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Virus Therapy

INT230-6 for Soft Tissue Sarcoma (INVINCIBLE-3 Trial)

Phase 3
Recruiting
Led By Christian F. Meyer, MD, PhD, MS
Research Sponsored by Intensity Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven, unresectable, locally advanced, or metastatic Soft Tissue Sarcoma (STS) only of the following subtypes: liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic), leiomyosarcoma (non-uterine), and undifferentiated pleomorphic sarcoma. Participant must have a pathology report indicating the diagnosis of their STS.
Participant must have at least 1 target tumor suitable for injection using routine image guidance ≥ 2 cm measurable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
Awards & highlights

Summary

This trial aims to compare the overall survival of patients with certain types of advanced soft tissue sarcomas who have already tried 2 standard treatments, including one with anthracycline, with a new

Who is the study for?
Adults with specific types of Soft Tissue Sarcoma (liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma) that can't be surgically removed or has spread. They should have tried an anthracycline-based treatment and up to one more therapy without success. Their tumors must be visible on scans and they need to be physically well enough for daily activities.
What is being tested?
The trial is testing INT230-6 against the US Standard of Care treatments like Eribulin, Trabectedin, and Pazopanib in patients whose sarcomas have worsened after previous treatments. The main goal is to see if INT230-6 helps patients live longer compared to standard options.
What are the potential side effects?
Possible side effects from the drugs being tested could include fatigue, nausea, hair loss from chemotherapy (like Eribulin), liver toxicity (from Trabectedin), high blood pressure and abnormal heart rhythm (from Pazopanib). Specific side effects of INT230-6 are not listed but may be similar.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My sarcoma is one of the specified types and cannot be surgically removed.
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I have a tumor larger than 2 cm that can be targeted for injection.
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I am able to care for myself and perform daily activities.
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My kidney function, measured by creatinine levels, is normal.
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I am 18 or older and can give my consent, or someone legally allowed can consent for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma
Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma

Side effects data

From 2023 Phase 1 & 2 trial • 111 Patients • NCT03058289
33%
Localized Tumor-Related Pain
17%
Groin Pain
17%
Chills
17%
Erythema
17%
Myalgia
17%
Dry mouth
17%
Wound Infection
17%
Blister
17%
Fatigue
17%
Injection Site Haemorrhage
17%
Mucosal Inflammation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy: (Cohort A1)
Monotherapy: (Cohort B1)
Monotherapy: (Cohort E-A)
Monotherapy: (Cohort E-C)
Monotherapy: (Cohort EC-2)
Monotherapy: (Cohort EC3)
INT230-6 Combined With Pembrolizumab (Cohorts DEC)
INT230-6 Combined With Pembrolizumab (Cohorts DEC2)
INT 230-6 Combined With Ipilimumab (Cohort FEC)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INT230-6 MonotherapyExperimental Treatment1 Intervention
INT230-6 administered intratumorally. Participants will be dosed every 2 weeks (± 2 days) for up to a total of 5-cycles (e.g., Days 1, 15, 29, 43 and 57). Once the participant has completed the treatment phase, they will continue into a 22-month maintenance phase, where investigators may inject new lesions or previously injected lesions with up to 175 mL every 12 weeks (Q12W) ± 14 days. Dose volume in a session is dependent on the participants presenting tumor burden.
Group II: US Standard of CareActive Control3 Interventions
Participants in this arm may receive any of the following depending on Soft tissue sarcoma (STS) subtype and PI preference: * Pazopanib: 800 mg PO every day until clinical deterioration * Trabectedin: 1.5 mg/m2 body surface area as 24-hour IV infusion every 3 weeks until clinical deterioration * Eribulin: Non- European Union (EU) sites: 1.4 mg/m2 eribulin mesylate body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration EU sites: 1.23 mg/m2 (free base) body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INT230-6
2017
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
73,536 Total Patients Enrolled
Intensity Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
201 Total Patients Enrolled
Christian F. Meyer, MD, PhD, MSPrincipal InvestigatorJohns Hopkins University
~222 spots leftby Dec 2027
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