phone (617) 481-4020
mail [email protected]
Contact
left-arrowBack to search

A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Clinicaltrials.gov ID: NCT06238479
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 280

Conditions

Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Esophageal Cancer, Pancreatic Cancer, Ovarian Cancer, Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Prostate Cancer, Renal Pelvis Cancer, Bladder Cancer

Drugs

LY4101174

Summary

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with advanced, or metastatic 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.

Detailed Description

This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or treatment history.

Locations

8 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Status

  • RECRUITING

Central Contacts

  • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • 13176154559

Study Director

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eligibility Criteria

Inclusion Criteria:

* Have one of the following solid tumor cancers:

* Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
* Cohort A2/B1/B2: urothelial carcinoma
* Cohort C1: triple negative breast cancer
* Cohort C2: non-small cell lung cancer
* Cohort C3: ovarian or fallopian tube cancer
* Cohort C4: cervical cancer
* Cohort C5: head and neck squamous cell carcinoma
* Prior Systemic Therapy Criteria:

* Cohort A1/C1-5: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
* Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
* Prior enfortumab vedotin specific requirements:

* Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
* Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
* Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
* Measurability of disease

* Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
* Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1

* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria:

* Individual with known or suspected uncontrolled CNS metastases
* Individual with uncontrolled hypercalcemia
* Individual with uncontrolled diabetes
* Individual with evidence of corneal keratopathy or history of corneal transplant
* Any serious unresolved toxicities from prior therapy
* Significant cardiovascular disease
* Current of history of intestinal obstruction in the previous 3 months
* Recent thromboembolic event or bleeding disorder
* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
* History of pneumonitis/interstitial lung disease
* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Study Plan

LY4101174 (Dose-escalation, Cohort A1)

EXPERIMENTAL

Escalating doses of LY4101174 administered intravenously (IV).

  • DRUG:

    LY4101174

    Description:

    Intravenous

LY4101174 (Dose-optimization, Cohort A2)

EXPERIMENTAL

Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.

  • DRUG:

    LY4101174

    Description:

    Intravenous

LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5))

EXPERIMENTAL

LY4101174 administered IV.

  • DRUG:

    LY4101174

    Description:

    Intravenous

Outcome Measures

Primary Outcome Measures

Phase 1a: To determine the recommended dose of LY4101174

Time Frame: First 2 Cycles (28 days)

Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174

Time Frame: First 2 Cycles (28 days)

Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR)

Time Frame: Up to Approximately 48 Months or 4 Years

Secondary Outcome Measures

To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)

Time Frame: Cycle 1 (14 Days)

To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)

Time Frame: Cycle 1 (14 Days)

To evaluate the preliminary antitumor activity of LY4101174: Overall response rate (ORR)

Time Frame: Up to Approximately 48 Months or 4 Years

To evaluate the preliminary antitumor activity of LY4101174: Duration of response (DOR)

Time Frame: Up to Approximately 48 Months or 4 Years

To evaluate the preliminary antitumor activity of LY4101174: Time to response (TTR)

Time Frame: Up to Approximately 48 Months or 4 Years

To evaluate the preliminary antitumor activity of LY4101174: Progression free survival (PFS)

Time Frame: Up to Approximately 48 Months or 4 Years

To evaluate the preliminary antitumor activity of LY4101174: Disease control rate (DCR)

Time Frame: Up to Approximately 48 Months or 4 Years

To evaluate the preliminary antitumor activity of LY4101174: Overall survival (OS)

Time Frame: Up to Approximately 48 Months or 4 Years

Timeline

  • Last Updated
    November 18, 2024
  • Start Date
    February 2, 2024
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    March 4, 2027

Similar Trials

A Randomised Controlled Trial to Evaluate the Impact of Complement Theory’s Live 1:1 Exercise ...
light-list-check RECRUITING light-blue-people 21 - 64 Years
A Dose Finding Study of Debio 4228 in Participants With Locally Advanced/Metastatic Prostate Cancer
light-list-check RECRUITING light-blue-people ≥ 18 Years
A Study of Mental Health Care in People with Cancer
light-list-check RECRUITING light-blue-people ≥ 65 Years