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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last up to approximately 5 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Sofetabart Mipitecan (Sofe-M) in people with certain advanced solid tumors. It looks at how safe the drug is, how well people handle its side effects, and whether it works. The study will last up to about 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the dose-raising part: Have ovarian cancer, cancer of the belly lining or fallopian tubes, cancer of the womb lining or cervix, non-small cell lung cancer, triple-negative breast cancer, pancreatic cancer, or colon or rectal cancer. Ovarian cancer must be the epithelial type, which starts in cells covering the ovary.
  • For the part that compares doses: Have epithelial ovarian cancer, cancer of the belly lining or fallopian tubes, or cancer of the womb lining.
  • For the parts that test doses in more people: Have low-grade serous ovarian cancer (a slower-growing type), cervical cancer, non-small cell lung cancer, triple-negative breast cancer, or high-grade endometrioid cancer (a faster-growing type).

Who can't join

  • Cancer is known or thought to have spread to the brain or spinal cord and is not controlled.
  • Have ever had cancer in the lining around the brain and spinal cord.
  • Have an active infection affecting the body that is not controlled, caused by bacteria, viruses, fungi, or parasites.
  • Have signs of damage to the clear front layer of the eye, or have had a transplant of this layer.
  • Still have serious side effects from past treatment.
  • Have major heart or blood vessel disease, or a heart test shows a QTcF of 470 milliseconds or more (a delay in the heart's electrical reset between beats).
  • Have a history of lung inflammation or interstitial lung disease, which affects tissue around the lungs' air sacs.
  • Are pregnant, breastfeeding, or plan to breastfeed during the study or within 30 days after the last dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (11)

AZ

CA

  • University of California, San Diego (UCSD) - Moores Cancer Center · La Jolla, CA 92037 · Study contact · 858-657-7000Ramez Eskander · Principal investigatorMore trials in La Jolla

GA

MI

NY

  • NYU Langone Health - Long Island · Mineola, NY 11501Bhavana Pothuri · Principal investigatorMore trials in Mineola
  • New York University (NYU) Clinical Cancer Center · New York, NY 10016 · Study contact · 212-731-5100Bhavana Pothuri · Principal investigatorMore trials in New York
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center · New York, NY 10065Chrisann Kyi · Principal investigatorMore trials in New York

OH

  • The Ohio State University (OSU) Wexner Medical Center · Columbus, OH 43210David O'Malley · Principal investigatorMore trials in Columbus

TX

  • The University of Texas - MD Anderson Cancer Center · Houston, TX 77030-4000Shannon Westin · Principal investigatorMore trials in Houston

UT

VA