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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
An adequate tumor sample must be available from core needle biopsies obtained during the Screening Period and following the subject's most recent systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study Summary
This trial is testing a new drug, CBX-12, on people with cancer that has spread or returned after treatment. The goal is to see if it is safe and what side effects it has.
Who is the study for?
This trial is for adults with advanced or metastatic solid tumors that have worsened after treatment, or when no approved therapy exists. Participants must have measurable disease and provide tumor samples. They can't join if they've had certain treatments within 3 weeks (2 weeks for some cases) before starting the study, are on other cancer treatments, have significant diseases, or active brain metastases without approval.Check my eligibility
What is being tested?
CBX-12 is being tested in this Phase 1/2 trial to evaluate its safety and how it affects the body (pharmacokinetics). It's an open-label study where everyone gets CBX-12; there's a dose-escalation phase to find the right amount of drug that's safe and potentially effective.See study design
What are the potential side effects?
Since CBX-12 is new and this is a first-in-human study, specific side effects aren't listed yet. Generally, such trials watch out for any signs of organ inflammation, allergic reactions to the drug infusion, fatigue, nausea or other digestive issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has worsened after treatment, or no approved treatment exists for it.
Select...
I have a recent tumor sample from a needle biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 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: Incidence of treatment-emergent adverse events (TEAEs)
Phase 1: Recommended Phase 2 Dose for Daily x 3 every 3 weeks schedule of CBX-12 (Schedule B)
Phase 1: Recommended Phase 2 Dose for Once Every 3 Weeks schedule of CBX-12 (Modified Schedule B)
+2 moreSecondary outcome measures
Apparent Volume of Distribution at Steady State (Vss) CBX-12
Area under the curve from 0-24 hours of CBX-12
Clearance (CL) of CBX-12
+7 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase 2 Ovarian Cancer Expansion CohortExperimental Treatment1 Intervention
CBX-12 administered TBD
Group II: Phase 2 Metastatic Breast Expansion CohortExperimental Treatment1 Intervention
CBX-12 administered TBD
Group III: Phase 1 Schedule C Dose Escalation (Once Weekly Dosing )Experimental Treatment1 Intervention
CBX-12 administered once weekly, 4 week schedule
Group IV: Phase 1 Schedule B Dose Escalation (Daily Dosing x 3)Experimental Treatment1 Intervention
CBX-12 administered on a daily x 3, 3 week schedule
Group V: Phase 1 Schedule A Dose Escalation (Daily Dosing x 5)Experimental Treatment1 Intervention
CBX-12 administered on a daily x 5, 3 week schedule
Group VI: Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks)Experimental Treatment1 Intervention
CBX-12 administered once every 3 weeks
Find a Location
Who is running the clinical trial?
Cybrexa TherapeuticsLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Chief Medical OfficerStudy DirectorCybrexa Therapeutics
122 Previous Clinical Trials
21,394 Total Patients Enrolled
1 Trials studying Sarcoma
25 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any small-molecule kinase inhibitors or hormonal agents in the last 14 days.I have brain metastases but they are stable, or I have approval to join.I have a serious health condition besides cancer.I agree to a biopsy of the same lesion as before, if it's safe.My advanced cancer has worsened after treatment, or no approved treatment exists for it.I have a recent tumor sample from a needle biopsy.I haven't had chemotherapy, radiation, or other cancer treatments in the last 3 weeks.You have a disease that can be measured using a specific method called RECIST 1.1.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Metastatic Breast Expansion Cohort
- Group 2: Phase 1 Schedule A Dose Escalation (Daily Dosing x 5)
- Group 3: Phase 1 Schedule C Dose Escalation (Once Weekly Dosing )
- Group 4: Phase 1 Modified Schedule B Dose Escalation (Once Every 3 weeks)
- Group 5: Phase 1 Schedule B Dose Escalation (Daily Dosing x 3)
- Group 6: Phase 2 Ovarian Cancer Expansion Cohort
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.
Sarcoma Patient Testimony for trial: Trial Name: NCT04902872 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has the study recruited thus far?
"Affirmative. According to clinicaltrials.gov, this research program is enrolling patients at 4 distinct locations and the study has been active since May 3rd 2021. 112 individuals are eagerly sought after by researchers involved in the trial."
Answered by AI
Is the clinical trial for this study being administered widely across North America?
"Presently, this trial is being run in 4 different sites located in Austin, San Antonio and New Haven among other places. Participants should select the closest clinical centre to reduce travel inconveniences."
Answered by AI
What is the primary purpose of this research endeavor?
"This trial will span 15 months and the primary outcome is to be evaluated by measuring overall response rate (ORR). The secondary outcomes are Area under the Curve from 0-24 hours of CBX-12, Clearance (CL) of CBX-12, and Maximum concentration of CBX-12 as defined through PK Analysis."
Answered by AI
Are there opportunities to join the research team of this experiment?
"Affirmative, the information found on clinicaltrials.gov suggests that this investigation is presently enrolling participants. This clinical trial was initially uploaded on May 3rd 2021 and recently modified on May 9th 2022. The research requires 112 individuals from 4 various sites to take part in it."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
NEXT Oncology
Yale Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Completed all rounds of Chemo - cisplatin and etoposide, plus 32 rounds of radiation to chest. concerned that SCLC will return.
PatientReceived 2+ prior treatments
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