A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

NCT06200376 | Unknown Phase 1

• 1 other identifier: MVR-T3011-ES-EC61-MA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer.

Conditions

Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• Adverse event

  To evaluate the safety of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites

  28 days after EOT

Secondary Outcomes (5)

• Overall response rate (ORR)

  From 4th dosing to disease progression, consent withdraw, death or end of study, assessed up to 24 months

• Disease control rate (DCR)

  From 4th dosing to disease progression, consent withdraw, death or end of study, assessed up to 24 months

• Time to onset of therapeutic paracentesis

  From 4th dosing to disease progression, consent withdraw, death or end of study, assessed up to 24 months

• Overall survival (OS)

  Up to 24 months

• Quality of life questionnaire (QLQ-C30)

  Up to 24 months

Study Arms (1)

T3011

EXPERIMENTAL

Drug: T3011

Interventions

T3011 DRUG

T3011 will be administered intraperitoneally twice a week.

T3011

Eligibility Criteria

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

You may qualify if:

• Male or female age ≥ 18 years and ≤ 75 years at the time of informed consent.
• Histologically or cytologically confirmed advanced unresectable or metastatic colorectal cancer;
• Anticipated life expectancy ≥3 months
• Associated with medium amount of malignant ascites (defined as the amount of ascites ≥3cm by B ultrasonography in lying position accompanied by clinical symptomes like abdonimal distension and cytology tests possitive for tumor in ascites); No paracentesis performed with 28 days before first dosing; and the ascites can not be controlled by SOC according to PI judgement.
• ECOG performance status 0-2 (including threshold);
• Weight ≥40kg
• Hematology:
• White blood cell (WBC) ≥ 3.0×10\^9/L;
• Neutrophil (ANC) ≥ 1.5×10\^9/L;
• Platelet (PLT) ≥ 75×10\^9/L;
• Hemoglobin (Hb) ≥ 8.0g/dL
• Hepatic and renal function:
• Total bilirubin ≤ 1.5 × ULN;
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN for patient without liver metastasis, ≤ 5 × ULN for patients with liver metastasis;
• Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation;

You may not qualify if:

• Previously diagnosed with decompensated cirrhosis, and with portal vein and branch involvement or cancer embolus;
• Pregnant or lactating, or plan to pregnant or give birth during the trial;
• Persistent or active infection that are not controlled by treatment including but not limited to: active tuberculosis, non-negative HIV antibody, HBsAg positive and HBV DNA ≥LOQ, HCV ab positive and HCV DNA ≥LOQ;
• Patients with imageological confirmed brain metastasis or brain metastasis history (except patients with stable disease within 3 months before screening and not require systemic glucorticoid therapy according to PI), pia meningeal disease, spinal cord compression;
• Autoimmune disease or related symptoms, or previously suffered from autoimmune disease;
• History of splenectomy or organ transplantation;
• Prior treatment with Oncolytic virus (OV) (including but not be limited to T-VEC, T3011), gene therapy, cellular therapy or tumor vaccines;
• Requires oral or intravenous therapy against herpes virus (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs (eg. external use) are allowed;
• Patients are scheduled to receive other therapy against malignant ascites (including but not limited to chemotherapy, target therapy, immunotherapy), and the best supportive treatment for malignant ascites is permitted (e.g., albumin supplements, etc.);
• Patients with a known psychiatric disorder that would interfere with cooperation with the requirements of the trial;
• History of narcotics (recreational use) and substance abuse (including alcohol) within 1 year prior to signing informed consent;
• History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody or any excipients for T3011;
• History or evidence of high risk cardiovascular disease, including but not limited to:
• Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, QT interval corrected using the Fridericia formula (QTcF) ≥ 450 msec (male) or ≥ 470 msec (female);
• Acute myocardial infarction, unstable angina pectoris, or stroke occurred within 6 months before the first administration of the experimental drug;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

Central Study Contacts

Meng Qiu, MD

CONTACT

028-85423203; qiumeng33@hotmail.com

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: Prof.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: January 11, 2024
• Study Start: September 28, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Locations

CN (1)