A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Uterine Cervical Neoplasms; Ovarian Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Pancreatic Neoplasm; Endometrial Neoplasms

Treatments: Drug: bevacizumab; Drug: Sofe-M; Drug: carboplatin; Drug: Itraconazole; Drug: pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400472

LOXO-FRA-24001

J5E-OX-JZXA (Other Identifier)

18863

2024-511238-11-00

Details and patient eligibility

About

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.

Enrollment: 575 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

575 participants in 11 patient groups

Sofe-M (Dose-escalation, Cohort A1)

Experimental group

Description:

Escalating doses of Sofe-M administered intravenously (IV)

Treatment:

Drug: Sofe-M

Sofe-M (Cohort A1 Parts A and C)

Experimental group

Description:

Sofe-M administered IV

Treatment:

Drug: Sofe-M

Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)

Experimental group

Description:

Sofe-M administered IV and itraconazole administered orally

Treatment:

Drug: Itraconazole

Drug: Sofe-M

Sofe-M (Dose-optimization, Cohort A2)

Experimental group

Description:

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV

Treatment:

Drug: Sofe-M

Sofe-M (Enrichment Cohort A3)

Experimental group

Description:

Monotherapy administered IV

Treatment:

Drug: Sofe-M

Sofe-M (Combination Cohort A4)

Experimental group

Description:

Combination with bevacizumab administered IV

Treatment:

Drug: Sofe-M

Drug: bevacizumab

Sofe-M (Combination Cohort A5)

Experimental group

Description:

Combination with carboplatin administered IV

Treatment:

Drug: carboplatin

Drug: Sofe-M

Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)

Experimental group

Description:

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with pembrolizumab

Treatment:

Drug: pembrolizumab

Drug: Sofe-M

Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)

Experimental group

Description:

Comparing 2 or more doses (evaluated during dose escalation) of Sofe-M administered IV with or without bevacizumab

Treatment:

Drug: carboplatin

Drug: Sofe-M

Drug: bevacizumab

Sofe-M (Dose-expansion, Cohort B2-B4)

Experimental group

Description:

Sofe-M administered IV

Treatment:

Drug: Sofe-M

Sofe-M (Dose-expansion, Cohort B1)

Experimental group

Description:

Sofe-M administered IV

Treatment:

Drug: Sofe-M