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NCT Number: NCT06400472

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 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, and TNBC

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

LY4170156

Drug

Intravenous

Other names: sofetabart mipitecan

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 LY4170156

    Time frame: 1 Cycle (21 days)

    Number of participants with dose-limiting toxicities (DLTs)

  2. Phase 1a: To determine the RP2D or optimal dose of LY4170156 with bevacizumab

    Time frame: 1 Cycle (21 days)

    Number of participants with DLTs

  3. Phase 1a: To determine the RP2D or optimal dose of LY4170156 with carboplatin

    Time frame: 1 Cycle (21 days)

    Number of participants with DLTs

  4. Phase 1a: To determine the RP2D or optimal dose of LY4170156 with pembrolizumab

    Time frame: 1 Cycle (21 days)

    Number of participants with DLTs

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

    Time frame: Up to Approximately 48 Months or 4 Years

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

  6. 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 48 Months or 4 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 LY4170156: Minimum Plasma Concentration (Cmin)

    Time frame: First 4 Cycles (84 days)

    PK: Cmin of LY4170156

  2. To characterize the PK properties of LY4170156: Cmin with bevacizumab or carboplatin

    Time frame: First 4 Cycles (Approximately 84 days)

    PK: Cmin of LY4170156

  3. To characterize the PK properties of LY4170156: Cmin with pembrolizumab

    Time frame: First 4 Cycles (84 days)

    PK: Cmin of LY4170156

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

    Time frame: First 4 Cycles (84 days)

    PK: AUC of LY4170156

  5. To evaluate the preliminary antitumor activity of LY4170156: Overall response rate (ORR)

    Time frame: Up to Approximately 48 Months or 4 Years

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

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

    Time frame: Up to Approximately 48 Months or 4 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 LY4170156: Duration of response (DOR)

    Time frame: Up to Approximately 48 Months or 4 Years

    DOR per investigator assessed RECIST 1.1

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

    Time frame: Up to Approximately 48 Months or 4 Years

    DOR per investigator assessed RECIST 1.1

  9. To evaluate the preliminary antitumor activity of LY4170156: Time to response (TTR)

    Time frame: Up to Approximately 48 Months or 4 Years

    TTR per investigator assessed RECIST 1.1

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

    Time frame: Up to Approximately 48 Months or 4 Years

    TTR per investigator assessed RECIST 1.1

  11. To evaluate the preliminary antitumor activity of LY4170156: Progression free survival (PFS)

    Time frame: Up to Approximately 48 Months or 4 Years

    PFS per investigator assessed RECIST 1.1

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

    Time frame: Up to Approximately 48 Months or 4 Years]

    PFS per investigator assessed RECIST 1.1

  13. To evaluate the preliminary antitumor activity of LY4170156: Disease control rate (DCR)

    Time frame: Up to Approximately 48 Months or 4 Years

    DCR per investigator assessed RECIST 1.1

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

    Time frame: Up to Approximately 48 Months or 4 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 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of 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
2027
Study completion
2027
First posted
May 6, 2024
Registry last updated
Jun 18, 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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