NCT02937272

Brief Summary

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

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for phase_1

Timeline
3mo left

Started Nov 2016

Longer than P75 for phase_1

Geographic Reach
8 countries

18 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Nov 2016Aug 2026

First Submitted

Initial submission to the registry

October 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 21, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2020

Completed
6.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3.3 years

First QC Date

October 17, 2016

Last Update Submit

October 17, 2025

Conditions

Solid Tumor

Keywords

TGF Beta

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

    Cycle 1 (28 days)

  • Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)

    Baseline through Disease Progression or Death (estimated at up to 12 months)

Secondary Outcomes (6)

  • Pharmacokinetics (PK): Area Under the Curve (AUC) (AUC[0-24]) at Steady State of LY3200882

    Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)

  • PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882

    Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)

  • ORR: Percentage of Participants with CR or PR

    Baseline through Disease Progression or Death (estimated at up to 12 months)

  • Overall Survival (OS)

    Baseline to Date of Death from Any Cause (estimated at up to 12 months)

  • Duration of Response (DoR)

    Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (estimated at up to 12 months)

  • +1 more secondary outcomes

Study Arms (8)

LY3200882 Schedule 1 Escalation

EXPERIMENTAL
Drug: LY3200882

LY3200882 Schedule 2 Escalation

EXPERIMENTAL
Drug: LY3200882

LY3200882 Schedule 1 Expansion

EXPERIMENTAL
Drug: LY3200882

LY3200882 Schedule 2 Expansion

EXPERIMENTAL
Drug: LY3200882

LY3200882 + LY3300054

EXPERIMENTAL
Drug: LY3200882Drug: LY3300054

LY3200882 + Gemcitabine + nab-Paclitaxel

EXPERIMENTAL
Drug: LY3200882Drug: GemcitabineDrug: nab-Paclitaxel

LY3200882 + Cisplatin + Radiation

EXPERIMENTAL
Drug: LY3200882Drug: CisplatinRadiation: Intensity Modulated Radiotherapy

Japanese Arm LY3200882

EXPERIMENTAL
Drug: LY3200882

Interventions

LY3200882DRUG

Administered orally

Japanese Arm LY3200882LY3200882 + Cisplatin + RadiationLY3200882 + Gemcitabine + nab-PaclitaxelLY3200882 + LY3300054LY3200882 Schedule 1 EscalationLY3200882 Schedule 1 ExpansionLY3200882 Schedule 2 EscalationLY3200882 Schedule 2 Expansion
LY3300054DRUG

Administered intravenously

LY3200882 + LY3300054
GemcitabineDRUG

Administered intravenously

LY3200882 + Gemcitabine + nab-Paclitaxel
nab-PaclitaxelDRUG

Administered intravenously

LY3200882 + Gemcitabine + nab-Paclitaxel
CisplatinDRUG

Administered intravenously

LY3200882 + Cisplatin + Radiation
Intensity Modulated RadiotherapyRADIATION
LY3200882 + Cisplatin + Radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Calvary Mater Newcastle

Newcastle, New South Wales, 2298, Australia

Location

St Vincent's Hospital Sydney

Sydney, New South Wales, 2010, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Princess Margaret Hospital (Ontario)

Lai Chi Kok, Kowloon, Canada

Location

Hopital Saint-Louis

Paris, Cedex 10, 75475, France

Location

CHRU de Lille

Lille, 59037, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Würzburg A. ö. R.

Würzburg, Bavaria, 97080, Germany

Location

Charité Campus Virchow-Klinikum

Berlin, 12203, Germany

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Ospedale Policlinico Giambattista Rossi, Borgo Roma

Verona, 37134, Italy

Location

National Cancer Center Hospital

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • Yap TA, Vieito M, Baldini C, Sepulveda-Sanchez JM, Kondo S, Simonelli M, Cosman R, van der Westhuizen A, Atkinson V, Carpentier AF, Lohr M, Redman R, Mason W, Cervantes A, Le Rhun E, Ochsenreither S, Warren L, Zhao Y, Callies S, Estrem ST, Man M, Gandhi L, Avsar E, Melisi D. First-In-Human Phase I Study of a Next-Generation, Oral, TGFbeta Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer. Clin Cancer Res. 2021 Dec 15;27(24):6666-6676. doi: 10.1158/1078-0432.CCR-21-1504. Epub 2021 Sep 21.

    PMID: 34548321DERIVED

Related Links

MeSH Terms

Conditions

Camurati-Engelmann Syndrome

Interventions

LY3300054Gemcitabine130-nm albumin-bound paclitaxelCisplatinRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 18, 2016

Study Start

November 21, 2016

Primary Completion

February 27, 2020

Study Completion (Estimated)

August 1, 2026

Last Updated

October 20, 2025

Record last verified: 2025-10

Locations

FR(3)CA(1)AU(3)US(3)DE(2)IT(2)ES(3)JP(1)