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NCT Number: NCT06400472

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

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.

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Ovarian Diseases Pancreatic Diseases Pancreatic Neoplasm Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Research SA, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofe-M

Drug

Intravenous

Other names: sofetabart mipitecan, LY4170156

Bevacizumab

Drug

IV

carboplatin

Drug

IV

Itraconazole

Drug

oral

Pembrolizumab

Drug

IV

Primary outcomes

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

    Time frame: 1 Cycle (21 or 28 days)

    Number of participants with dose-limiting toxicities (DLTs)

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

    Time frame: 1 Cycle (21 or 28 days)

    Number of participants with DLTs

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

    Time frame: 1 Cycle (21 or 28 days)

    Number of participants with DLTs

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

    Time frame: 1 Cycle (21 or 28 days)

    Number of participants with DLTs

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

    Time frame: Up to Approximately 60 Months or 5 Years

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

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

    Time frame: Up to Approximately 60 Months or 5 Years

    ORR per RECIST 1.1

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

    Time frame: Up to Approximately 60 Months or 5 Years

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

Secondary outcomes

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

    Time frame: First 4 Cycles (84 days)

    PK: Cmin of Sofe-M (LY4170156)

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

    Time frame: First 4 Cycles (Approximately 84 days)

    PK: Cmin of Sofe-M (LY4170156)

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

    Time frame: First 4 Cycles (84 days)

    PK: Cmin of Sofe-M (LY4170156)

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

    Time frame: First 4 Cycles (84 days)

    PK: AUC of Sofe-M (LY4170156)

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

    Time frame: Up to Approximately 60 Months or 5 Years

    PRO-CTCAE of Sofe-M (LY4170156)

  6. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR)

    Time frame: Up to Approximately 60 Months or 5 Years

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

  7. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Overall response rate (ORR) with bevacizumab or carboplatin or pembrolizumab

    Time frame: Up to Approximately 60 Months or 5 Years

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

  8. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR)

    Time frame: Up to Approximately 60 Months or 5 Years

    DOR per investigator assessed RECIST 1.1

  9. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Duration of response (DOR) with bevacizumab or carboplatin or pembrolizumab

    Time frame: Up to Approximately 60 Months or 5 Years

    DOR per investigator assessed RECIST 1.1

  10. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR)

    Time frame: Up to Approximately 60 Months or 5 Years

    TTR per investigator assessed RECIST 1.1

  11. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Time to response (TTR) with bevacizumab or carboplatin or pembrolizumab

    Time frame: Up to Approximately 60 Months or 5 Years

    TTR per investigator assessed RECIST 1.1

  12. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS)

    Time frame: Up to Approximately 60 Months or 5 Years

    PFS per investigator assessed RECIST 1.1

  13. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Progression free survival (PFS) with bevacizumab or carboplatin or pembrolizumab

    Time frame: Up to Approximately 60 Months or 5 Years]

    PFS per investigator assessed RECIST 1.1

  14. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR)

    Time frame: Up to Approximately 60 Months or 5 Years

    DCR per investigator assessed RECIST 1.1

  15. To evaluate the preliminary antitumor activity of Sofe-M (LY4170156): Disease control rate (DCR) with bevacizumab or carboplatin or pembrolizumab

    Time frame: Up to Approximately 60 Months or 5 Years

    DCR per investigator assessed RECIST 1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
May 6, 2024
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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