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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Expansion dose of CA-4948 in combination with FOLFOX/PD-1 inhibitor with/without trastuzumab
Safety of regimen as measured by number of adverse events
Secondary outcome measures
Disease control rate (DCR)
Overall response rate (ORR) per RECIST 1.1
Overall response rate (ORR) per iRECIST
+3 moreTrial 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
Pembrolizumab
2017
Completed Phase 2
~2010
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,739 Total Patients Enrolled
Curis, Inc.Industry Sponsor
16 Previous Clinical Trials
1,072 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,648 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on any experimental drugs, or it has been 7 days since my last dose.I have an autoimmune disease.I had palliative radiation therapy over 10 days ago.I have not received a live vaccine in the last 30 days.I am 18 years old or older.My bone marrow and organs are functioning normally.I have had up to two rounds of FOLFOX chemotherapy.I had chemoradiation treatment more than 3 months ago.I have a stomach or intestine condition that affects how my body absorbs medication.I had chemo or other systemic therapy with surgery over a year ago.I am using or plan to use alternative cancer treatments.I have brain metastases that are treated and I have no symptoms.My cancer can be biopsied for research, or an exception has been made.I am not taking any medications that can cause long QT syndrome.I am enrolled based on my cancer being HER2 positive or negative.I have had an organ or stem cell transplant from a donor.I haven't taken steroids or immunosuppressants in the last 14 days.I haven't had systemic treatment for my advanced stomach or esophagus cancer.I am willing to follow the lifestyle guidance in the study.I haven't had any cancer besides a slow-growing one in the past 2 years.My cancer is in the stomach, gastroesophageal junction, or esophagus and cannot be surgically removed.I am fully active or can carry out light work.I do not have any uncontrolled illnesses.My cancer is HER2 negative.I have a lung condition that is moderate to severe.My adenocarcinoma's HER2 status is known from a certified lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Cohort B (CA4948 + FOLFOX + Pembrolizumab + Trastuzumab)
- Group 2: Dose Escalation (CA4948 + FOLFOX + Nivolumab)
- Group 3: Dose Expansion Cohort A (CA4948 + FOLFOX + Nivolumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the regulatory body granted permission to administer CA-4948?
"CA-4948 holds a score of 1 due to its status as a Phase 1 trial, which indicates limited data on both the safety and efficacy of the medication."
Answered by AI
Are there any available enrolment opportunities in this experiment?
"As reflected on clinicaltrials.gov, this trial is no longer recruiting patients; the initial posting was made on November 30th 2022 and it has not been updated since September 15th of the same year. Fortunately, 893 other medical studies are actively searching for volunteers right now."
Answered by AI
What objectives is this investigation striving to realize?
"As reported by Curis, Inc., the principal assessment for this clinical trial over a 19-month timespan is safety as determined through adverse events. Secondary outcomes evaluated will encompass Progression-free rate (PFR), Disease control rate (DCR) and Overall response rate (ORR). These are respectively defined as proportion of participants with no disease progression, complete or partial responses to treatment according to RECIST 1.1 criteria, and number of patients with complete or partial response per RECIST 1.1 guidelines."
Answered by AI
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