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NeoplasmsEarly Phase 1NCT06346041

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

A Early Phase 1 study testing Oncolytic Virus injection(IDOV-SAFETM) in people with Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms
What is being tested?
Oncolytic Virus injection(IDOV-SAFETM)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
12 Apr 2024to 1 Apr 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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;
  • Subject with an active infection or developed an unexplained fever > 38.5 ° C during screening or prior to initial administration;
  • There is evidence of clinically significant immunodeficiency, such as a primary immunodeficiency state, such as severe combined immunodeficiency disease (SCID); Co-opportunistic infection;
  • At the time of screening, patients with active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or with a history of autoimmune diseases that may recur, except for the following conditions: (1)Type 1 diabetes; (2)Hypothyroidism (if controlled with hormone replacement therapy alone); (3)Controlled celiac disease; (4)Skin diseases that do not require systemic treatment;(5) Any other disease that will not recur in the absence of an external trigger;
  • Subject with an active infection or developed an unexplained fever > 38.5 ° C during screening or prior to initial administration;are receiving long-term systemic steroid (prednisone >10mg/ day or equivalent dose of the same drug) or any other form of immunosuppressant therapy within 14 days prior to initial treatment; Treatment with topical, ocular, intra-articular, intranasal, and inhalation corticosteroids is excluded; Short-term use of corticosteroids (≤10mg equivalent dose of prednisone) for preventive treatment (e.g. prevention of contrast agent allergy);
  • Patients with received allogeneic tissue or solid organ transplantation;
  • Other diseases or abnormalities assessed by the investigator as unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ning Li, MD contact

15601395554

lining@cicams.ac.cn

Shuhang Wang, PhD contact

13581809307

wangshuhang@cicams.ac.cn

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing

    Ning Li, MD, 15601395554, lining@cicams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study of Evaluating the Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors

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.

Read the detailed description

The study is a single agent dose escalation which will use an accelerated and "3+3" design to evaluate escalating doses of IDOV-SAFETM.Total enrollment will depend on the toxicities and/or activity observed, with approximately 13-19 evaluable participants enrolled. A Dose-Limiting Toxicity (DLT) observation period of 3weeks was established before the entry of the first patient at the next dose level. After all subjects in the current dose group have completed the DLT observation period, the administration of the next dose group can only be started if the condition of dose escalation is met.

Conditions
Neoplasms
Being tested
Oncolytic Virus injection(IDOV-SAFETM)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oncolytic Virus injection(IDOV-SAFETM)Biological

    Administered by intravenous injection as single agent.

Study groups in NCT06346041
Study groupRoleWhat they receive
Oncolytic Virus injection(IDOV-SAFETM)ExperimentalIntravenous 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
Receives: Biological: Oncolytic Virus injection(IDOV-SAFETM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Within day 21 after administration

  2. Incidence of adverse events and severe adverse events

    Graded according to the NCI CTCAE version 5.0

    Measured: Within day 85 after administration

  3. MTD/MFD

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

    Measured: Within day 21 after administration

Secondary outcomes (7)

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

    1. The level of (non-essential) viral DNA in tumor tissue;
    2. Levels of viral DNA in blood, saliva and urine

    Measured: Up to 2 days

  2. Immunogenicity of IDOV-SAFETM

    Neutralizing antibody titer

    Measured: Up to 85 days

  3. ORR

    The sum of the proportion of subjects with CR or PR

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

  4. DCR

    The sum of the proportion of subjects with CR 、PR or SD

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

  5. DOR

    The time between the start of the first assessment of the tumor as CR or PR and the second assessment as PD(Progressive Disease) or death from any cause

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

  6. PFS

    The time, measured in days, from the date of first treatment to disease progression or death from any cause. Disease progression and death were measured in terms of preoccurrence. Progression included radiographic progression or clinical progression as assessed by the investigator.

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

  7. OS

    The time from the date of first treatment to death from any cause, measured in days

    Measured: Up to death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start12 Apr 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06346041
Sponsor's protocol ID
HJG-IDOV-SAFE-LYSW
Status last verified
Feb 2025
First submitted
12 Mar 2024
Last updated
4 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Oncolytic Virus injection(IDOV-SAFETM) in people with Neoplasms, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ning Li, MD (15601395554, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLT) (time frame: Within day 21 after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06346041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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