A Study of LY3435151 in Participants With Solid Tumors

NCT ID: NCT04099277

Last Updated: 2021-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2020-03-05

Brief Summary

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The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.

Detailed Description

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Conditions

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Solid Tumor Triple-negative Breast Cancer Gastric Adenocarcinoma Head and Neck Squamous Cell Carcinoma Cervical Carcinoma High Grade Serous Ovarian Carcinoma Hepatocellular Carcinoma Undifferentiated Pleomorphic Sarcoma Leiomyosarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: 10 milligrams (mg) LY3435151

Participants received intravenous (IV) push or IV bolus infusion of 10 mg LY3435151.

Group Type EXPERIMENTAL

LY3435151

Intervention Type DRUG

Administered IV

Part B: LY3435151 + Pembrolizumab Dose Escalation

Pembrolizumab was not administered as study was terminated before completion of Part A of the dose escalation period.

Group Type EXPERIMENTAL

LY3435151

Intervention Type DRUG

Administered IV

Pembrolizumab

Intervention Type DRUG

Administered IV

Part C: LY3435151 Dose Expansion

Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase.

Group Type EXPERIMENTAL

LY3435151

Intervention Type DRUG

Administered IV

Part D: LY3435151 + Pembrolizumab Dose Expansion

Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase.

Group Type EXPERIMENTAL

LY3435151

Intervention Type DRUG

Administered IV

Pembrolizumab

Intervention Type DRUG

Administered IV

Interventions

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LY3435151

Administered IV

Intervention Type DRUG

Pembrolizumab

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must have certain types of cancer, which your study doctor will discuss with you
* Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
* Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
* Participant must agree to use birth control
* Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you

Exclusion Criteria

* Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
* Participant must not have an autoimmune disease, which your study doctor will discuss with you
* Participant must not use corticosteroids, which your study doctor will discuss with you
* Participant must not have heart disease, Crohn's disease or brain cancer
* Participant must not be pregnant or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

National Cancer Center Hospital

Chuo-Ku, Tokyo, Japan

Site Status

Countries

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United States Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.lillytrialguide.com/en-US/studies/solid-tumor/JZIA#?postal=

A Study of LY3435151 in Participants With Solid Tumors

Other Identifiers

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J1Q-MC-JZIA

Identifier Type: OTHER

Identifier Source: secondary_id

17364

Identifier Type: -

Identifier Source: org_study_id

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