Xentuzumab + Abemaciclib for Breast Cancer

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of: * Xentuzumab in combination with abemaciclib * Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer. Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib. For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

Research Team

Boehringer Ingelheim

Principal Investigator

Boehringer Ingelheim

Eligibility Criteria

Adults with stage IV NSCLC or breast cancer who have tried certain treatments without success can join. They must be able to swallow pills, have no other cancers in the last 3 years, and not need drugs that could interfere with the trial. Women must not be pregnant and use birth control; men also need to use effective contraception.

Inclusion Criteria

My cancer can be measured by scans or is only in my bones without spreading to soft tissues.

You have experienced a relapse with specific evidence of progression according to the described timeline, and have received limited prior treatments for advanced/metastatic disease. For cohort D1, you must have a documented visceral metastasis, while for cohort D2, you must not have any visceral metastasis.

You have a disease that can be measured according to specific guidelines.

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Exclusion Criteria

Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study subject or unlikely to complete the trial

Currently enrolled in another investigational device or drug study, or less than 21 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s)

I have a known kidney condition such as glomerulonephritis or Fanconi Syndrome.

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Treatment Details

Interventions

Abemaciclib (Cyclin-dependent kinase (CDK) inhibitor)
Anastrozole (Hormone Therapy)
Fulvestrant (Hormone Therapy)
Letrozole (Hormone Therapy)
Xentuzumab (Monoclonal Antibodies)

Trial OverviewThe study is testing Xentuzumab combined with Abemaciclib, plus hormonal therapies for some breast cancer patients. It aims to find a safe dosage while checking if these medicines shrink tumors. Participants will receive regular health checks and tumor size assessments.

Participant Groups

8Treatment groups

Experimental Treatment

Group I: Cohort FExperimental Treatment3 Interventions

Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Group II: Cohort EExperimental Treatment2 Interventions

Xentuzumab + Abemaciclib (Dose 1)

Group III: Cohort D2Experimental Treatment3 Interventions

Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Group IV: Cohort D1Experimental Treatment3 Interventions

Xentuzumab + Abemaciclib + Fulvestrant (Dose 4)

Group V: Cohort DExperimental Treatment3 Interventions