臨床研究等提出・公開システム

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)

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors (J5E-OX-JZXA)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Pending

Aug. 19, 2024

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

-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

-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

Both

-Solid tumor

Drug: LY4170156
Intravenous
[Study Arms]
-Experimental: LY4170156 (Dose-escalation, Cohort A1)
Escalating doses of LY4170156 administered intravenously (IV).
Intervention: Drug: LY4170156
-Experimental: LY4170156 (Dose-optimization, Cohort A2)
Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV.
Intervention: Drug: LY4170156
-Experimental: LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2)
LY4170156 administered IV.
Intervention: Drug: LY4170156

-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)

+81-3-3520-0111

July. 26, 2024

No

United States