Your session is about to expire
← Back to Search
Anti-metabolites
MTB-9655 for Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by MetaboMed Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Awards & highlights
Study Summary
This trial is testing a new potential cancer treatment, MTB-9655, which is taken orally. The study will enroll up to 30 patients with advanced solid tumors who will take the drug daily. The trial will be conducted in the United States and Israel.
Who is the study for?
Adults with advanced solid tumors that are locally advanced, unresectable/metastatic, and have not responded to standard treatments or have no standard treatment options. Participants must be in good physical condition (ECOG score of 0 or 1), able to provide a tumor sample, expected to live at least 3 months, and use effective contraception if applicable.Check my eligibility
What is being tested?
MTB-9655 is being tested as an oral cancer treatment targeting the ACSS2 enzyme. This Phase 1 trial involves up to 30 patients taking varying doses to find the safest and most effective level. It's open-label so everyone knows they're getting MTB-9655, and it includes dose escalation.See study design
What are the potential side effects?
Specific side effects for MTB-9655 aren't listed but may include typical reactions seen with cancer medications such as nausea, fatigue, blood count changes, liver function alterations, digestive issues or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events following administration of MTB-9655
Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy
Part A: Number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.
+1 moreSecondary outcome measures
Disease control rate based on RECIST 1.1
Duration of response based on RECIST 1.1
Overall response rate in participants receiving MTB-9655
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Part A Dose-Escalation and Part B RP2D Dose-ExpansionExperimental Treatment1 Intervention
Study has two parts:
Part A Dose-Escalation will evaluate MTB-9655 monotherapy administered in 21 days cycle,and will be conducted in 2 stages (accelerated titration and dose-escalation).
The first stage will consist of accelerated titration in single-patient cohorts for the initial two dose levels.
In the second stage, a conventional 3+3 schema using a modified Fibonacci dose titration strategy will be implemented. The first dose at every dose level and in every patient will be administered under close medical supervision, and the patients will be hospitalized for approximately 24 hours.
Up to 30 participants will participate in this dose escalation arm.
Part B dose-expansion will further explore the safety, PK and preliminary efficacy of MTB-9655 at the RP2D. The RP2D level will be no higher than the MTD identified in Part A.
Find a Location
Who is running the clinical trial?
MetaboMed IncLead Sponsor
Meredith McKean, MDStudy ChairSCRI Development Innovations, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a type of cancer that has spread and cannot be removed by surgery. You have already tried standard treatments or choose not to receive them. Your cancer type does not have any proven effective treatments available or does not respond to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part A Dose-Escalation and Part B RP2D Dose-Expansion
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.
Is enrollment in this trial currently underway?
"According to clinicaltrials.gov, this investigation is actively looking for volunteers and was first advertised on June 30th 2021. The original post has been revised most recently on December 15th 2021."
Answered by AI
Would taking MTB-9655 result in any detrimental effects on human health?
"Given the limited safety and efficacy data, MTB-9655 only received a score of 1."
Answered by AI
What is the current participant count of this research project?
"Affirmative, the information hosted on clinicaltrials.gov shows that this investigation into new treatments is actively recruiting patients. This study was first publicized June 30th 2021 and underwent recent modifications December 15th of the same year. A total of thirty people need to be recruited from one medical centre for participation in the trial."
Answered by AI
What outcomes is this clinical experiment attempting to accomplish?
"This 21-day medical trial seeks to establish the Maximum Tolerated Dose (MTD) for participants receiving MTB-9655 monotherapy by tracking any associated Dose Limiting Toxicities (DLTs). Secondary goals include monitoring Progression Free Survival, Duration of Response and Disease Control Rate based on RECIST 1.1 criteria."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger