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Chemotherapy

CA-4948 + Chemotherapy/Immunotherapy for Stomach & Esophageal Cancer

Phase 1

Recruiting

Led By Patrick Grierson, M.D., Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

Normal bone marrow and organ function criteria

Must not have

Active, known, or suspected autoimmune disease

Live attenuated vaccine within 30 days prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to evaluate the combination of CA-4948 and standard chemo/immunotherapy in untreated gastric and esophageal cancer.

Who is the study for?

Adults with advanced, inoperable or metastatic stomach, gastroesophageal junction, or esophageal cancer. They must not have had previous systemic treatment for their cancer and should be in good physical condition (ECOG 0-1). Participants need normal organ and bone marrow function and known HER2 status. Women of childbearing potential and men must agree to use contraception.

What is being tested?

The trial is testing CA-4948 combined with FOLFOX chemotherapy and a PD-1 inhibitor (nivolumab or pembrolizumab), with an additional option of trastuzumab for those with HER2 positive disease. It includes dose escalation to find the safest dose followed by expansion cohorts based on HER2 status.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, fatigue, digestive issues like nausea or diarrhea, blood cell count changes which can affect immunity and healing capacity.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My bone marrow and organs are functioning normally.

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I haven't had systemic treatment for my advanced stomach or esophagus cancer.

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My cancer is in the stomach, gastroesophageal junction, or esophagus and cannot be surgically removed.

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I am fully active or can carry out light work.

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My cancer is HER2 negative.

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My adenocarcinoma's HER2 status is known from a certified lab test.

Exclusion Criteria

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

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I have an autoimmune disease.

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I have not received a live vaccine in the last 30 days.

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I have a stomach or intestine condition that affects how my body absorbs medication.

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I have brain metastases that are treated and I have no symptoms.

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I am not taking any medications that can cause long QT syndrome.

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I have had an organ or stem cell transplant from a donor.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I do not have any uncontrolled illnesses.

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I have a lung condition that is moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Disease control rate (DCR)

Overall response rate (ORR) per RECIST 1.1

Overall response rate (ORR) per iRECIST

+3 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 B (CA4948 + FOLFOX + Pembrolizumab + Trastuzumab)Experimental Treatment4 Interventions

* CA4948 (dose will be the recommended dose found in the dose escalation portion of study) twice daily by mouth Standard of care mFOLFOX7 every 14 days. Pembrolizumab on day 1 of every 3 cycles. Trastuzumab every 14 days. * Each cycle is 14 days.

Group II: Dose Expansion Cohort A (CA4948 + FOLFOX + Nivolumab)Experimental Treatment3 Interventions

* CA4948 (dose will be the recommended phase II dose found in the dose escalation portion of study) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days.

Group III: Dose Escalation (CA4948 + FOLFOX + Nivolumab)Experimental Treatment3 Interventions

* CA4948 (dose will depend on dose level assigned) twice daily by mouth. Standard of care mFOLFOX7 every 14 days. Nivolumab every 14 days. * Each cycle is 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

mFOLFOX7

2018

Completed Phase 2

~130