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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

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

50%

Localized Tumor-Related Pain

33%

Fatigue

22%

Nausea

17%

Vomiting

17%

Rash Maculo-papular

17%

Pruritis

11%

Dizziness

11%

Pyrexia

11%

Anaemia

11%

Headache

11%

Chills

11%

Decreased Appetite

Haemoptysis

Abdominal Pain

Colitis

Erythema

Tumor Necrosis

Groin Pain

Pneumonitis

Injection Site Induration

Back Pain

Dry Skin

Dysgeusia

Cough

Dyspnoea

Pruritus Genital

Dysuria

Injection Site Odema

Parathesia

Hyperglcaemia

Abdominal Distention

Rash Erythematous

Arthralgia

Hypothyroidism

Alanine Aminotransferase Increased

Aspartate Aminotransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

INT 230-6 Combined With Ipilimumab (Cohort FEC)

Monotherapy: (Cohort EC3)

Monotherapy: (Cohort B1)

INT230-6 Combined With Pembrolizumab (Cohorts DEC)

Monotherapy: (Cohort E-C)

INT230-6 Combined With Pembrolizumab (Cohorts DEC2)

Monotherapy: (Cohort A1)

Monotherapy: (Cohort E-A)

Monotherapy: (Cohort EC-2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 treatment sessions (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 of INT230-6 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 or disease progression * Trabectedin: 1.5 mg/m2 body surface area as 24-hour IV infusion every 3 weeks until clinical deterioration or disease progression * 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 or disease progression EU sites: 1.23 mg/m2 (free base) body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration or disease progression

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INT230-6

2017

Completed Phase 2

~120

0 / 5Eligibility criteria met