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Taking people in ItalyPhase 1

Tests Sofe-M in adults with selected advanced solid tumors

Tests whether Sofe-M is safe and tolerable in adults with advanced solid tumors.

Key facts

Who runs it
Eli Lilly and Company
Where
Milan, ItalySee the 2 sitesAlso in 6 other countries, 23 sites
Trial code
Registry title
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
575 people, planned
Started
20 May 2024
Expected to end
Jun 2029
Type of study
Interventional, 11 groups
Treatments tested
  • Sofe-M
  • bevacizumab
  • carboplatin
  • Itraconazole
  • pembrolizumab
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain advanced solid tumors: ovarian, endometrial, cervical, non-small cell lung, triple negative breast, pancreatic or colorectal cancer. It tests the study drug Sofe-M (Sofetabart Mipitecan, LY4170156).

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced solid tumors. Which cancer types can join depends on the study part: dose escalation (ovarian, endometrial, cervical, non-small cell lung, triple negative breast, pancreatic or colorectal cancer), dose optimization (ovarian and endometrial cancer), dose expansion (low grade serous ovarian, cervical, non-small cell lung, triple negative breast and high grade endometrioid cancer).
Earlier treatment
People with serious unresolved side effects from earlier treatment cannot join.

Main reasons for not taking part

  • Known or suspected uncontrolled spread of cancer to the brain or spinal cord
  • History of carcinomatous meningitis
  • Active uncontrolled infection (bacterial, viral, fungal or parasitic)
  • Corneal keratopathy or a past corneal transplant
  • Pregnant or breastfeeding, or planning to breastfeed during the study or within 30 days of the last dose

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Any serious unresolved toxicities from prior therapy
  • 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
  • Significant cardiovascular disease
  • History of pneumonitis/interstitial lung disease
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
  • Individual with known or suspected uncontrolled central nervous system (CNS) metastases
  • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Where in Italy

Also in 6 other countries, 23 sites

  • Humanitas Mirasole S.p.A.Milan, ItalyTaking people
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people

About the trial

What the trial wants to find out

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.

The 11 groups in the trial

  • Sofe-M (Dose-escalation, Cohort A1)Treatment being tested

    Escalating doses of Sofe-M administered intravenously (IV)

    Treatment: Sofe-M

  • Sofe-M (Cohort A1 Parts A and C)Treatment being tested

    Sofe-M administered IV

    Treatment: Sofe-M

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

    Sofe-M administered IV and itraconazole administered orally

    Treatment: Sofe-M and Itraconazole

  • Sofe-M (Dose-optimization, Cohort A2)Treatment being tested

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

    Treatment: Sofe-M

  • Sofe-M (Enrichment Cohort A3)Treatment being tested

    Monotherapy administered IV

    Treatment: Sofe-M

  • Sofe-M (Combination Cohort A4)Treatment being tested

    Combination with bevacizumab administered IV

    Treatment: Sofe-M and bevacizumab

  • Sofe-M (Combination Cohort A5)Treatment being tested

    Combination with carboplatin administered IV

    Treatment: Sofe-M and carboplatin

  • Sofe-M Combination with Pembrolizumab (Dose-optimization Cohort A6)Treatment being tested

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

    Treatment: Sofe-M and pembrolizumab

  • Sofe-M Combination with carboplatin and optional bevacizumab (Dose-optimization Cohort A7)Treatment being tested

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

    Treatment: Sofe-M, bevacizumab, and carboplatin

  • Sofe-M (Dose-expansion, Cohort B2-B4)Treatment being tested

    Sofe-M administered IV

    Treatment: Sofe-M

  • Sofe-M (Dose-expansion, Cohort B1)Treatment being tested

    Sofe-M administered IV

    Treatment: Sofe-M

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests Sofe-M in adults with selected advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
4 November 2026