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Kinase Inhibitor

Trastuzumab Deruxtecan + Azenosertib for Stomach Cancer

Phase 1

Recruiting

Led By Funda Meric-Bernstam

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

T-DXd (DS-8201a)-naIve disease

CCNE1 amplification,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new combination treatment of azenosertib and trastuzumab deruxtecan for patients with HER2-positive cancers. Azenosertib targets a protein

Who is the study for?

This trial is for adults with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer, as well as other HER2-positive solid tumors that are advanced, metastatic, or unresectable. Participants must have recovered from previous therapy side effects and have an adequate performance status.

What is being tested?

The trial tests the safety and optimal dose of azenosertib combined with trastuzumab deruxtecan in treating certain cancers. Azenosertib inhibits Wee1 protein to enhance tumor cell vulnerability, while trastuzumab deruxtecan targets and kills HER2 positive cancer cells.

What are the potential side effects?

Both azenosertib and trastuzumab deruxtecan can cause fatigue among other side effects. The combination treatment aims to be safe but may also lead to additional risks which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I have never been treated with T-DXd (DS-8201a).

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My cancer has CCNE1 amplification.

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I have never been treated with T-DXd (DS-8201a).

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My cancer shows HER2 presence through specific tests.

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My cancer shows some level of HER2 protein or has more HER2 genes.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (AEs)

Incidence of dose limiting toxicities (DLTs)

Maximum tolerated dose

Secondary study objectives

Duration of response

Objective response rate (ORR)

Pharmacodynamic effects in the tumor

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Dose expansion, Cohort 2 (T-DXd, azenosertib)Experimental Treatment7 Interventions

Patients receive treatment as in the dose escalation arm. Patients also undergo ECHO or MUGA and collection of blood samples at screening and on study and undergo CT or MRI throughout the trial. Patients also undergo biopsy at screening and on study.

Group II: Dose expansion, Cohort 1 (T-DXd, azenosertib)Experimental Treatment8 Interventions

Patients receive T-DXd IV over 30-90 minutes on day 1 of each cycle and azenosertib PO QD on days 8-12 and 15-19 of cycle 1 and days 1-5, 8-12, and 15-19 in subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA and collection of blood samples at screening and on study and undergo CT or MRI throughout the trial. Patients also undergo biopsy at screening and on study.

Group III: Dose escalation (T-DXd, azenosertib)Experimental Treatment7 Interventions

Patients receive T-DXd IV over 30-90 minutes on day 1 of each cycle and azenosertib PO QD on days 1-5, 8-12, and 15-19 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA and collection of blood samples at screening and on study and undergo CT or MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab Deruxtecan

2021

Completed Phase 2

~100

Biopsy

2014

Completed Phase 4

~1090