BridgeMD
A study to investigate efficacy and safety of INT230-6 compared with US standard of care in participants aged ≥ 18 years old with metastatic soft tissue sarcomas
EU CTIS ID: 2024-512423-36-00
What this study is testing
To compare OS for INT230-6 vs US SOC in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study, or consent may be provided by the participant’s legally acceptable representative (In Germany: participants must be able to provide consent to participation; legal representatives are not allowed)
- Participant (or legally acceptable representative if applicable) is capable of giving signed informed consent and provides written informed consent for the study as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Histologically proven, unresectable, locally advanced, or metastatic 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 received at least 1 line of therapy for aSTS 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 CT or MRI.
You likely can't join if
- Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.
- 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 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.
See the full eligibility criteria
Who can join
- Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study, or consent may be provided by the participant’s legally acceptable representative (In Germany: participants must be able to provide consent to participation; legal representatives are not allowed)
- Participant (or legally acceptable representative if applicable) is capable of giving signed informed consent and provides written informed consent for the study as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Histologically proven, unresectable, locally advanced, or metastatic 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 received at least 1 line of therapy for aSTS 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 CT or MRI.
- Participant must have an ECOG performance status of 0, 1 or 2
- Participant must have adequate organ function as defined by screening laboratory values that must meet the following criteria: a. Neutrophils ≥ 1500/μL (≥ 1.5× 1000000000/L). b. PT, and INR ≤ 1.5× ULN, platelets ≥ 100,000/μL (≥ 10× 1000000000/L); hemoglobin ≥ 9 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks. c. Creatinine within normal range; or calculated creatinine clearance > 50 mL/min by the Cockcroft-Gault equation. d. ALT SGOT/ AST SGPT ≤ 2.5× ULN without, and ≤ 5× ULN with hepatic metastases. e. Bilirubin ≤ 1.5× ULN (except participants with Gilbert’s syndrome, who must have total bilirubin < 3.0 mg/dL [< 52 μmol/L]). f. Creatine phosphokinase < 2.5× ULN
- 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: a. Not a 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 FSH and estradiol will be obtained to confirm childbearing potential. b. 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
- 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
What rules you out
- Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.
- 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 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 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 1 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. a. 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 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.
- History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients.
- Pregnancy Exclusion: A WOCBP who has a positive serum pregnancy test at the clinical visit, prior to treatment. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- 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.
- 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 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.
- Use of other investigational drugs (drugs not marketed for any indication) must be discontinued at least 28 days prior to study intervention administration.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.