Oncolytic Virotherapy Plus PD-1 Inhibitor for Patients With Refractory Malignant Ascites

NCT05303844 | Unknown Phase 1

• 1 other identifier: 2201249-7
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab for patients with refractory malignant ascites.

Conditions

Refractory Malignant Ascites

Outcome Measures

Primary Outcomes (3)

• Number of patient with dose-limiting toxicities (DLTs) as evaluated accordingly to CTCAE 5.0

  The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

  28 days

• Maximum tolerated dose (MTD) of intratumoral injection of H101 on at three dose levels in combination with anti-PD1 antibody.

  A MTD is determined if any cohort experiences 2 subjects with DLT's.

  28 days

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  max 24 months

Secondary Outcomes (7)

• Ascites Objective Response Rate

  max 24 months

• Objective Response Rate (ORR)

  max 24 months

• Duration of Response

  max 24 months

• Progression Free Survival

  max 24 months

• Overall survival

  max 42 months

Study Arms (1)

H101 + Tislelizumab

EXPERIMENTAL

(Dose escalation and cohort expansion) H101 administered by Intraperitoneal injection in combination with Tislelizumab administered intravenously (IV).

Drug: H101; Drug: Tislelizumab

Interventions

H101 DRUG

H101 intratumorally injection starts at day 0.

H101 + Tislelizumab

Tislelizumab DRUG

Tislelizumab will be initiated on day 1. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

H101 + Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• Pathologically diagnosed solid tumor malignancy.
• Malignant peritoneal ascites confirmed by peritoneal brush cytology.
• Failures from chemotherapy against malignant ascites.
• Cooperative Oncology Group-Status (ECOG Status) 0 or 1

You may not qualify if:

• Previous (\<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
• History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
• Prior treatment with oncolytic virotherapy.
• Radiotherapy administered less then 4 weeks prior to study treatment start.
• Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
• Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
• Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:
• history of interstitial lung disease
• Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
• known acute or chronic pancreatitis
• active tuberculosis
• any other active infection (viral, fungal or bacterial) requiring systemic therapy
• history of allogeneic tissue/solid organ transplant

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Study Officials

• Peng Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Wang, MD

CONTACT

86-21-64175590; peng_wang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 2, 2022
• Primary Completion: March 20, 2025
• Study Completion: March 20, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CN (1)