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

Inclusion Criteria:

1. Participant is of any sex and must be ≥ 18 years old and provide written informedconsent to participate in the study. Type of Participant and Disease Characteristics

2. Histologically proven, unresectable, locally advanced, or metastatic Soft TissueSarcoma (STS) only of the following subtypes: liposarcoma (dedifferentiated, myxoid,round cell or pleomorphic), leiomyosarcoma, and undifferentiated pleomorphicsarcoma. Participant must have a pathology report indicating the diagnosis of theirSTS.

3. Participant must have received at least 1 line of therapy for a STS and must haveprogressed following anthracycline-based or alternative standard therapies, exceptif medically contraindicated or refused by participant. Participant cannot havereceived more than 2 prior regiments for unresectable, locally advanced ormetastatic STS.

4. Participant must have measurable disease per RECIST 1.1 criteria.

5. Participant must have at least 1 target tumor suitable for injection using routineimage guidance ≥ 2 cm measurable by Computed Tomography (CT) or Magnetic ResonanceImaging (MRI).

6. Participant must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0, 1 or 2 (see Section 11.7).

7. Participant must have adequate organ function as defined by screening laboratoryvalues that must meet the following criteria:

8. Neutrophils ≥ 1500/μL (≥ 1.5× 109/L).

9. Prothrombin Time (PT), and International Normalized Ratio (INR) ≤ 1.5× UpperLimit of Normal (ULN), platelets ≥ 100,000/μL (≥ 10× 109/L); hemoglobin ≥ 9g/dL. Criteria must be met without erythropoietin dependency and without packedred blood cell transfusion within the last 2 weeks.

10. Creatinine within normal range; or calculated creatinine clearance > 50 mL/minby the Cockcroft-Gault equation.

11. 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.

12. Bilirubin ≤ 1.5× ULN (except participants with Gilbert's syndrome, who musthave total bilirubin < 3.0 mg/dL [< 52 µmol/L]).

13. Creatine phosphokinase < 2.5× ULN Sex and Contraceptive/Barrier Requirements

14. A female participant is eligible to participate if she is not pregnant (asdemonstrated by pregnancy testing prior to each treatment; performed at leastmonthly), not breastfeeding, and at least 1 of the following conditions applies:

15. Not a Woman of Childbearing Potential (WOCBP). Women of non-childbearingpotential are defined as women with functioning ovaries with a documentedhistory of tubal ligation or hysterectomy or females who are post menopausal,as defined by 12 months of spontaneous amenorrhea with an appropriate clinicalprofile, e.g., age appropriate, > 45 years, in the absence of hormonereplacement therapy. In questionable cases, a blood sample for FollicleStimulating Hormone (FSH) and estradiol will be obtained to confirmchildbearing potential.

16. A WOCBP who may become pregnant or who is sexually active with a partner andwho could become pregnant agrees to use a highly effective form ofcontraception during the study and for at least 7 months after the end of studyintervention (see Section 11.5.2 for highly effective methods ofcontraception).

17. Male participants with female partners of childbearing potential must agree to usecontraception and refrain from sperm donation during the study and for 6 monthsafter the end of study intervention (Section 11.5.2.2).

Exclusion Criteria:

Informed Consent:

1. Adult participants who lack capacity to consent without a legally authorizedrepresentative will be excluded from this study. Medical Conditions:

2. Prior primary or metastatic brain or meningeal tumors unless clinically andradiographically stable as well as off-steroid therapy for at least 2 months.

3. History of severe hypersensitivity reactions to US SOC agents and vinblastine orcisplatin or other products of the same class and their excipients.

4. Histologically proven, unresectable, locally advanced or metastatic STS subtypesother than those specified, for example excluded subtypes include liposarcoma (welldifferentiated), desmoid or dermatofibrosarcoma protuberans.

5. Other prior malignancy, except for adequately treated basal or squamous cell skincancer or superficial bladder cancer, or any other cancer from which the participanthas been disease-free for at least 2 years.

6. Underlying medical condition that, in the investigator's opinion, will make theadministration of study intervention hazardous or obscure the interpretation oftoxicity determination or Adverse Events (AEs).

7. Concurrent medical condition requiring the use of immunosuppressive medications, orsystemic corticosteroids (topical steroids are permitted); systemic corticosteroidsmust be discontinued at least 4 weeks prior to dosing. Inhaled or intranasal corticosteroids (with minimal systemic absorption) may becontinued if the participant is on a stable dose. Non-absorbed intra-articularsteroid injections will be permitted. Use of steroids as prophylactic treatment forparticipants with contrast allergies to diagnostic imaging contrast dyes will bepermitted.

8. Participants who require uninterrupted anticoagulants of any type or is on dailyaspirin therapy or NSAIDS.

9. Known significant chronic liver disease, such as cirrhosis or active hepatitis (potential participants who test positive for hepatitis B surface antigen orhepatitis C antibodies are allowed provided they do not have active diseaserequiring antiviral therapy).

10. Myocardial infarction within 6 months before enrollment, New York Heart AssociationClass II or greater heart failure, uncontrolled angina, severe uncontrolledventricular arrhythmias, clinically significant pericardial disease orelectrocardiographic evidence of acute ischemic or active conduction systemabnormalities.

11. Uncontrolled intercurrent illness including, but not limited to, poorly controlledhypertension or diabetes, ongoing active infection or psychiatric illness/socialsituation that may potentially impair the participant's compliance with studyprocedures.

12. Participants with a Corrected QT interval (QTc) of >450 ms for men and >470 ms forwomen, or with a history of serum electrolyte abnormalities known to prolong the QTinterval such hypocalcemia, hypokalemia, and hypomagnesemia, or a family or personalhistory of congenital long QT syndrome.

13. Participants actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole,clarithromycin, telithromycin, ritonavir, mibefradil).

14. Participants actively receiving therapy with medications that have the potential toprolong the QT interval and the treatment cannot be either discontinued or switchedto a different medication prior to starting study intervention. Prior/Concomitant Therapy

15. Prior chemotherapy or immunotherapy (tumor vaccine, cytokine or growth factor givento control the cancer: systemic or IT) must have been completed at least 4 weeksprior to dosing (with the exception of kinase inhibitors or other short half-lifedrugs, a 2-week washout is acceptable prior to treatment) and all AEs have eitherreturned to baseline or stabilized. Note: participants who have received priorplatinum therapy are eligible irrespective of their response. If participant hadreceived one of the 3 US SOC study regimens prior to enrollment, that previous USSOC cannot be assigned in this study.

16. Prior systemic radiation therapy (IV, intrahepatic or oral) completed at least 4weeks prior to study intervention administration. Prior focal radiotherapy completedat least 2 weeks prior to study intervention administration. a. Prior major treatment-related surgery completed at least 4 weeks prior to studyintervention administration.

17. Use of other investigational drugs (drugs not marketed for any indication) within 28days prior to study intervention administration.

18. Received a live vaccine within 6 weeks of first dose of study intervention.

19. 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 lessthan 3 weeks ahead of a tumor assessment. Other Exclusion Criteria

20. Pregnancy Exclusion: A WOCBP who has a positive pregnancy test (e.g., within 72hours) prior to treatment. If a urine test is positive or cannot be confirmed asnegative, a serum pregnancy test will be required.