A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor a-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors - J5E-OX-JZXA

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240270

Enrollment

220

Registered

2024-08-09

Start date

2024-08-30

Completion date

Unknown

Last updated

2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug: LY4170156 Intravenous [Study Arms] -Experimental: LY4170156 (Dose-escalation, Cohort A1) Escalating doses of LY4170156 administered intravenously (IV). Intervention: Drug: LY4170156 -Experimen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Have one of the following solid tumor cancers: -Cohort A1: 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, and colorectal cancer (CRC) -Cohort A2/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer -Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or pancreatic cancer

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
-Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 [ Time Frame: First 4 Cycles (21 days) ] Number of participants with dose-limiting toxicities (DLTs) -Phase 1a: To determine the RP2D or optimal dose of LY4170156 [ Time Frame: First 4 Cycles (21 days) ] Number of participants with DLTs -Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR) [ Time Frame: Up to Approximately 48 Months or 4 Years ] ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	—

Measure

Time frame

-Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 [ Time Frame: First 4 Cycles (21 days) ] Number of participants with dose-limiting toxicities (DLTs) -Phase 1a: To determine the RP2D or optimal dose of LY4170156 [ Time Frame: First 4 Cycles (21 days) ] Number of participants with DLTs -Phase 1b: To assess the antitumor activity of LY4170156 Monotherapy: Overall response rate (ORR) [ Time Frame: Up to Approximately 48 Months or 4 Years ] ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

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Countries

Japan, United States

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results