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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-05

Primary completion: 2026-08-26

Study completion finish: 2027-03-04

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06238479

Intervention or treatment

DRUG: LY4101174

Conditions

• Metastatic Solid Tumor
• Recurrent Solid Tumor
• Advanced Solid Tumor
• 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
• Bladder Cancer
• Urinary Bladder Neoplasm
• Renal Pelvis Cancer

Condition: Metastatic Solid Tumor, Recurrent Solid Tumor and more
DRUG: LY4101174
Heidelberg, Victoria, Australia and more
Sponsor: Eli Lilly and Company

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Austin Health

Research sites nearby

Select from list below to view details:

Austin Health
Heidelberg, Victoria, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: LY4101174 (Dose-escalation, Cohort A1) Escalating doses of LY4101174 administered intravenously (IV).	DRUG: LY4101174 Intravenous
EXPERIMENTAL: LY4101174 (Dose-optimization, Cohort A2) Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV.	DRUG: LY4101174 Intravenous
EXPERIMENTAL: LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5)) LY4101174 administered IV.	DRUG: LY4101174 Intravenous

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 1a: To determine the recommended dose of LY4101174	Number of participants with dose-limiting toxicities (DLTs)	First 2 Cycles (28 days)
Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174	Number of participants with DLTs	First 2 Cycles (28 days)
Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)	PK: Cmin of LY4101174	Cycle 1 (14 Days)
To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)	PK: AUC of LY4101174	Cycle 1 (14 Days)
To evaluate the preliminary antitumor activity of LY4101174: Overall response rate (ORR)	ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Duration of response (DOR)	DOR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Time to response (TTR)	TTR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Progression free survival (PFS)	PFS per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Disease control rate (DCR)	DCR per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Overall survival (OS)	OS per investigator assessed RECIST 1.1	Up to Approximately 48 Months or 4 Years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors