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Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors

NCT04226066 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-12-07

No results posted yet for this study

Summary

This open, dose-escalation and extended PhI/IIa clinical trial aims to evaluate the safety, tolerability of T601 as a single-agent as well as combined with prodrug 5-FC to treat patients with advanced malignant solid tumors and to explore the pharmacokinetic characteristics of T601, 5-FC, 5-FU, FBAL, which includes PhI study of dose-escalation study and Ph IIa study of extending study.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

BIOLOGICAL

T601

Part1: T601 is injected once (Day1). Dose range: 1E+7, 3E+7, 1E+8, 3E+8, 1E+9pfu.Trial cycle: Day1-21. For part1, 3+3 dose-escalation. After all patients of one dosage finished DLT evaluation, investigator judged that patients can benefit from treatment and no intolerable toxicity occurred, patients could receive maintenance treatment, and treatment plan is same as Cycle 1.

COMBINATION_PRODUCT

T601+5-FC

Part2: T601 is injected once (Day1). Dose range: MTD-2, MTD-1 and MTD of Part1. 5-FC is taken on Day5-18 for 14 consecutive days. Trial cycle: Day1-28. Part3: T601 is injected 3 times (Day1, 8, 15). Dose range: MTD-1 and MTD, or MTD-2 and MTD-1 of Part2. 5-FC is taken on Day5-7, Day12-14 and Day19-32. Trial cycle: Day1-46. Part4: Protocol revised based on results of Part1-Part3. Preliminary plan: 30 patients with gastric cancer, pancreatic cancer and hepatocellular cancer who have failed standard therapeutic options are enrolled (10 patients for each indication). Treatment plan is same as Part3. For part2 and part3, 3+3 dose-escalation. After all patients of one dosage finished DLT evaluation, investigator judged that patients can benefit from treatment and no intolerable toxicity occurred, patients could receive maintenance treatment, and treatment plan is same as Cycle 1.

Sponsors & Collaborators

  • Tasly Tianjin Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2021-05-31
Completion
2022-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04226066 on ClinicalTrials.gov