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Sarcoma,Soft TissuePhase 3INVINCIBLE-3NCT06263231

A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

A Phase 3 study testing INT230-6, Eribulin and Trabectedin in people with Sarcoma,Soft Tissue, run by Intensity Therapeutics, Inc. at 17 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma,Soft Tissue
What is being tested?
INT230-6, Eribulin and Trabectedin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
17 sitesin 5 countries
Study dates
28 Jun 2024to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study.
  • Type of Participant and Disease Characteristics
  • Histologically proven, unresectable, locally advanced, or metastatic Soft Tissue Sarcoma (STS) only of the following subtypes: liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic), leiomyosarcoma, and undifferentiated pleomorphic sarcoma. Participant must have a pathology report indicating the diagnosis of their STS.
  • Participant must have received at least 1 line of therapy for a STS and must have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused by participant. Participant cannot have received more than 2 prior regiments for unresectable, locally advanced or metastatic STS.
  • Participant must have measurable disease per RECIST 1.1 criteria.
  • 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).
Show all 18Show fewer
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (see Section 11.7).
  • Participant must have adequate organ function as defined by screening laboratory values that must meet the following criteria:
  • Neutrophils ≥ 1500/μL (≥ 1.5× 109/L).
  • Prothrombin Time (PT), and International Normalized Ratio (INR) ≤ 1.5× Upper Limit of Normal (ULN), platelets ≥ 100,000/μL (≥ 10× 109/L); hemoglobin ≥ 9 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks.
  • Creatinine within normal range; or calculated creatinine clearance > 50 mL/min by the Cockcroft-Gault equation.
  • Alanine Aminotransferase (ALT) Serum Glutamic-Oxaloacetic Transaminase (SGOT)/ Aspartate Aminotransferase (AST) Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2.5× ULN without, and ≤ 5× ULN with hepatic metastases.
  • Bilirubin ≤ 1.5× ULN (except participants with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL [< 52 µmol/L]).
  • Creatine phosphokinase < 2.5× ULN Sex and Contraceptive/Barrier Requirements
  • A female participant is eligible to participate if she is not pregnant (as demonstrated by pregnancy testing prior to each treatment; performed at least monthly), not breastfeeding, and at least 1 of the following conditions applies:
  • Not a Woman of Childbearing Potential (WOCBP). Women of non-childbearing potential are defined as women with functioning ovaries with a documented history of tubal ligation or hysterectomy or females who are post menopausal, as defined by 12 months of spontaneous amenorrhea with an appropriate clinical profile, e.g., age appropriate, > 45 years, in the absence of hormone replacement therapy. In questionable cases, a blood sample for Follicle Stimulating Hormone (FSH) and estradiol will be obtained to confirm childbearing potential.
  • A WOCBP who may become pregnant or who is sexually active with a partner and who could become pregnant agrees to use a highly effective form of contraception during the study and for at least 7 months after the end of study intervention (see Section 11.5.2 for highly effective methods of contraception).
  • Male participants with female partners of childbearing potential must agree to use contraception and refrain from sperm donation during the study and for 6 months after the end of study intervention (Section 11.5.2.2).

Who cannot join

  • Informed Consent:
  • Adult participants who lack capacity to consent without a legally authorized representative will be excluded from this study.
  • Medical Conditions:
  • Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.
  • History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients.
  • Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans.
Show all 26Show fewer
  • Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or superficial bladder cancer, or any other cancer from which the participant has been disease-free for at least 2 years.
  • Underlying medical condition that, in the investigator's opinion, will make the administration of study intervention hazardous or obscure the interpretation of toxicity determination or Adverse Events (AEs).
  • Concurrent medical condition requiring the use of immunosuppressive medications, or systemic corticosteroids (topical steroids are permitted); systemic corticosteroids must be discontinued at least 4 weeks prior to dosing.
  • Inhaled or intranasal corticosteroids (with minimal systemic absorption) may be continued if the participant is on a stable dose. Non-absorbed intra-articular steroid injections will be permitted. Use of steroids as prophylactic treatment for participants with contrast allergies to diagnostic imaging contrast dyes will be permitted.
  • Participants who require uninterrupted anticoagulants of any type or is on daily aspirin therapy or NSAIDS.
  • Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen or hepatitis C antibodies are allowed provided they do not have active disease requiring antiviral therapy).
  • Myocardial infarction within 6 months before enrollment, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
  • Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing active infection or psychiatric illness/social situation that may potentially impair the participant's compliance with study procedures.
  • Participants with a Corrected QT interval (QTc) of >450 ms for men and >470 ms for women, or with a history of serum electrolyte abnormalities known to prolong the QT interval such hypocalcemia, hypokalemia, and hypomagnesemia, or a family or personal history of congenital long QT syndrome.
  • Participants actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).
  • Participants actively receiving therapy with medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study intervention.
  • Prior/Concomitant Therapy
  • Prior chemotherapy or immunotherapy (tumor vaccine, cytokine or growth factor given to control the cancer: systemic or IT) must have been completed at least 4 weeks prior to dosing (with the exception of kinase inhibitors or other short half-life drugs, a 2-week washout is acceptable prior to treatment) and all AEs have either returned to baseline or stabilized. Note: participants who have received prior platinum therapy are eligible irrespective of their response. If participant had received one of the 3 US SOC study regimens prior to enrollment, that previous US SOC cannot be assigned in this study.
  • Prior systemic radiation therapy (IV, intrahepatic or oral) completed at least 4 weeks prior to study intervention administration. Prior focal radiotherapy completed at least 2 weeks prior to study intervention administration.
  • Prior major treatment-related surgery completed at least 4 weeks prior to study intervention administration.
  • Use of other investigational drugs (drugs not marketed for any indication) within 28 days prior to study intervention administration.
  • Received a live vaccine within 6 weeks of first dose of study intervention.
  • Received a Coronavirus Disease (COVID-19) vaccine less than 1 week prior to dosing (Cycle 1/Day 1) and/or during the study received a COVID-19 vaccine or booster less than 3 weeks ahead of a tumor assessment.
  • Other Exclusion Criteria
  • Pregnancy Exclusion: A WOCBP who has a positive pregnancy test (e.g., within 72 hours) prior to treatment. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Trial locations and contacts

17 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Kimberly Guedes, RN, M.B.A contact

(203) 293-4224

KGuedes@intensitytherapeutics.com

Lewis H Bender, MS, MA, MBA contact

(203) 221-7377

LBender@intensityTherapeutics.com

17 sites in 5 countries

United States10 sites, 10 recruiting

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

    David Liebner, MD, David.Liebner@osumc.edu

    David Liebner, MD

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Richard Riedel, MD, 919-681-6932, richard.riedel@duke.edu

    Richard Riedel, MD

    Recruiting

  • Profound Research LLC

    Farmington Hills, Michigan, 48333

    Ines Sampson, 248-477-0552, ines.sampson@profounresearch.io

    Savitha Balaraman, MD

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Sandy Tran, MD, 626-688-7013, Sandy.tran@med.usc.edu

    James Hu, MD

    Recruiting

  • Yale School of Medicine - Smilow Cancer Hospital - Yale - New Haven Hospital Location

    New Haven, Connecticut, 06519

    Lauren King, 203-737-4635, lauren.king@yale.edu

    Hari Deshpande, MD

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Mary Beth Wilwerding, RN, 402-354-7939, marybeth.wilwerding@nebraskacancer.com

    Kirsten M. Leu

    Recruiting

  • University of Pennsylvania - Abramson Cancer Center

    Philadelphia, Pennsylvania, 19106

    Oluseyi Ogunfidodo, MS, BSN, 215-829-7089, Oluseyi.ogunfidodo@pennmedicine.upenn.edu

    Lee Hartner, MD

    Recruiting

  • Temple University - Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    David Brown, 215-728-2769, David.Brown2@fccc.edu

    Margaret Von Mehren, MD

    Recruiting

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

    Sant P Chawla, MD, 310-500-5391, Santchawla@gmail.com

    Sant P Chawla, MD

    Recruiting

  • University of California Los Angeles (UCLA) - Santa Monica Cancer Care

    Santa Monica, California, 90404

    Jacqueline Banuelos-Murillo, 310-829-5471, JBanuelosMurillo@mednet.ucla.edu

    Arun Singh, MD

    Recruiting

Other trials in United States

Spain3 sites, 3 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

    Romina Ribas, +34 935537116/7, RRibaas@santpau.cat

    Raúl Terés Lleida, MD

    Recruiting

  • Hospital Universitari Vall Hebron

    Barcelona, 08740

    Claudia Valverde, MD, Cvalverde@vhio.net

    Claudia Valverde, MD

    Recruiting

  • Centro Integral Oncologico Clara Campal (HM CIOCC)

    Madrid, 28050

    Elena Gonzalez, MD, +34917567850, egonzalezlopez@hmhospitales.com

    Justo Ortega, MD

    Recruiting

Other trials in Spain

Germany2 sites, 2 recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

    Simone Micheel, +493363173728, simone.micheel@helios-gesundheit.de

    Daniel Pink, MD

    Recruiting

  • Universitäres Krebszentrum (UCCL)

    Leipzig, 04103

    Claudia Schmidtchen, 0341 - 97 20037, Claudia.Schmidtchen@medizin.uni-leipzig.de

    Anne-Marie Scheuble, MD

    Recruiting

Other trials in Germany

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Gagan Sran, 16472898298, gagan.sran@uhnn.ca

    Albiruni Abdul Razak, MD

    Recruiting

Other trials in Canada

France1 site, 1 recruiting

  • Centre Leon Berard

    Lyon, 69008

    Patricia Dupont, MD, +33478782828, patricia.dupont@lyon.unicancer.fr

    Jean-Yves Blay, MD

    Recruiting

Other trials in France

About this study

Official title: A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Being tested
INT230-6, Eribulin, Trabectedin, Pazopanib
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INT230-6Drug

    INT230-6 is a fixed combination of cisplatin, vinblastine and SHAO.

  • EribulinDrug

    Eribulin IV

  • TrabectedinDrug

    Trabectedin infusion

  • PazopanibDrug

    Pazopanib pill

Study groups in NCT06263231
Study groupRoleWhat they receive
INT230-6 MonotherapyExperimentalINT230-6 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.
Receives: Drug: INT230-6
US Standard of CareActive comparatorParticipants 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
Receives: Drug: Eribulin; Drug: Trabectedin; Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    To compare OS for INT230-6 vs US Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

    Measured: 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.

Secondary outcomes (2)

  1. Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma

    To compare OS for INT230-6 vs US SOC in participants with leiomyosarcoma

    Measured: 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.

  2. Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma

    To compare OS for INT230-6 vs US SOC in participants with liposarcoma

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start28 Jun 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06263231
Sponsor's protocol ID
IT-03
Acronym
INVINCIBLE-3
Status last verified
Aug 2026
First submitted
1 Feb 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: General Data Protection Regulation (GDPR) and HIPPA privacy laws will be followed for sharing of any data.

Publications

  • Billingsley KG, Burt ME, Jara E, Ginsberg RJ, Woodruff JM, Leung DH, Brennan MF. Pulmonary metastases from soft tissue sarcoma: analysis of patterns of diseases and postmetastasis survival. Ann Surg. 1999 May;229(5):602-10; discussion 610-2. doi: 10.1097/00000658-199905000-00002.

    PubMed 10235518

  • Beaver JA, Hazarika M, Mulkey F, Mushti S, Chen H, He K, Sridhara R, Goldberg KB, Chuk MK, Chi DC, Chang J, Barone A, Balasubramaniam S, Blumenthal GM, Keegan P, Pazdur R, Theoret MR. Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2018 Feb;19(2):229-239. doi: 10.1016/S1470-2045(17)30846-X. Epub 2018 Jan 18.

    PubMed 29361469

  • Bender LH, Abbate F, Walters IB. Intratumoral Administration of a Novel Cytotoxic Formulation with Strong Tissue Dispersive Properties Regresses Tumor Growth and Elicits Systemic Adaptive Immunity in In Vivo Models. Int J Mol Sci. 2020 Jun 24;21(12):4493. doi: 10.3390/ijms21124493.

    PubMed 32599852

  • Bloom AC, Bender LH, Tiwary S, Pasquet L, Clark K, Jiang T, Xia Z, Morales-Kastresana A, Jones JC, Walters I, Terabe M, Berzofsky JA. Intratumorally delivered formulation, INT230-6, containing potent anticancer agents induces protective T cell immunity and memory. Oncoimmunology. 2019 Jul 16;8(10):e1625687. doi: 10.1080/2162402X.2019.1625687. eCollection 2019.

    PubMed 31646070

  • Cassier PA, Polivka V, Judson I, Soria JC, Penel N, Marsoni S, Verweij J, Schellens JH, Morales-Barrera R, Schoffski P, Voest EE, Gomez-Roca C, Evans TR, Plummer R, Gallerani E, Kaye SB, Olmos D. Outcome of patients with sarcoma and other mesenchymal tumours participating in phase I trials: a subset analysis of a European Phase I database. Ann Oncol. 2014 Jun;25(6):1222-8. doi: 10.1093/annonc/mdu108. Epub 2014 Mar 7.

    PubMed 24608201

  • Dasari S, Tchounwou PB. Cisplatin in cancer therapy: molecular mechanisms of action. Eur J Pharmacol. 2014 Oct 5;740:364-78. doi: 10.1016/j.ejphar.2014.07.025. Epub 2014 Jul 21.

    PubMed 25058905

  • Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, Van Tine BA, Spira A, Dean A, Khokhar NZ, Park YC, Knoblauch RE, Parekh TV, Maki RG, Patel SR. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial. J Clin Oncol. 2016 Mar 10;34(8):786-93. doi: 10.1200/JCO.2015.62.4734. Epub 2015 Sep 14.

    PubMed 26371143

  • Gronchi A, Miah AB, Dei Tos AP, Abecassis N, Bajpai J, Bauer S, Biagini R, Bielack S, Blay JY, Bolle S, Bonvalot S, Boukovinas I, Bovee JVMG, Boye K, Brennan B, Brodowicz T, Buonadonna A, De Alava E, Del Muro XG, Dufresne A, Eriksson M, Fagioli F, Fedenko A, Ferraresi V, Ferrari A, Frezza AM, Gasperoni S, Gelderblom H, Gouin F, Grignani G, Haas R, Hassan AB, Hecker-Nolting S, Hindi N, Hohenberger P, Joensuu H, Jones RL, Jungels C, Jutte P, Kager L, Kasper B, Kawai A, Kopeckova K, Krakorova DA, Le Cesne A, Le Grange F, Legius E, Leithner A, Lopez-Pousa A, Martin-Broto J, Merimsky O, Messiou C, Mir O, Montemurro M, Morland B, Morosi C, Palmerini E, Pantaleo MA, Piana R, Piperno-Neumann S, Reichardt P, Rutkowski P, Safwat AA, Sangalli C, Sbaraglia M, Scheipl S, Schoffski P, Sleijfer S, Strauss D, Strauss S, Sundby Hall K, Trama A, Unk M, van de Sande MAJ, van der Graaf WTA, van Houdt WJ, Frebourg T, Casali PG, Stacchiotti S; ESMO Guidelines Committee, EURACAN and GENTURIS. Electronic address: clinicalguidelines@esmo.org. Soft tissue and visceral sarcomas: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up☆. Ann Oncol. 2021 Nov;32(11):1348-1365. doi: 10.1016/j.annonc.2021.07.006. Epub 2021 Jul 22. No abstract available.

    PubMed 34303806

  • Jones RL, Maki RG, Patel SR, Wang G, McGowan TA, Shalaby WS, Knoblauch RE, von Mehren M, Demetri GD. Safety and efficacy of trabectedin when administered in the inpatient versus outpatient setting: Clinical considerations for outpatient administration of trabectedin. Cancer. 2019 Dec 15;125(24):4435-4441. doi: 10.1002/cncr.32462. Epub 2019 Sep 10.

    PubMed 31503332

  • Lammers T, Peschke P, Kuhnlein R, Subr V, Ulbrich K, Huber P, Hennink W, Storm G. Effect of intratumoral injection on the biodistribution and the therapeutic potential of HPMA copolymer-based drug delivery systems. Neoplasia. 2006 Oct;8(10):788-95. doi: 10.1593/neo.06436.

    PubMed 17032495

  • Meyer M, Seetharam M. First-Line Therapy for Metastatic Soft Tissue Sarcoma. Curr Treat Options Oncol. 2019 Jan 24;20(1):6. doi: 10.1007/s11864-019-0606-9.

    PubMed 30675651

  • von Mehren M, Kane JM, Agulnik M, Bui MM, Carr-Ascher J, Choy E, Connelly M, Dry S, Ganjoo KN, Gonzalez RJ, Holder A, Homsi J, Keedy V, Kelly CM, Kim E, Liebner D, McCarter M, McGarry SV, Mesko NW, Meyer C, Pappo AS, Parkes AM, Petersen IA, Pollack SM, Poppe M, Riedel RF, Schuetze S, Shabason J, Sicklick JK, Spraker MB, Zimel M, Hang LE, Sundar H, Bergman MA. Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Jul;20(7):815-833. doi: 10.6004/jnccn.2022.0035.

    PubMed 35830886

  • Obeid M, Panaretakis T, Tesniere A, Joza N, Tufi R, Apetoh L, Ghiringhelli F, Zitvogel L, Kroemer G. Leveraging the immune system during chemotherapy: moving calreticulin to the cell surface converts apoptotic death from "silent" to immunogenic. Cancer Res. 2007 Sep 1;67(17):7941-4. doi: 10.1158/0008-5472.CAN-07-1622.

    PubMed 17804698

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Padhani AR, Ollivier L. The RECIST (Response Evaluation Criteria in Solid Tumors) criteria: implications for diagnostic radiologists. Br J Radiol. 2001 Nov;74(887):983-6. doi: 10.1259/bjr.74.887.740983. No abstract available.

    PubMed 11709461

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INT230-6, Eribulin and Trabectedin in people with Sarcoma,Soft Tissue, run by Intensity Therapeutics, Inc. at 17 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Spain, Germany, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kimberly Guedes, RN, M.B.A ((203) 293-4224, KGuedes@intensitytherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06263231, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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