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

NCT06400472 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 188632024-511238-11-00J5E-OX-JZXALOXO-FRA-24001
• Study Type: interventional
• Target: 575
• Locations: 7 countries
• Sites: 24

Brief 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.

Conditions

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

Keywords

Folate receptor alpha; NSCLC; Ovarian cancer; Cervical cancer; Endometrial cancer; Solid tumor; Lung cancer; Breast cancer; Pancreatic cancer; Colorectal cancer; Anti-drug conjugate; Phase I; Chemotherapy; sofe-m

Outcome Measures

Primary Outcomes (7)

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

  Number of participants with dose-limiting toxicities (DLTs)

  1 Cycle (21 or 28 days)

• Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab

  Number of participants with DLTs

  1 Cycle (21 or 28 days)

• Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin

  Number of participants with DLTs

  1 Cycle (21 or 28 days)

• Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab

  Number of participants with DLTs

  1 Cycle (21 or 28 days)

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

  ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

  Up to Approximately 60 Months or 5 Years

• Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR

  ORR per RECIST 1.1

  Up to Approximately 60 Months or 5 Years

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

  A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

  Up to Approximately 60 Months or 5 Years

Secondary Outcomes (15)

• To characterize the pharmacokinetics (PK) properties of Sofe-M (LY4170156): Minimum Plasma Concentration (Cmin)

  First 4 Cycles (84 days)

• To characterize the PK properties of Sofe-M (LY4170156): Cmin with bevacizumab or carboplatin

  First 4 Cycles (Approximately 84 days)

• To characterize the PK properties of Sofe-M (LY4170156): Cmin with pembrolizumab

  First 4 Cycles (84 days)

• To characterize the PK properties of Sofe-M (LY4170156): Area under the concentration versus time curve (AUC)

  First 4 Cycles (84 days)

• To characterize the patient-reported outcomes (PRO) Common Terminology Criteria for Adverse Events (CTCAE) of Sofe-M (LY4170156)

  Up to Approximately 60 Months or 5 Years

Study Arms (11)

Sofe-M (Dose-escalation, Cohort A1)

EXPERIMENTAL

Escalating doses of Sofe-M administered intravenously (IV)

Drug: Sofe-M

Sofe-M (Cohort A1 Parts A and C)

EXPERIMENTAL

Sofe-M administered IV

Drug: Sofe-M

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

EXPERIMENTAL

Sofe-M administered IV and itraconazole administered orally

Drug: Sofe-M; Drug: Itraconazole

Sofe-M (Dose-optimization, Cohort A2)

EXPERIMENTAL

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

Drug: Sofe-M

Sofe-M (Enrichment Cohort A3)

EXPERIMENTAL

Monotherapy administered IV

Drug: Sofe-M

Sofe-M (Combination Cohort A4)

EXPERIMENTAL

Combination with bevacizumab administered IV

Drug: Sofe-M; Drug: bevacizumab

Sofe-M (Combination Cohort A5)

EXPERIMENTAL

Combination with carboplatin administered IV

Drug: Sofe-M; Drug: carboplatin

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

EXPERIMENTAL

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

Drug: Sofe-M; Drug: pembrolizumab

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

EXPERIMENTAL

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

Drug: Sofe-M; Drug: bevacizumab; Drug: carboplatin

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

EXPERIMENTAL

Sofe-M administered IV

Drug: Sofe-M

Sofe-M (Dose-expansion, Cohort B1)

EXPERIMENTAL

Sofe-M administered IV

Drug: Sofe-M

Interventions

bevacizumab DRUG

IV

Sofe-M (Combination Cohort A4); Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)

carboplatin DRUG

IV

Sofe-M (Combination Cohort A5); Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)

Itraconazole DRUG

oral

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

Sofe-M DRUG

Intravenous

Also known as: sofetabart mipitecan, LY4170156

Sofe-M (Cohort A1 Parts A and C); Sofe-M (Combination Cohort A4); Sofe-M (Combination Cohort A5); Sofe-M (Dose-escalation, Cohort A1); Sofe-M (Dose-expansion, Cohort B1); Sofe-M (Dose-expansion, Cohort B2-B4); Sofe-M (Dose-optimization, Cohort A2); Sofe-M (Enrichment Cohort A3); Sofe-M Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B); Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6); Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)

pembrolizumab DRUG

IV

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (24)

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92037, United States

RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

NOT YET RECRUITING

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546, United States

RECRUITING

NYU Langone Health - Long Island

Mineola, New York, 11501, United States

RECRUITING

New York University (NYU) Clinical Cancer Center

New York, New York, 10016, United States

RECRUITING

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The Ohio State University (OSU) Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4000, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

Cancer Research SA

Adelaide, 5000, Australia

RECRUITING

Icon Cancer Centre South Brisbane

QLD, 4101, Australia

RECRUITING

Centre Leon Berard

Lyon, 69373, France

RECRUITING

Institut de Cancerologie de l'Ouest - site St-Herblain

Saint-Herblain, 44805, France

RECRUITING

Oncopole Claudius Regaud

Toulouse, 31059, France

RECRUITING

Humanitas San Pio X

Milan, 20159, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Tokyo, 104-0045, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Related Links

• A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

MeSH Terms

Conditions

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

Interventions

Bevacizumab; Carboplatin; Itraconazole; pembrolizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

FR (3); KR (1); US (10); ES (3); JP (3); AU (2); IT (2)