Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors

NCT06346041 | Recruiting Early Phase 1

• 1 other identifier: HJG-IDOV-SAFE-LYSW
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicities (DLT)

  Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions

  Within day 21 after administration

• Incidence of adverse events and severe adverse events

  Graded according to the NCI CTCAE version 5.0

  Within day 85 after administration

• MTD/MFD

  To explore the maximum tolerated dose (MTD) or maximum administration dose (MFD) of IDOV-SAFETM in patients with advanced solid tumors.

  Within day 21 after administration

Secondary Outcomes (7)

• The Pharmacokinetics characteristics of IDOV-SAFETM((biological distribution and viral expulsion))

  Up to 2 days

• Immunogenicity of IDOV-SAFETM

  Up to 85 days

• ORR

  Every 6 weeks (±7 days) after initial administration and every 12 weeks (±7 days) after 1 year

• DCR

  Every 6 weeks (±7 days) after initial administration and every 12 weeks (±7 days) after 1 year

• DOR

  Every 6 weeks (±7 days) after initial administration and every 12 weeks (±7 days) after 1 year

Study Arms (1)

Oncolytic Virus injection(IDOV-SAFETM)

EXPERIMENTAL

Intravenous administration of IDOV-SAFETM as single agent for patients with advanced solid tumors. Dose cohorts: 1x10\^9 pfu、3x10\^9 pfu、1x10\^10 pfu and 3x10\^10 pfu

Biological: Oncolytic Virus injection(IDOV-SAFETM)

Interventions

Oncolytic Virus injection(IDOV-SAFETM) BIOLOGICAL

Administered by intravenous injection as single agent.

Oncolytic Virus injection(IDOV-SAFETM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign a written informed consent;
• Male and female, ≥18 years old and ≤75 years old;
• Histologically or cytologically confirmed advanced malignant solid tumors that do not respond to standard treatment (disease progression or treatment intolerance after treatment) or currently lack effective standard treatment (including but not limited to advanced MSS colorectal cancer);
• ECOG physical status score 0\~1;
• Expected survival ≥3 months;
• At least one evaluable lesion according to the solid tumor response criteria (RECIST version 1.1). Note: If the only evaluable disease site has previously received radiation therapy, it can be considered an evaluable lesion after determining disease progression;
• Major organ and bone marrow functions meet the following criteria within 7 days prior to initial dosing:
• Blood routine: neutrophils ≥1.5×109/L, platelets \> 100×109/L, hemoglobin ≥90g/L(no blood transfusion, no supportive treatment with G-CSF and other drugs within 2 weeks before screening);
• Liver function: General patients: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)≤3× upper limit of normal; Total bilirubin ≤1.5× upper limit of normal value; Patients with liver metastasis: ALT and/or AST ≤5× upper limit of normal;
• Renal function: serum creatinine (Cr)≤1.5× upper limit of normal value or creatinine clearance CCr≥60ml/min(using Cockcroft-Gault formula: The Ccr (ml/min) = \[(140 - age) \* weight kg \* F\] / \[serum creatinine (mg/dl) x 72\] (F = 1 male, the female F = 0.85).
• Coagulation function: prothrombin time (PT)≤ 1.5×ULN or International Normalized ratio (INR)≤ 1.5×ULN, and activated partial thromboplastin time (APTT)≤ 1.5×ULN;
• The blood pregnancy results of fertile female subjects within 7 days prior to the first dosing must be negative. Female subjects were willing to use highly effective contraception during the trial and for at least 90 days after the last dose of the trial drug. Male subjects were willing to use highly effective contraception during the trial and for at least 90 days after the last dose of the trial drug.

You may not qualify if:

• Severe systemic reactions or side effects due to prior smallpox vaccination;
• Patients with known to be allergic to the test drug or its excipients;
• Patients with a history of other tumors within 5 years prior to screening, excluding effectively resected cervical carcinoma in situ, low-risk gastrointestinal stromal tumor, breast cancer, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and papillary thyroid carcinoma;
• Patients with untreated symptomatic central nervous system metastases (CNS) who meet one of the following criteria can be enrolled:
• CNS metastasis is asymptomatic and does not require treatment;
• The CNS metastases have been treated, neurological symptoms have returned to baseline (except for treatment-related residual signs or symptoms), glucocorticoids have been discontinued for at least 2 weeks prior to randomization, and imaging studies within 28 days prior to randomization suggest that the CNS lesions are radiographically stable.
• Pial metastasis;
• Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• Previous acceptance of oncolytic viruses, stem cells or gene therapy products;
• Patients with received systemic antitumor therapy, including but not limited to chemotherapy, endocrine therapy, and immunotherapy, within 4 weeks before the first dose; Oral small-molecule targeted drugs are administered 2 weeks before the first dose or within 5 half-lives of the drug (whichever is longer); Palliative radiotherapy within 14 days before the first dose; Participated in clinical trials of other antitumor drugs within 4 weeks; Received any Chinese herbal medicine or proprietary Chinese medicine for any anti-tumor indication within 2 weeks prior to initial administration;
• The adverse reactions of previous anti-tumor therapy have not returned to CTCAE 5.0 grade evaluation ≤ Class 1 (except toxicity judged by the investigator to have no safety risk);
• Patients with received surgery or interventional treatment (excluding tumor biopsy, puncture, etc.) or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose;
• Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: congestive heart failure ≥ Class II 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 the first treatment; Hypertension poorly controlled by standard treatment (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
• Patients with a history of exfoliated skin that requires systemic treatment (such as eczema or ectopic dermatitis);
• 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;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ning Li, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, MD

CONTACT

15601395554; lining@cicams.ac.cn

Shuhang Wang, PhD

CONTACT

13581809307; wangshuhang@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 3, 2024
• Study Start: April 12, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)