A Study of LY3200882 in Participants With Solid Tumors

March 30, 2026 updated by: Eli Lilly and Company

A Phase 1 Study of LY3200882 in Patients With Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
223

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Greenslopes Private Hospital
  • Canada
    • Kowloon
      • Lai Chi Kok, Kowloon, Canada
        • Princess Margaret Hospital (Ontario)
  • France
      • Lille, France, 59037
        • CHRU de Lille
      • Villejuif, France, 94805
        • Gustave Roussy
    • Cedex 10
      • Paris, Cedex 10, France, 75475
        • Hôpital Saint-Louis
  • Germany
      • Berlin, Germany, 12203
        • Charité Campus Virchow-Klinikum
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Universitätsklinikum Würzburg A. ö. R.
  • Italy
      • Verona, Italy, 37134
        • Ospedale Policlinico Giambattista Rossi, Borgo Roma
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
  • Japan
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participant must have histological or cytological evidence of cancer.
  • Have adequate organ function.
  • Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.
  • Are able to swallow capsules and tablets.

Exclusion Criteria:

  • Have moderate or severe cardiovascular disease.
  • Have a serious concomitant systemic disorder.
  • Have acute leukemia.

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LY3200882 Schedule 1 Escalation
Drug: LY3200882
Administered orally
Experimental: LY3200882 Schedule 2 Escalation
Drug: LY3200882
Administered orally
Experimental: LY3200882 Schedule 1 Expansion
Drug: LY3200882
Administered orally
Experimental: LY3200882 Schedule 2 Expansion
Drug: LY3200882
Administered orally
Experimental: LY3200882 + LY3300054
Drug: LY3200882
Administered orally
Drug: LY3300054
Administered intravenously
Experimental: LY3200882 + Gemcitabine + nab-Paclitaxel
Drug: nab-Paclitaxel
Administered intravenously
Drug: Gemcitabine
Administered intravenously
Drug: LY3200882
Administered orally
Experimental: LY3200882 + Cisplatin + Radiation
Drug: Cisplatin
Administered intravenously
Drug: LY3200882
Administered orally
Radiation: Intensity Modulated Radiotherapy
Experimental: Japanese Arm LY3200882
Drug: LY3200882
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time Frame: Cycle 1 (28 days)
Cycle 1 (28 days)
Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months)
Baseline through Disease Progression or Death (estimated at up to 12 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882
Time Frame: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
ORR: Percentage of Participants with CR or PR
Time Frame: Baseline through Disease Progression or Death (estimated at up to 12 months)
Baseline through Disease Progression or Death (estimated at up to 12 months)
Overall Survival (OS)
Time Frame: Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Duration of Response (DoR)
Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)
Progression-Free Survival (PFS)
Time Frame: Baseline to Disease Progression or Death (estimated at up to 12 months)
Baseline to Disease Progression or Death (estimated at up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16185
  • I8X-MC-JECA (Other Identifier: Eli Lilly and Company)
  • 2016-001431-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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