LY4170156 for Breast Cancer

Recruiting at 37 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: CNS metastases, Carcinomatous meningitis, Infections, others

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

Compensation: Varies

Number of Visits: 4

495 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, LY4170156 (also known as MBK-103), to determine its safety and effectiveness for individuals with advanced solid tumors. The trial consists of two parts: one to identify the appropriate dose and another to explore different dose effects, including combinations with other drugs. Participants with conditions such as ovarian cancer, endometrial cancer, or triple-negative breast cancer may qualify, particularly if they have had these cancers for some time. The trial involves receiving the treatment through an IV and may last up to four years. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 LY4170156 is likely to be safe for humans?

Research shows that LY4170156 looks promising in early studies. Initial trial results indicate that patients generally tolerate LY4170156 well. Those who received the treatment experienced manageable side effects, and there was encouraging activity against certain tumors.

Regarding safety, combining LY4170156 with other drugs, such as bevacizumab or carboplatin, also appears safe based on previous studies. Bevacizumab has been used in cancer treatments before and is generally safe when combined with other drugs. Similarly, carboplatin is a common cancer treatment with a known safety record.

Since this trial is in its early stages (Phase 1), the main goal is to find the safest dose. The drug is still being tested, and more data will help researchers better understand its safety. Overall, the findings so far are positive, but as with any new treatment, ongoing trials will provide more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Unlike the standard treatments for breast cancer, which often include hormone therapies like tamoxifen, chemotherapy drugs such as doxorubicin, and targeted therapies like trastuzumab, LY4170156 offers a novel approach with its unique features. This investigational drug is being tested in several different ways, including as a monotherapy and in combination with other cancer treatments like bevacizumab and carboplatin. What sets LY4170156 apart is its potential to work at varying doses, offering flexibility and the potential for optimization based on patient response. Researchers are particularly excited about its intravenous administration, which may allow for more controlled delivery and potentially improved efficacy over oral medications. These factors make LY4170156 a promising new hope in the fight against breast cancer.

What evidence suggests that LY4170156 might be an effective treatment for breast cancer?

Research suggests that LY4170156 might help treat advanced solid tumors, including breast cancer, by targeting the folate receptor alpha, a protein important in cancer therapy. Early studies have shown that LY4170156 is well-tolerated, with some patients demonstrating promising responses. In this trial, participants may receive LY4170156 alone, as some patients with ovarian cancer similar to certain breast cancers responded well to monotherapy. Alternatively, participants might receive LY4170156 with bevacizumab, a drug that prevents tumors from growing new blood vessels and has shown encouraging results. Another option in this trial is the combination of LY4170156 with carboplatin, a chemotherapy drug, which may improve outcomes in cancers similar to breast cancer. These findings offer hope for its potential effectiveness in breast cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 individuals with advanced solid tumors, including pancreatic, cervical, breast, colorectal cancer, endometrial cancer, non-small cell lung cancer and ovarian tumors. Specific eligibility criteria are not provided.

Inclusion Criteria

I have a specific type of cancer such as ovarian, endometrial, cervical, lung, breast, pancreatic, or colorectal.

Exclusion Criteria

I have had cancer spread to the lining of my brain and spinal cord.

I do not have any active, uncontrolled infections.

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose-escalation

Escalating doses of LY4170156 administered intravenously to determine the recommended phase 2 dose (RP2D)

12 weeks

4 cycles of 21 days each

Phase 1b: Dose-expansion

LY4170156 administered intravenously to assess antitumor activity

Up to 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4170156

Trial Overview The study tests LY4170156's safety and effectiveness in treating various advanced cancers. It has two parts: phase Ia to find the right dose and phase Ib to see how well it works at that dose over approximately four years.

How Is the Trial Designed?

Group I: LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6) Experimental Treatment 2 Interventions

Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab

Group II: LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B) Experimental Treatment 2 Interventions

LY4170156 administered IV and itraconazole administered orally

Group III: LY4170156 (Enrichment Cohort A3) Experimental Treatment 1 Intervention

Monotherapy administered IV

Group IV: LY4170156 (Dose-optimization, Cohort A2) Experimental Treatment 1 Intervention

Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV

Group V: LY4170156 (Dose-expansion, Cohort B1-B4) Experimental Treatment 1 Intervention

LY4170156 administered IV

Group VI: LY4170156 (Dose-escalation, Cohort A1) Experimental Treatment 1 Intervention

Escalating doses of LY4170156 administered intravenously (IV)

Group VII: LY4170156 (Combination Cohort A5) Experimental Treatment 2 Interventions

Combination with carboplatin administered IV

Group VIII: LY4170156 (Combination Cohort A4) Experimental Treatment 2 Interventions

Combination with bevacizumab administered IV

Group IX: LY4170156 (Cohort A1 Parts A and C) Experimental Treatment 1 Intervention

LY4170156 administered IV

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

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06400472

NCT06400472 | A Study of LY4170156 in Participants With ... The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3023

Initial results from a first-in-human phase 1 study of ... Conclusions: LY4170156 was well-tolerated with encouraging clinical activity among HGSOC pts, including those with FRα expression < 75% and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07213804

NCT07213804 | A Two-Part Phase 3 Study of LY4170156 ... This is a clinical study that has two parts. It is testing a potential new medicine called LY4170156 for people with certain types of ovarian, peritoneal, ...

4. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/breast-cancer

UCSD Breast Cancer Clinical Trials for 2025 — San Diego The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid ...

5. healthscout.app healthscout.app/trial_match/view_trial/NCT06400472/

Trial: A Study of LY4170156 in Participants Wi… - HealthScout A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)03674-3/fulltext

795TiP A first-in-human phase I study of LY4170156, an ... Primary objectives are to determine the RP2D and assess the safety of LY4170156. Key secondary objectives are to evaluate the pharmacokinetic profile and ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/482318

A Study of LY4170156 in Participants With Selected ... The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors.

8. firstwordpharma.com firstwordpharma.com/story/6320946

Lilly to present new clinical data for Verzenio (abemaciclib ... In a poster presentation, Lilly will share updated safety and efficacy results from the Phase 1a/1b study of LY4170156 in patients with platinum ...