Your session is about to expire
Study Summary
This trial is testing a new drug, IDRX-42, for safety, how well it is tolerated, and its effects on tumors in people with advanced GIST.
Who is the study for?
Adults with advanced GIST that can't be surgically removed or has spread, who have tried other treatments like imatinib and possibly others without success. They should be in good physical condition (ECOG 0-1) and have recovered from previous treatment side effects.Check my eligibility
What is being tested?
The trial is testing IDRX-42's safety, how well it's tolerated by the body, its pharmacokinetics (how the drug moves through the body), and its initial effectiveness in treating GIST.See study design
What are the potential side effects?
Since this is a first-in-human study for IDRX-42, specific side effects are not yet known but will likely include typical cancer drug reactions such as nausea, fatigue, risk of infection, and potential organ-related toxicities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 (Dose Escalation) - Determination of the MTD and/or RP1bD(s) of orally administered IDRX-42
Phase 1 (Dose Escalation) - Safety and Tolerability (Nature, incidence, and severity of any DLTs)
Phase 1b - Objective Response Rate (ORR) mRESIST v1.1
+1 moreSecondary outcome measures
Phase 1 (Dose Escalation) - AUC 0-24; Area Under the Concentration-time Curve from Time Zero to 24 hours for IDRX-42
Phase 1 (Dose Escalation) - Cmax; Maximum Observed Concentration of IDRX-42
Phase 1 (Dose Escalation) - Duration of response (DOR) per mRECIST v1.1
+13 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Dose Escalation (Phase I)Experimental Treatment1 Intervention
Participants should have advanced (metastatic and/or surgically unresectable) GIST, following failure of at least prior imatinib therapy due to progression of GIST.
Group II: (Phase 1b): Cohort 4Experimental Treatment1 Intervention
Participants with GIST progression who meet the same criteria as Cohort 2 (third line or greater TKI therapy) and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination.
Group III: (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïveExperimental Treatment1 Intervention
Participants with metastatic and/or surgically unresectable GIST who are treatment naïve (first line therapy) and refused or are ineligible for other standard of care (SOC) therapies.
Group IV: (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapyExperimental Treatment1 Intervention
Participants with metastatic and/or surgically unresectable GIST following progression EITHER after sequential imatinib then sunitinib (third-line therapy setting) OR after imatinib, sunitinib, and then an additional TKI agent (i.e., regorafenib or ripretinib) (fourth-line therapy setting) OR after imatinib, sunitinib, regorafenib, and ripretinib (5th line or greater therapy).
Group V: (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapyExperimental Treatment1 Intervention
Participants with advanced GIST who have had GIST progression after first-line imatinib only (second line therapy setting) and refused or are ineligible for other standard of care (SOC) therapies.
Find a Location
Who is running the clinical trial?
IDRx, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Any side effects from my previous treatments are mild or gone.My cancer progressed after treatment with imatinib and sunitinib, or after these plus another drug.I am 18 years old or older.I have never had brain cancer or untreated brain metastases.I have serious heart problems that are not under control.My GIST cannot be removed with surgery and is confirmed by lab tests.I do not have an active infection requiring IV antibiotics.I have a tumor that can be measured according to specific criteria.My GIST lacks mutations in both KIT and PDGFRA genes.My cancer has worsened despite taking imatinib.I am fully active or can carry out light work.My condition worsened after only using imatinib as a second treatment.My GIST has not responded to all approved TKI treatments.My cancer has a specific mutation in the KIT gene or a PDGFRA mutation that is not in exon 18.
Research Study Groups:
This trial has the following groups:- Group 1: (Phase 1b): Cohort 4
- Group 2: (Phase 1b): Cohort 2 - Participants with GIST progression after 2 or more lines of TKI therapy
- Group 3: (Phase 1b): Cohort 3 - Participants with GIST who are treatment naïve
- Group 4: Dose Escalation (Phase I)
- Group 5: (Phase 1b) Cohort 1 - Participants with GIST progression after first-line imatinib therapy
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.
What is the current enrollment figure of this investigation?
"Affirmative. The available information on clinicaltrials.gov suggests that this trial is actively recruiting participants, having initially been posted on August 1st 2022 and most recently revised on October 26th 2022. A total of 143 volunteers are required to be admitted across one medical facility."
Answered by AI
Are there opportunities to participate in this trial at present?
"A review of clinicaltrials.gov confirms that this medical study is enlisting subjects, having been first posted on August 1st and last edited on October 26th 2022."
Answered by AI
What safety protocols are in place for the application of IDRX-42 to patients?
"Due to the limited clinical data available, IDRX-42 was assigned a 1 on our safety scale. As this is a Phase 1 trial, there are only preliminary results regarding efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger