LY3200882 for Solid Cancers

Not currently recruiting at 26 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Cardiovascular disease, Systemic disorder, Leukemia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY3200882, to determine its safety for individuals with solid tumors, a type of cancer that forms in tissues like muscles or bones. Researchers are exploring different combinations, including LY3200882 with other drugs such as Cisplatin and Gemcitabine, to identify the most effective mix. It suits individuals diagnosed with cancer who can swallow pills and do not have major heart issues or acute leukemia. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY3200882, the drug under study for solid tumors, has been tested in various situations. In previous studies, most patients experienced some side effects. For instance, one study reported that 93.5% of participants had side effects. These effects are common in early trials and help researchers understand the drug's safety.

When combined with treatments like cisplatin, radiation, and chemotherapy drugs such as gemcitabine and nab-paclitaxel, the goal was to assess patient tolerance. These studies aim to balance effective cancer treatment with side effect management.

As this trial is in its early phase, the focus remains on identifying potential risks and assessing drug tolerance. While no definitive answers exist yet, these early studies provide a clearer idea of what to expect. Participants considering this trial should discuss any concerns with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LY3200882 because it targets solid cancers with a potentially novel approach. Unlike traditional treatments that often rely on chemotherapy or radiation alone, LY3200882 is tested in combination with other agents like Cisplatin, Gemcitabine, or nab-Paclitaxel, possibly enhancing their effectiveness. This trial also explores combinations with LY3300054, offering a chance to discover synergies that could improve patient outcomes. By investigating various schedules and combinations, LY3200882 might offer a more tailored and potentially more effective option for patients with solid tumors.

What evidence suggests that this trial's treatments could be effective for solid cancers?

Research has shown that LY3200882 may help shrink tumors in people with advanced cancer. One study demonstrated a 94% reduction in tumor size without major side effects when used alone. This trial will explore various treatment arms involving LY3200882, including combinations with other therapies such as Cisplatin and Radiation, LY3300054, and Gemcitabine with nab-Paclitaxel. LY3200882 works by affecting the area around the tumor, which typically aids cancer growth and spread. By disrupting this area, LY3200882 can help reduce tumors and possibly lead to better outcomes. Although research remains in the early stages, these initial results are promising for its potential to treat solid tumors. ^{6 7 8 9 10}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people with solid tumors who can prove their cancer diagnosis, have good organ function, and are in decent physical shape (ECOG status of 0 or 1). They must be able to take pills. It's not for those with serious heart disease, other severe illnesses, or acute leukemia.

Inclusion Criteria

My organs are functioning well.

My cancer diagnosis was confirmed through lab tests on tissue or fluid samples.

I can swallow pills.

Exclusion Criteria

I do not have serious heart problems.

I do not have acute leukemia.

I do not have a serious illness besides my current condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3200882 in combination with other treatments such as Cisplatin, Radiation, or other drugs to evaluate safety

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3200882

Trial Overview The study is testing the safety of a new drug called LY3200882 on solid tumors. Participants will also receive established cancer treatments like nab-Paclitaxel, radiotherapy, Cisplatin, LY3300054, and Gemcitabine.

How Is the Trial Designed?

Group I: LY3200882 Schedule 2 Expansion Experimental Treatment 1 Intervention

Group II: LY3200882 Schedule 2 Escalation Experimental Treatment 1 Intervention

Group III: LY3200882 Schedule 1 Expansion Experimental Treatment 1 Intervention

Group IV: LY3200882 Schedule 1 Escalation Experimental Treatment 1 Intervention

Group V: LY3200882 + LY3300054 Experimental Treatment 2 Interventions

Group VI: LY3200882 + Gemcitabine + nab-Paclitaxel Experimental Treatment 3 Interventions

Group VII: LY3200882 + Cisplatin + Radiation Experimental Treatment 3 Interventions

Group VIII: Japanese Arm LY3200882 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. researchgate.net researchgate.net/publication/354746841_First-In-Human_Phase_I_Study_of_a_Next-Generation_Oral_TGFb_Receptor_1_Inhibitor_LY3200882_in_Patients_with_Advanced_Cancer

First-In-Human Phase I Study of a Next-Generation, Oral, ... He had a 94% tumor reduction by RANO assessment on LY3200882 monotherapy at 50 mg twice a day (2w/2w schedule), with no clinical toxicities, and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0142961222001570

The programmed site-specific delivery of LY3200882 and ... The programmed site-specific delivery of LY3200882 and PD-L1 siRNA boosts immunotherapy for triple-negative breast cancer by remodeling tumor microenvironment.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061708/

Recent advances in therapeutic use of transforming growth ... ... cancer cells in several solid tumors (113). Overexpression of integrin αvβ6 ... Targeting the tumor microenvironment: from understanding pathways to effective ...

4. frontiersin.org frontiersin.org/journals/cell-and-developmental-biology/articles/10.3389/fcell.2020.00605/full

On-Target Anti-TGF-β Therapies Are Not Succeeding in ... Metastasis is the leading cause of death for cancer patients. During cancer progression, the initial detachment of cells from the primary tumor and the ...

5. explorationpub.com explorationpub.com/Journals/etat/Article/1002137

signaling: from tumor microenvironment to anticancer therapy ISTH0047 elevates the expression of CD86 in TAMs and inhibits lung metastasis in syngeneic orthotopic renal cell carcinoma and breast cancer tumor models by ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02937272

A Study of LY3200882 in Participants 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.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34548321/

First-In-Human Phase I Study of a Next-Generation, Oral ... In treatment-naïve patients with advanced pancreatic cancer, 6 of 12 patients achieved Response Evaluation Criteria in Solid Tumors (RECIST) v1.

8. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-21-1504/673955/am/First-In-Human-Phase-I-Study-of-a-Next-Generation

First-In-Human Phase I Study of a Next-Generation, Oral ... ... cancer (LY3200882, cisplatin and radiation). Results: Overall, 139 patients with advanced cancer were treated. Majority (93.5%) of patients experienced ...

9. clinicaltrial.be clinicaltrial.be/en/details/9698?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

A Study of LY3200882 in Participants 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. Trial design.

10. trials.lilly.com trials.lilly.com/en-US/trial/118969

A Study of LY3200882 in Participants 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.