Solid TumorPhase 1NCT02937272
A Study of LY3200882 in Participants With Solid Tumors
A Phase 1 study testing LY3200882, LY3300054 and Gemcitabine in people with Solid Tumor, run by Eli Lilly and Company at 18 sites in 8 countries.
Trial summary
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- LY3200882, LY3300054 and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 18 sitesin 8 countries
- Study dates
- 21 Nov 2016to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Have moderate or severe cardiovascular disease.
- Have a serious concomitant systemic disorder.
- Have acute leukemia.
Trial locations and contacts
18 sites in 8 countries.
18 sites in 8 countries
United States3 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
Weill Cornell Medical College
New York, New York, 10021
Australia3 sites
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Calvary Mater Newcastle
Newcastle, New South Wales, 2298
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
France3 sites
CHRU de Lille
Lille, 59037
Hopital Saint-Louis
Paris, Cedex 10, 75475
Gustave Roussy
Villejuif, 94805
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Clínico Universitario de Valencia
Valencia, 46010
Germany2 sites
Charité Campus Virchow-Klinikum
Berlin, 12203
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, 97080
Italy2 sites
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, 37134
About this study
Official title: 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.
- Conditions
- Solid Tumor
- Being tested
- LY3200882, LY3300054, Gemcitabine, nab-Paclitaxel, Cisplatin
- Keywords
- TGF Beta
- Medical subject headings
- Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3200882Drug
Administered orally
LY3300054Drug
Administered intravenously
GemcitabineDrug
Administered intravenously
nab-PaclitaxelDrug
Administered intravenously
CisplatinDrug
Administered intravenously
Intensity Modulated RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| LY3200882 Schedule 1 Escalation | Experimental | Not described Receives: Drug: LY3200882 |
| LY3200882 Schedule 2 Escalation | Experimental | Not described Receives: Drug: LY3200882 |
| LY3200882 Schedule 1 Expansion | Experimental | Not described Receives: Drug: LY3200882 |
| LY3200882 Schedule 2 Expansion | Experimental | Not described Receives: Drug: LY3200882 |
| LY3200882 + LY3300054 | Experimental | Not described Receives: Drug: LY3200882; Drug: LY3300054 |
| LY3200882 + Gemcitabine + nab-Paclitaxel | Experimental | Not described Receives: Drug: LY3200882; Drug: Gemcitabine; Drug: nab-Paclitaxel |
| LY3200882 + Cisplatin + Radiation | Experimental | Not described Receives: Drug: LY3200882; Drug: Cisplatin; Radiation: Intensity Modulated Radiotherapy |
| Japanese Arm LY3200882 | Experimental | Not described Receives: Drug: LY3200882 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Measured: Cycle 1 (28 days)
Part B: Overall Response Rate (ORR): Percentage of Participants with Complete Response (CR) or Partial Response (PR)
Measured: 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
Measured: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
PK: AUC Zero to Infinity (AUC[0-∞]) at Steady State of LY3200882
Measured: Cycle 1 Day 1 through Cycle 2 Day 14 (28 day cycles)
ORR: Percentage of Participants with CR or PR
Measured: Baseline through Disease Progression or Death (estimated at up to 12 months)
Overall Survival (OS)
Measured: Baseline to Date of Death from Any Cause (estimated at up to 12 months)
Duration of Response (DoR)
Measured: 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)
Measured: Baseline to Disease Progression or Death (estimated at up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start21 Nov 2016
- Primary completion27 Feb 2020
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937272
- Sponsor's protocol ID
- 16185
- Other IDs
- I8X-MC-JECA, 2016-001431-12, 2016
- Status last verified
- Mar 2026
- First submitted
- 17 Oct 2016
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34548321
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LY3200882 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02937272
- Acronym / sponsor ID
- 16185
- Conditions
- Solid Tumor
- Keywords
- TGF Beta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 223 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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: LY3200882, Drug: LY3300054 |
| LY3200882 + Gemcitabine + nab-Paclitaxel | Experimental | Drug: LY3200882, Drug: Gemcitabine, Drug: nab-Paclitaxel |
| LY3200882 + Cisplatin + Radiation | Experimental | Drug: LY3200882, Drug: Cisplatin, Radiation: Intensity Modulated Radiotherapy |
| Japanese Arm LY3200882 | Experimental | Drug: LY3200882 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Have moderate or severe cardiovascular disease.
- Have a serious concomitant systemic disorder.
- Have acute leukemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3200882Administered orally | Drug | Japanese Arm LY3200882, LY3200882 + Cisplatin + Radiation, LY3200882 + Gemcitabine + nab-Paclitaxel, LY3200882 + LY3300054, LY3200882 Schedule 1 Escalation, LY3200882 Schedule 1 Expansion, LY3200882 Schedule 2 Escalation, LY3200882 Schedule 2 Expansion |
| LY3300054Administered intravenously | Drug | LY3200882 + LY3300054 |
| GemcitabineAdministered intravenously | Drug | LY3200882 + Gemcitabine + nab-Paclitaxel |
| nab-PaclitaxelAdministered intravenously | Drug | LY3200882 + Gemcitabine + nab-Paclitaxel |
| CisplatinAdministered intravenously | Drug | LY3200882 + Cisplatin + Radiation |
| Intensity Modulated Radiotherapy | Radiation | LY3200882 + Cisplatin + Radiation |
Primary outcome
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: 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)
6 secondary outcomes
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)
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)
ORR: Percentage of Participants with CR or PR
Time frame: 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)
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)
Progression-Free Survival (PFS)
Time frame: Baseline to Disease Progression or Death (estimated at up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 34548321Yap 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.
- Click here for more information about this study: A Study of LY3200882 in Participants With Solid TumorsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
18 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3200882, LY3300054 and Gemcitabine in people with Solid Tumor, run by Eli Lilly and Company at 18 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia, France, Spain, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.