Treatment of advanced solid tumors with IDOV-SAFE

A Phase I Clinical Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors

This study is testing a new treatment called IDOV-SAFE to see if it can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT06718946 on ClinicalTrials.gov

What this trial studies

This open-label, dose escalation study evaluates the safety and efficacy of intravenous IDOV-SAFE in patients with advanced solid tumors who have not responded to standard treatments. The trial will enroll 17-32 patients in China, administering escalating doses of the treatment to determine the maximum tolerated dose and assess pharmacokinetics and immunogenicity. Each patient will receive the treatment on the first day of a 21-day cycle, with follow-up assessments to guide further dosing. The study aims to gather critical data on the drug's safety profile and potential therapeutic effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with measurable advanced solid tumors that have failed previous treatments.

Not a fit: Patients with solid tumors that are not advanced or those who have not failed standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: from 18 to 75 years old.
2. At the time of screening, the patient had at least one measurable target lesion.
3. Patients with advanced solid tumors who have failed standard therapy during screening.
4. When screening, the ECOG score of physical strength score is 0 or 1.
5. Life expectancy assessed by the investigator at the time of screening was ≥3 months.
6. Subject has qualified organ function at baseline:

   a) Bone marrow function (no growth factor support therapy or component transfusion within 14 days prior to screening) : i. Neutrophil absolute value (ANC) ≥1.5×10\^9/L; ii. Hemoglobin (HB) ≥90g/L; iii. Platelet count (PLT) ≥75×10\^9/L; b) Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), total bilirubin (TBIL) ≤1.5 times ULN (ALT and AST≤5 times ULN, TBIL≤3 times ULN for liver metastasis or hepatocellular carcinoma); c) Renal function: serum creatinine ≤ULN or creatinine clearance ≥80mL/min;
7. Fertile female subjects must have negative blood beta-HCG test results within 7 days prior to enrollment.
8. Subjects must agree to use highly effective contraception for at least 90 days from the start of the ICF to the end of the study.
9. Be fully informed of this study and voluntarily sign ICF.

Exclusion Criteria:

1. Asymptomatic brain metastases such as untreated ones at the time of screening; Subjects with symptomatic central nervous system (CNS) metastatic or cancerous meningitis; Or there was other evidence of uncontrolled central nervous system or meningeal metastases in subjects who were judged by the investigator to be unsuitable for enrollment.
2. Prior to enrollment, there was severe chronic or active infection: active hepatitis B (HbsAg positive, HBV DNA test value greater than the upper limit of normal); Active hepatitis C (those with positive anti-HCV antibodies are further tested positive for HCV RNA); A known history of immunodeficiency virus (HIV) disease or a positive HIV antibody test; Other conditions requiring systemic anti-infective treatment in the 4 weeks prior to initial use of the investigational drug include, but are not limited to, hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
3. At the time of screening, patients had a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or were receiving long-term systemic steroids (prednisone \>10mg/ day or equivalent doses of the same drug) or any other form of immunosuppressant therapy within 4 weeks prior to the first use of the study drug.
4. Patients with received allogeneic tissue or solid organ transplantation.
5. There is evidence of clinically significant immunodeficiency, such as primary immunodeficiency status, such as severe combined immunodeficiency disease (SCID); Combined with opportunistic infections.
6. Anticoagulants or antiplatelet drugs should be used before injection and should not be interrupted, including: aspirin should not be stopped within 7 days before injection; Coumarin that cannot be stopped within 7 days prior to injection; Direct thrombin inhibitors (such as dabigatrun) or direct factor Xa inhibitors (such as rivaroxaban, apixaban, and neperoxaban) that cannot be discontinued within 4 days prior to injection; Low molecular weight heparin (LMWH) should not be stopped within 24 hours before injection, and ordinary heparin (UFH) should not be stopped more than 4 hours before injection.
7. Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: congestive heart failure ≥II heart function grade of the New York Heart Association (NYHA); Left ventricular ejection fraction (LVEF) \<50%; QT interval (QTcF) \>470ms as corrected by the Fridericia method or prolonged QT interval syndrome; Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before first administration; The presence of uncontrolled hypertension (systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg). Subjects with a history of hypertension are admitted to the study if their blood pressure is controlled and maintained below this standard with antihypertensive therapy.
8. Patients with received treatment with other methods, including but not limited to chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first use of the investigational drug.
9. Other diseases or abnormalities assessed by the investigator as unsuitable for participation in the study.
10. Vaccination against smallpox or monkeypox within 10 years.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Hongxia Wang, PhD — Fudan University
• Study coordinator: Jianhua Chen, PhD

Conditions Advanced Malignant Solid Tumor