A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors

Study Identifier:
LOXO-FRA-24001 (J5E-OX-JZXA)
CT.gov Identifier:
NCT06400472
EudraCT Identifier:
202451123811
EU Trial (CTIS) Number:
2024-511238-11-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.

Key endpoints were safety, PK, and antitumor activity per RECIST v1.1. Efficacy evaluable pts were those who had a post baseline response assessment or discontinued treatment prior to the response assessment.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Primary Peritoneal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: The study has 2 phases: phase 1a dose escalation/dose optimization and phase 1b dose expansion. Dose escalation follows the mTPI-2 method. Pts are allowed to backfill to previously cleared dose levels that have demonstrated therapeutically relevant exposures or shown direct evidence of clinical activity. LY4170156 is administered intravenously Q3W; DLT evaluation period is 21 days. In dose expansion, pts with select tumor types are enrolled into 4 cohorts: PROC with high (cohort B1) and moderate/low (cohort B2) FR expression and select advanced/metastatic non-ovarian cancer with high (cohort C1) and moderate/low FR expression (cohort C2).
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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, TNBC, and high grade endometrioid cancer
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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Nehal Lakhani
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Primary Peritoneal
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Ovarian
Pancreas
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Primary Peritoneal