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OBI-999 for Advanced Cancers
Study Summary
This trial is testing a new drug to see what the maximum amount someone can take without having severe side effects, as well as what dose could be recommended for further studies.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- This study is specifically for people with pancreatic cancer.You have previously received treatment specifically targeting Globo H.You are allergic to OBI 999 or any of its ingredients.You have a serious heart condition like heart failure or unstable angina.This study is looking for people with esophageal cancer to participate in Cohort 2.This clinical trial is for people with gastric cancer specifically.This study is specifically looking for people with colorectal cancer.You have moderate or worse nerve damage affecting your ability to feel or move.
- Group 1: OBI-999 Expansion Phase
- Group 2: OBI-999 Escalation phase
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any empty slots currently available for this research program?
"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting participants, which began on December 10th 2019 and was recently refreshed on July 5th 2022. 185 individuals are required at 4 sites for the study's completion."
What aims does this trial seek to attain?
"This research study's primary objective is to determine the maximum tolerated dose of OBI-999 and an ideal dosage for Phase 2. Secondary aims include analysing pharmacokinetic parameters such as time to peak concentration (Tmax) and volume of distribution (Vd), along with assessing preliminary clinical activity profiles in terms of duration of response (DOR). The data collection period will cover 21 consecutive days per cycle."
Are there numerous venues providing access to this research?
"Several research centres are taking part in this trial, including the University of Texas MD Anderson Cancer Center in Houston and West Cancer Center located in Germantown. The Scripps MD Anderson Cancer Centre based in La Jolla is also participating amongst a few other sites."
To what extent is participation in this trial widespread?
"This clinical trial is looking to bring on board 185 participants who meet the particular criteria for inclusion. Those interested in taking part can reach out to University of Texas MD Anderson Cancer Center within Houston, or West Cancer Center near Germantown, Tennessee."
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