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Virus Therapy

INT230-6 for Chordoma (IT-01 Trial)

Phase 1 & 2
Waitlist Available
Led By Anthony J. Olszanski, M.D., RPh
Research Sponsored by Intensity Therapeutics, 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 up to 5 years
Awards & highlights

IT-01 Trial Summary

This trial is testing a new drug, INT230-6, to see if it can shrink tumors in people with cancer that has spread and can't be removed with surgery. The study will also test if combining INT230-6 with other drugs might work better than INT230-6 alone.

Eligible Conditions
  • Chordoma
  • Cholangiocarcinoma
  • Lung Cancer
  • Sarcoma
  • Pancreatic Cancer
  • Liver Cancer
  • Colon Cancer
  • Breast Cancer
  • Head and Neck Cancers
  • Squamous Cell Carcinoma
  • Lymphoma

IT-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Rate and severity of treatment-emergent adverse events ≥ grade 3 attributed to study drug using the NCI Common Terminology Criteria for Adverse Events (CTCAE v.4.03) (Scale 1 to 5)
Secondary outcome measures
Determine key pharmacokinetic parameter, Area Under the Curve (AUC) (ng*hr/mL) of each of the 3 main components of INT230-6.
Determine pharmacokinetic parameter Peak Plasma (Cmax in ng/mL) of each of the 3 main components of INT230-6.
Key pharmacokinetic parameters, half live (hours) of each of the 3 main components of INT230-6.
+1 more
Other outcome measures
Exploratory: Blood, Genetic and Tissue Biomarker Identification from cell flow phenotyping, tissue analysis, genetic SNP analysis.
Exploratory: Control or Regression of Non Injected Tumors by Measurement of Length (in centimeters) Radio-graphically Using Computer Tomography or Magnetic Resonance Imaging.
Exploratory: Overall Subject Outcome

IT-01 Trial Design

9Treatment groups
Experimental Treatment
Group I: FEC: INT230-6 combined with ipilimumabExperimental Treatment1 Intervention
INT230-6 per the EC3 regimen combined with Yervoy (ipilimumab) dosed concurrently starting at Day 1 every 3 weeks for four treatments for selected cancer types. Completed
Group II: EC3: INT230-6 monotherapy fixed maximal doseExperimental Treatment1 Intervention
INT230-6 injections every 2 weeks for 5 sessions at fixed maximal dose into superficial or deep tumors, unlimited number of tumors to be treated per session with retreatment once every 9 weeks for two years. Completed
Group III: DEC2: INT230-6 combined with pembrolizumabExperimental Treatment2 Interventions
INT230-6 per the dosing of cohort EC3 combined with Keytruda (pembrolizumab) dosed per DEC concurrently starting at Day 1 for selected cancers. Completed
Group IV: Cohort EC2Experimental Treatment1 Intervention
INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, high starting dose, moderate drug concentration per tumor, higher number of tumors to be treated per session than EC Completed
Group V: Cohort ECExperimental Treatment1 Intervention
INT230-6 injections every 2 weeks for 5 sessions into superficial or deep tumors, moderately high starting dose, high drug concentration per tumor Completed
Group VI: Cohort EAExperimental Treatment1 Intervention
INT230-6 injections every 2 weeks for 5 sessions into superficial tumors, medium starting dose, low drug concentration per tumor Completed
Group VII: Cohort DEC: Safety with INT230-6Experimental Treatment2 Interventions
INT230-6 injections every 2 weeks for 5 sessions with the possibility for INT230-6 retreatment into superficial tumors, with addition of anti-PD-1 antibody Keytruda (pembrolizumab) dosed concurrently starting at Day 1 every 3 weeks for two years for selected cancer types. Completed
Group VIII: Cohort B1Experimental Treatment1 Intervention
INT230-6 injections every 28 days for 5 sessions into deep tumors, low starting dose, low drug concentration per tumor Completed
Group IX: Cohort AExperimental Treatment1 Intervention
INT230-6 injections every 28 days for 5 sessions into only superficial tumors, low starting dose, low concentration per tumor. Completed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
anti-CTLA-4 antibody
2017
Completed Phase 2
~110
INT230-6
2017
Completed Phase 2
~110
anti-PD-1 antibody
2017
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Intensity Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
423 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,890 Previous Clinical Trials
5,060,191 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,354 Total Patients Enrolled
4 Trials studying Chordoma
446 Patients Enrolled for Chordoma

Frequently Asked Questions

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

Have any other research projects explored the properties of INT230-6?

"INT230-6 was first trialled in 2009 at Texas Children's Hospital. To date, 422 trials have been completed and 1254 are currently enrolling participants - many of which can be found in Toronto, Ontario."

Answered by AI

Are there numerous outposts conducting this experiment throughout Canada?

"This clinical trial is offering 8 different opportunities for participation, including at Princess Margaret Cancer Center - University Health Network in Toronto, UMASS Memorial Medical Center in Worcester, and Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore. Additional locales are available."

Answered by AI

Is there still an opportunity to join this experiment?

"At this point, no further participants are being sought for this trial. Initially posted on February 9th 2017 and last modified June 21st 2022, it has since concluded its recruitment process. For those looking for alternative trials, 4823 studies related to sarcoma have open recruitments as do 1254 INT230-6 specific investigations."

Answered by AI

What is the approximate size of the cohort being observed in this trial?

"Unfortunately, this clinical research has concluded its recruitment of participants. It was initially posted on February 9th 2017 and had its last update on June 21st 2022. If you are seeking out other medical experiments to participate in, there are 4823 studies recruiting sarcoma patients and 1254 trials admitting individuals for INT230-6 treatment."

Answered by AI

What medical conditions is INT230-6 usually prescribed to treat?

"Patients with unresectable melanoma, high microsatellite instability, and a heightened risk of relapse can be treated using INT230-6."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6
2017. "A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03058289.
~13 spots leftby Apr 2025
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