Open Menu

Meetings & Education

Research & Data

Practice & Patients

Career Development

News & Initiatives

Get Involved

A multicenter, randomized, global phase 3 study to assess the efficacy and safety of intratumoral (IT) INT230-6 (SHAO, vinblastine, cisplatin) as monotherapy compared with standard of care systemic chemotherapy in adults with locally recurrent, inoperable, or metastatic soft tissue sarcomas (STS; INVINCIBLE-3).

Background: Soft tissue sarcomas (STS) are a rare and diverse set of tumors. Systemic chemotherapy provides limited benefit for metastatic disease. INT230-6 is a novel formulation of cisplatin (CIS) and vinblastine (VIN) with a tissue dispersion enhancer (SHAO). The drug’s unique chemistry permits dispersion throughout tumors and diffusion into the cancer cells after IT injections. The drug causes apoptosis and recruits T-cells to the tumor. An open-label, phase 1/2 study was completed with locally advanced, unresectable, or metastatic adult patients with 11 STS subtypes. Patients had a median of 3 prior lines. Biopsied tissue from pre- and post-dosed tumors2 showed immune engagement post-dose. PK data showed that >95% of VIN stayed in the tumor. There were no dose-limiting toxicities up to 175 mL (87.5 mg CIS, 17.5 mg VIN). The disease control rate was 93%. Uninjected tumors shrank. The median OS for INT230-6 alone (n=15) was 21.3 CI (4.7, NR) months. The maximum severity of INT230-6 treatment-related adverse events (TRAEs) in STS patients was 6.7% grade 1, 60% grade 2, and 33% grade 3 (no related grade 4 or 5 AEs). The most common TRAEs were pain, fatigue, and nausea.

Methods: IT-03 is a 2:1 randomized trial comparing INT230-6 as monotherapy to an investigator’s choice of pazopanib, trabectedin, or eribulin, per label. A total of 333 patients in 2L/3L will be enrolled in the US, Canada, Europe, and Australia. INT230-6 dose is set by tumor size. INT230-6 is given IT Q2W for up to 5 doses to as many tumors >1 cm as is deemed safe. Maintenance is Q12 weeks for up to 22 months. Statistics: 90% power to detect a survival HR of 0.65 with 3 interim assessments at 20%, 40%, and 60% of participants events (deaths). The final analysis is at 80% of events. There is a two-sided total alpha = 0.05, allocated as follows: interim #1 = 0.0039; #2 = 0.0184; final = 0.043. Includes up to 60 sites: several sites are now recruiting.

Inclusion criteria:

Must be ≥ 18 yo, and provide written consent,
Proven, unresectable, locally advanced, or metastatic STS;
Must have received at least one line of therapy and progressed after anthracycline therapy.
1 tumor for injection of at least 2 cm.
Adequate organ function in screening; lab values of:
Neutrophils ≥ 1500/μL (≥ 1.5× 109/L).
PT, and INR ≤ 1.5× ULN, platelets ≥ 100,000/μL; hemoglobin ≥ 9 g/dL. Criteria must be met without erythropoietin dependency or packed red blood cell transfusion within last 2 weeks.
Creatinine normal; or clearance > 50 mL/min by the C-G equation.
ALT SGOT/ AST SGPT ≤ 2.5× ULN without, and ≤ 5× ULN with hepatic metastases.
Bilirubin (BR) ≤ 1.5× ULN (except those with Gilbert’s syndrome, who must have total BR ≤ 3.0 mg/dL [< 52 µmol/L]).
CPK ≤ 2.5× ULN

Disclaimer

Author Details

Sant Chawla

Sarcoma Oncology Center, Santa Monica, CA

Authors chevron_right

Associated Organizations chevron_right

Abstract Details

Meeting

2025 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Sarcoma

Track

Sarcoma

View MoreAbstract Disclosure
open_in_new

Company Logo

Your Privacy

ASCO is committed to transparency regarding our websites and the ways we process data. When you visit our site, we may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences, your location, or your device and is mostly used to make the site work as you expect it to and to personalize your web experience with us.

Because we respect your right to privacy, you can choose not to allow some or all types of cookies. Click on the different category headings to find out more about the types of cookies used on our websites and change your default settings to match your preferences. Please read these carefully. Blocking some types of cookies may impact your experience on the site, including our ability to personalize the content you receive from us.

For a full explanation of the personal and non-personal information we collect on our site, including how we use that information and your rights regarding that information, please review our Privacy Policy. Use of our website is also subject to our Terms of Use.

Allow All

Essential Website Cookies

Always Active

These cookies are necessary for the website to function and are sometimes referred to as “strictly necessary” cookies. They make sure the website delivers you information and services in an optimal way.

They are often set in response to an action you take, such as changing your cookie preferences, setting your privacy preferences, logging in to our website, asking the site to remember you on subsequent pages, or filling in forms. These cookies do not identify you personally.

You can set your browser to block or alert you about all cookies, including essential website cookies, but some parts of the site will not work as a result.

Cookies Details‎

Performance and Functionality Cookies

These cookies enhance the performance and functionality of our websites and the services we provide. For example, these cookies can keep track of your visitor session in between visits, enable you to share content through social media, use embedded media players, and use comment features. They also help us balance website load and improve site speed and performance.

All information these cookies collect is aggregated and therefore anonymous. These cookies may be set by us or by third party providers whose services we have added to our websites. These cookies are non-essential, but without these cookies, certain functionality or enhanced features may become unavailable.

Cookies Details‎

Personalization and Analytics Cookies

These cookies collect information that is used to help us understand how our websites and content are used, help us customize our websites and application for you in order to enhance your experience, and help us improve the content that ASCO creates to better meet our members’ and visitors’ needs. Examples include cookies that show us which content might be most popular with our visitors, understand browsing history of our users, understand the effectiveness of our own advertising, and enable us to recommend content to individual users based on their profile and activities on the website.

These cookies may be set by us or by third party providers whose services we have added to our websites.

These cookies are non-essential to the functionality of the site and may contain information that enables us or our third party providers to identify you and build a profile of your interests. Without these cookies, you will not be able to have a customized or personalized experience within our website.

Cookies Details‎

Advertising Cookies and Social Media Cookies

Advertising (or Targeting) cookies are third party cookies that may be set through our site by our advertising partners. They may be used by those companies to build a profile of your interests and show you relevant ads on other sites.

Social Media Cookies are cookies set by a range of social media services that we have added to the site to enable you to share our content with your friends and networks. They are capable of tracking your activities across other sites and building a profile of your interests. This may impact the content and messages you see on other websites you visit.

These cookies and the data collected by the third parties may be combined with data from other users or data about your activity on other sites. While the data collected on our site is aggregate or non-personal, the data may be used by such third parties to link you on other platforms or otherwise identify you.

If you do not allow these cookies, you may experience less targeted advertising.

Cookies Details‎

Back Button

Search Icon

Filter Icon

Clear

checkbox labellabel

ApplyCancel

ConsentLeg.Interest

checkbox labellabel