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NCT Number: NCT07136285

Olvi-Vec Combined With Platinum Plus Etoposide Therapy in Patients With Late Phase SCLC

Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhejiang Provincial People's Hospital, Hangzhou, China

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About this study

Olvi-Vec is a genetic engineering modification of acne virus. GLP preclinical studies include the safety, pharmacology, and toxicology have been completed. Clinical studies exploring efficacy and safety in different types of tumor are ongoing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and voluntarily sign an informed consent form.
  • Age ≥ 18 years old, gender not limited.
  • Small cell lung cancer confirmed by organization or cytology.
  • After receiving platinum based chemotherapy regimens and/or immunotherapy, platinum based chemotherapy regimens and/or anlotinib, and other recommended treatments according to guidelines, disease progression or recurrence has occurred.
  • There should be at least one measurable target lesion during the baseline period, according to RECIST 1.1 (if a lesion that has received radiation therapy has obvious evidence of disease progression after radiation therapy, it can be used as a target lesion).
  • ECOG physical condition score 0 or 1.
  • Have sufficient bone marrow, liver and kidney organ function-

Exclusion criteria

  • Compound small cell lung cancer and transformed small cell lung cancer.
  • Patients with brain metastases and neurological symptoms; Note: Subjects with previous imaging evidence of brain metastases who have undergone local treatment (such as radiotherapy or surgery) for intracranial metastases and have stable lesions for more than 28 days without symptoms can be enrolled.
  • Other primary malignant tumors other than small cell lung cancer (excluding non melanoma skin cancer, breast cancer in situ, cervical cancer in situ, and superficial bladder cancer, or other cancers that have been effectively controlled in the past three years and have no evidence of disease recurrence) were previously or currently combined.
  • Clinically significant cardiovascular diseases At the beginning of the study treatment, the toxicity associated with previous anti-tumor treatments did not recover to ≤ CTCAE grade 1, except for hair loss and peripheral neurotoxicity of CTCAE grade 2.
  • Known HIV infection (HIV antibody positive), active hepatitis B and C patients.
  • Receive chemotherapy, targeted therapy, radiotherapy, and biological therapy, with less than 4 weeks since the first administration in this study; Or have received local radiotherapy within 2 weeks.
  • Having undergone major surgery or significant traumatic injury within 28 days prior to the first administration of the investigational drug -

Treatment and study plan

Olvi-Vec

Drug

Olvi-Vec will be administered to patient for 3 days during C1

platinum (cisplatin or carboplatin)

Drug

After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Platinum (Carboplatin or Cisplatin)will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.

etoposide

Drug

After completing the first cycle of treatment of Olvi-Vec (+21 days after the last dose), Etoposide will be administrated on D1,D2 and D3 each 21 days (dosage according to the label) from Cycle 2 until disease progression or intolerable toxicity occurred.

Primary outcomes

  1. Evaluate safety of Olvi-Vec in patients from day 1 to end of study

    Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

    Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0

Secondary outcomes

  1. Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1

    Time frame: Day 1 to day 25 of treatment cycle 1

    Olvi-Vec related Grade 3 or higher adverse events (AEs) which meets DLT criteria.

  2. Objective Response Rate (ORR)

    Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

    ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.

  3. Disease control rate (DCR)

    Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

    DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1

  4. Progression free survival (PFS)

    Time frame: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.

    PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first)

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Chen

CONTACT

[email protected]

+8613801955339

Helena zhu

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.

Industry

Collaborators

  • Genelux Corporation

Registry information

Official study title

PIb/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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