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Chemotherapy

APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days for Rectal Cancer

Phase 2
Waitlist Available
Led By Todd Aguilera, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Group (ECOG) performance status of 0-1.
Pathologic diagnosis of rectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing if a new cancer drug can help patients with rectal adenocarcinoma by giving them a complete pathologic response.

Who is the study for?
Adults diagnosed with locally advanced rectal adenocarcinoma who haven't had previous treatments for it. They must be in good physical condition (ECOG 0-1) and have certain high-risk features or stage II/III cancer. Participants need proper organ and marrow function, not be pregnant or nursing, agree to use contraception, and can't have HIV/AIDS, hepatitis B/C, other cancers within the last 3 years (with exceptions), serious illnesses that could affect study participation, known autoimmune diseases (with exceptions), recent live vaccines, lung disease history, or prior specific immunotherapies.Check my eligibility
What is being tested?
The trial is testing if adding APX005M to standard chemotherapy (mFOLFOX) plus radiation therapy improves complete response rates in rectal cancer patients compared to just mFOLFOX with radiation. The goal is to see which treatment better eliminates all signs of cancer before surgery.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different body parts due to APX005M; typical chemo-related issues like nausea, fatigue, blood cell count changes from mFOLFOX; and skin irritation from radiation therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have been diagnosed with rectal cancer.
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I am a woman capable of becoming pregnant and have not been surgically sterilized or menopause-free for over a year without a medical reason.
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My rectal cancer is advanced but hasn't been treated yet.
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I am a woman who can have children and have a recent negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathological Complete Response Rate
Secondary outcome measures
Disease free survival
Overall Survival
Toxicity analysis
Other outcome measures
Exploratory Immunological Response

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: APX005M on day 3 of RT & day 3 of cycles 1-5 of mFOLFOXExperimental Treatment1 Intervention
On Day 3 of Cycles 1-5 of each mFOLFOX treatment, participants will receive another dose of APX005M. The sequence of administration of APX005M in combination with mFOLFOX. In Cycle 6, participants will receive only mFOLFOX. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.
Group II: Radiation Therapy 5Gy x 5 days, mFOLFOXActive Control1 Intervention
Participants randomized to Arm 2 will receive short-course RT and mFOLFOX regimen, except that participants will not receive any of the study drug. After completing the last planned dose of mFOLFOX, participants will be considered off-protocol directed therapy and undergo planned TME, per institutional standards, and proceed to the follow-up portion of this study.

Find a Location

Who is running the clinical trial?

Apexigen America, Inc.Industry Sponsor
11 Previous Clinical Trials
582 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,741 Total Patients Enrolled
Apexigen, Inc.Industry Sponsor
11 Previous Clinical Trials
582 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are a part of this experiment?

"This study is no longer looking for new patients. The trial was first posted on April 24th, 2020 and the most recent update was made on July 14th, 2022. If you are interested in other studies, there are 1081 trials recruiting patients with advance directives and 7 different trials for APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days that are still enrolling participants."

Answered by AI

What are the potential risks associated with APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days?

"APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days is currently being evaluated in Phase 2 clinical trials. While there is some evidence supporting its safety, more data needs to be collected about the efficacy of this treatment option."

Answered by AI

Has this clinical trial been conducted before?

"Currently, there are 7 trials in progress that are studying the combination of APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days. The first clinical trial for this treatment was completed in 2017 by Apexigen, Inc. In total, 41 patients were involved in Phase 1 & 2 of the study. From 2017 to now, 3 more trials have been undertaken."

Answered by AI

Could I be a candidate for this research project?

"This trial is seeking 58 individuals who have prepared advance directives. These patients must be between 18 and 99 years of age, meet the following criteria:-18 years or older -Able to provide written informed consent -Pathologic diagnosis of rectal adenocarcinoma -Distal (<1cm from anal ring), cT4 or within 3mm of MR fascia -Not a candidate for sphincter preservation -Extramural venous invasion -No prior treatment for rectal adenocarcinoma -Eastern Cooperative Group (ECOG"

Answered by AI

Can minors participate in this research?

"To be eligible for this particular clinical trial, patients must between 18 to 99 years old. Out of the 1,102 total clinical trials hosted on this website, only 19 are for minors and 1083 are for senior citizens."

Answered by AI

What are some other similar treatments that have been tried involving APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days?

"University of Texas MD Anderson Cancer Center first studied APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days in 2017. So far, 3 clinical trials have completed with 7 more active studies underway--a large number of which are taking place in Winston-Salem, North carolina."

Answered by AI

Can new participants still sign up for this research project?

"This study is no longer recruiting patients. The earliest posting date was April 24th, 2020 and the most recent edit was on July 14th, 2022. However, there are 1081 other trials that may be of interest which are actively admitting patients with advance directives and 7 trials for APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days that are currently seeking new candidates."

Answered by AI

How many different sites are hosting this trial?

"This study has six total locations, three of which are Wake Forest Baptist Health Sciences in Winston-Salem, North carolina, Moffitt Cancer Center in Tampa, Florida, and Oregon Health & Science University in Portland, Oregon."

Answered by AI
~14 spots leftby Sep 2025