 Months or 4 Years

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

Timeframe: Up to Approximately 48 Months or 4 Years