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Flucytosine

Part 1: Dose-escalation study of T601 single-dose; Part 2: Dose-escalation study of T601 single-dose combined with 5-FC; Part 3: Dose-escalation study of T601 multiple-dose combined with 5-FC; Part 4: Extended study of T601 multiple-dose combined with 5-FC.

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.

T601

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.

T601+5-FC

Xiaomin WANG, master

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.

Preclinical studies have confirmed that the combination of T601 and 5-FC can not only enhance the anti-tumor effect, but also reduce the toxicity of T601. Considering the risks and benefits of participants of the clinical trial, the protocol design is divided into 4 parts:

Part 1: dose-escalation study of single-dose of T601 to evaluate the safety and tolerability of T601 and to determine the MTD;

Part 2: dose-escalation study of single-dose of T601 combined with predrug 5-FC, to evaluate the safety and tolerability of the treatment of single dose of T601 combined with predrug 5-FC and to determine the MTD of single dose of T601 when combing with 5-FC;

Part 3: dose-escalation study of multiple-dose of T601 combined with predrug 5-FC, to explore the safety and tolerability of the treatment of multiple dose of T601 combined with predrug 5-FC and to determine the MTD of multiple dose of T601 when combing with 5-FC, also to determine the RP2D (recommended dose for Phase II Trial);

Part 4: extending study of multiple-dose of T601 combined with predrug 5-FC, to evaluate the efficacy of the treatment of multiple-dose of T601 combined with predrug 5-FC in patients with various specific tumors and to evaluate the ORR, DCR and PFS according to the RECIST v1.1.

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

A Phase I/IIa Study to Evaluate the 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

According to NCI CTCAE 5.0., evaluate the AEs and the frequency and severity of adverse events.

According to RECIST v1.1, to assess the ORR of the patients, and to evaluate the efficacy of T601 or T601 in combination with 5-FC

According to RECIST v1.1, to assess the DCR of the patients, and to evaluate the efficacy of T601 or T601 in combination with 5-FC.

According to RECIST v1.1, to assess the PFS of the patients, and to evaluate the efficacy of T601 or T601 in combination with 5-FC.

to evaluate pharmacokinetics characteristics of T601

Blood concentration monitoring of 5-FC, 5-FU, FBAL

Spots Global Cancer Trial Database for t601

Every month we try and update this database with for t601 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for t601

Every month we try and update this database with for t601 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for t601 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.