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MDM2/MDMX Inhibitor

ALRN-6924 + Paclitaxel for Advanced Cancers

Phase 1

Waitlist Available

Led By Ecaterina E Dumbrava

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No major surgery within 1 month of treatment and fully recovered

Estrogen receptor (ER) positive (> 1%), human epidermal growth factor 2 (HER2) negative, WT TP53 metastatic or inoperable locally advanced or locally recurrent breast cancer regardless of progesterone receptor (PR) status

Must not have

Patients with a known Human Papilloma Virus (HPV)-positive malignancy

Females who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of ALRN-6924 when given with paclitaxel to treat patients with solid tumors.

Who is the study for?

This trial is for adults with advanced or inoperable solid tumors, including a specific type of breast cancer (ER positive, HER2 negative) with WT TP53. Participants must not have had another cancer within the last 2 years and should have no major health issues that could affect study participation. They need to use effective contraception and cannot be pregnant or nursing.

What is being tested?

The trial is testing the combination of ALRN-6924, an experimental drug, with paclitaxel, a chemotherapy medication. It aims to find the safest dose and observe how well this combo works against metastatic or unresectable solid tumors by stopping their growth or spread.

What are the potential side effects?

Possible side effects include reactions related to chemotherapy such as fatigue, hair loss, nausea, neuropathy (nerve pain), and increased risk of infection. ALRN-6924 may also cause additional side effects which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had major surgery in the last month and have fully recovered.

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My breast cancer is ER positive, HER2 negative, and cannot be removed by surgery.

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My cancer is confirmed by lab tests, has spread, and cannot be surgically removed.

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I haven't had any other cancer in the last 2 years.

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, with specific genetic changes.

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My organs are functioning well.

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I am 18 years old or older.

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My TP53 gene does not have mutations, confirmed by a specific test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is HPV-positive.

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I am not pregnant or nursing.

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I have symptoms from cancer spread to my brain.

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I have been treated with drugs targeting MDM2 or MDMX before.

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I have moderate to severe nerve damage.

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I have hepatitis B, C, or HIV with a CD4 count below 200.

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I have heart rhythm problems that are not well-controlled.

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I have a history of heart problems or am at risk for them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Clinical benefit rate

Duration of response (DoR)

Objective response rate (ORR) defined as the proportion of patients with complete response (CR) or partial response (PR), as determined by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)

+2 more

Other study objectives

Cell proliferation and apoptosis assays

Cell-free deoxyribonucleic acid (DNA)

Gene expression profiling

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (paclitaxel, ALRN-6924)Experimental Treatment2 Interventions

Patients receive paclitaxel IV over 1 hour and MDM2/MDMX inhibitor ALRN-6924 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

0 / 17Eligibility criteria met