Vinblastine sulfate; Cisplatin for Dedifferentiated liposarcoma | Myxoid liposarcoma | Round cell liposarcoma | Pleomorphic liposarcoma | Undifferentiated pleomorphic sarcoma | Leiomyosarcoma (non-uterine)

Inclusion criteria

• {"criterion_text":"- 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)\n- 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.\n- 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.\n- 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\n- Participant must have measurable disease per RECIST 1.1 criteria\n- Participant must have at least 1 target tumor suitable for injection using routine image guidance ≥ 2 cm measurable by CT or MRI.\n- Participant must have an ECOG performance status of 0, 1 or 2\n- 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\n- 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\n- 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"}

Exclusion criteria

• {"criterion_text":"- Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.\n- 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.\n- 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.\n- 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.\n- Participants actively receiving therapy with strong Cytochrome P450 3A4 isoenzyme (CYP3A4) inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil).\n- 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.\n- 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.\n- 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.\n- Use of other investigational drugs (drugs not marketed for any indication) within 28 days prior to study intervention administration.\n- Received a live vaccine within 6 weeks of first dose of study intervention.\n- 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.\n- History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients.\n- 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.\n- 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.\n- 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.\n- 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.\n- 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.\n- Use of other investigational drugs (drugs not marketed for any indication) must be discontinued at least 28 days prior to study intervention administration.\n- Participants who require uninterrupted anticoagulants of any type or is on daily aspirin therapy or NSAIDS.\n- 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)."}

Primary endpoints

• {"endpoint_text":"- Overall survival (OS), as defined as the time from date of randomization to date of death due to any cause.","definition_or_measurement_approach":"OS defined as the time from date of randomization to date of death due to any cause."}

Secondary endpoints

• {"endpoint_text":"- OS as defined as the time from date of randomization to date of death due to any cause.\n- Exploratory: The incidence of grade 3 or higher drug-related AEs will be assessed by the incidence of > grade 3 drug-related AEs according to the CTCAE (v6.0).\n- Exploratory: Change from baseline in the global health status/QoL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months).\n- Exploratory: Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment.\n- Exploratory: Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months).\n- Exploratory: Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30.\n- Exploratory: Changes in safety parameters including laboratory test results, ECOG performance status, etc.","definition_or_measurement_approach":"OS: time from randomization to death due to any cause. Incidence of grade ≥3 drug-related AEs assessed per CTCAE v6.0. QoL change assessed by EORTC QLQ-C30 (global health status/QoL scale) up to 24 months. Definitive deterioration defined as ≥10% worsening from baseline with no subsequent improvement above threshold or until death. Safety parameters include laboratory tests and ECOG performance status changes."}

Other endpoints

• {"endpoint_text":"- Exploratory: The incidence of grade 3 or higher drug-related AEs will be assessed by the incidence of > grade 3 drug-related AEs according to the CTCAE (v6.0).\n- Exploratory: Change from baseline in the global health status/QoL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months).\n- Exploratory: Summary of composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment.\n- Exploratory: Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQC30 (Time Frame: Up to 24 months).\n- Exploratory: Definitive deterioration: time from date of randomization to date of event, defined as at least a 10% worsening from baseline with no later improvement above this threshold observed during the course of the treatment or until death due to any cause, in the global health status/QOL scale score of EORTC QLQ-C30.\n- Exploratory: Changes in safety parameters including laboratory test results, ECOG performance status, etc.","definition_or_measurement_approach":"Exploratory endpoints assessed as specified: CTCAE v6.0 for AE grading; EORTC QLQ-C30 for QoL measures (global health status/QoL scale) up to 24 months; composite domain/index summaries at each assessment; time-to-event and change-from-baseline definitions as described above; safety parameters via laboratory tests and ECOG."}

Poland

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

26-11-2024

Processing Time Days

99

Number Of Sites

4

Number Of Participants

18

France

Earliest CTIS Part Ii Submission Date

21-08-2024

Latest Decision Or Authorization Date

07-11-2024

Processing Time Days

78

Number Of Sites

4

Number Of Participants

26

Italy

Earliest CTIS Part Ii Submission Date

29-08-2024

Latest Decision Or Authorization Date

26-11-2024

Processing Time Days

89

Number Of Sites

7

Number Of Participants

22

Germany

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

13-11-2024

Processing Time Days

114

Number Of Sites

3

Number Of Participants

27

Spain

Earliest CTIS Part Ii Submission Date

16-08-2024

Latest Decision Or Authorization Date

31-01-2025

Processing Time Days

168

Number Of Sites

12

Number Of Participants

25

Primary sponsor

Full Name

Intensity Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Premier Research Group S.L.

Responsibilities

Sponsor duties codes: 1,10,11,12,15 (Medical monitoring),2,3,5,6,8

Third parties

• {"country":"Spain","full_name":"Premier Research Group S.L.","duties_or_roles":"Sponsor duties codes: 1,10,11,12,15 (Medical monitoring),2,3,5,6,8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"LabConnect GmbH","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"Sponsor duties code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Ascopharm GmbH","duties_or_roles":"Sponsor duties code: 15 (Patients´expenses reimbursement in Germany, Spain, Poland and France.)","organisation_type":"Pharmaceutical company"}