Advanced Malignant Solid TumorsPhase 1/2NCT04226066
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 1/2 study testing T601 and T601+5-FC in people with Advanced Malignant Solid Tumors, run by Tasly Tianjin Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- T601 and T601+5-FC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesChina
- Study dates
- 20 Nov 2019to 31 May 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years and ≤ 75;
- Part1-Part3: histological or cytological confirmed advanced malignant solid tumors patients who have received standard therapeutic options in previous treatment and now there's no standard therapy available; Part4: patients with gastric cancer, pancreatic cancer and hepatocellular carcinoma will be enrolled in Phase IIa Clinical Trial;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Expected survival of at least 3 months;
- Patient presenting with at least one evaluable lesion according to RECIST 1.1 in Part1-Part3; patient presenting with at least one measurable lesion according to RECIST 1.1 in Part4;
- Adequate blood system function, liver function and kidney function:
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- ANC≥1.5×109/L，PLT≥80×109/L，Hb≥90 g/L;
- TBIL≤1.5×ULN，ALT≤3×ULN，AST≤3×ULN (Patients with liver metastasis or liver cancer ALT≤5×ULN，AST≤5×ULN);
- Cr≤1.5×ULN, creatinine clearance>50mL/min (calculate according to Cockcroft-Gault Formula);
- APTT≤1.5×ULN，PT≤1.5×ULN，INR≤1.5×ULN.
- Fertile eligible patients (male and female) must agree to use highly effective method of contraception (i.e. hormone or barrier method or abstinence) during clinical trial and for a minimum of 12 weeks after the last administration of T601; negative blood pregnancy test for women of childbearing potential (WOCBP) within 7 days before enrollment ;
- Give informed consent to the study prior to the test and voluntarily sign a written informed consent.
Who cannot join
- Received chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to T601 treatment initiation, except for the following items:
- Received nitrosourea or mitomycin C within 6 weeks before T601 treatment initiation; Orally taken fluorouracil and small-molecule targeted drugs within 2 weeks before T601 treatment initiation or within 5 half-lives of the above drugs (subject to whichever is longer); Received the Chinese medicines with anti-tumor indications within 2 weeks before T601 treatment initiation;
- Prior participation in another clinical study involving an IMP with last intake within 4 weeks prior to T601 treatment initiation;
- Received major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks prior to T601 treatment initiation;
- The adverse reactions of previous anti-tumor therapy have not yet returned to CTCAE 5.0 ≤1 (except the toxicity that the investigator judged as no safety risk, such as hair loss);
- With clinical symptoms of brain metastasis, spinal cord compression, and cancerous meningitis, or other evidence indicates that the metastasis of the patient's brain and spinal cord has not been controlled, and the investigator judged that the patient was not suitable for inclusion. Patients with clinical symptoms suspected of cerebral or pia mater disease should be excluded by CT/MRI examination;
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- Uncontrolled bacterial, viral or fungal infections requiring systematic treatment;
- History of immunodeficiency, including positive HIV antibody test;
- Active chronic hepatitis B (HBV-DNA higher than the lower limit of detection), hepatitis C antibody positive;
- Patients who are unable to swallow oral drugs;
- History of serious cardiovascular and cerebrovascular diseases:
- Ventricular arrhythmias requiring clinical intervention;
- Acute coronary syndrome, congestive heart failure, stroke or other class III or above cardiovascular events within 6 months;
- New York Heart Association (NYHA) cardiac function grade ≥II or Left Ventricular Ejection Fraction (LVEF) <50%;
- Hypertension uncontrolled by standard treatment;
- Skin diseases that need systematic treatment;
- Patients who need long-term use of glucocorticoids (prednisone>10 mg/d or equivalent dose of the same drug) or other immunosuppressive agents during the study period or within 14 days before initiation of T601; Exceptions: local, ocular, intra-articular, intranasal, and inhaled glucocorticoid therapy; Short-term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);
- History of severe systemic reaction or side-effect after vaccinia vaccine injection;
- Known hypersensitivity to 5-FC or intolerance to 5-FC treatment;
- Known alcohol or drug dependence;
- Mental disorders or patients unable or unwilling to comply with the protocol requirements;
- Pregnant or lactating female patients;
- Patients who, as determined by the investigator, have other serious systemic diseases or laboratory abnormalities or other reasons, are not eligible to participate in this clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
START-SEH New Drug Phase I Clinical Trial Center
Shanghai
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- T601, T601+5-FC
- Keywords
- Advanced Malignant Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T601Biological
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+5-FCCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| T601/T601+5-FC | Experimental | 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. Receives: Biological: T601; Combination Product: T601+5-FC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs (adverse events)
According to NCI CTCAE 5.0., evaluate the AEs and the frequency and severity of adverse events.
Measured: Throughout the whole clinical trial, around 2 years.
Assessment of ORR (objective response rate)
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
Measured: For Part 2, ORR is measured on Day28 for cycle 1, and after cycle 1, ORR is measured when every 2 cycles finished (for Part 2, each cycle is 28 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of ORR (objective response rate)
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
Measured: For Part 3, ORR is measured at the end of each cycle (for Part 3, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of ORR (objective response rate)
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
Measured: For Part 4, ORR is measured at the end of each cycle (for Part 4, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of DCR (disease control rate)
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.
Measured: For Part 2, DCR is measured on Day28 for cycle 1, and after cycle 1, DCR is measured when every 2 cycles finished (for Part 2, each cycle is 28 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of DCR (disease control rate)
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.
Measured: For Part 3, DCR is measured at the end of each cycle (for Part 3, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of DCR (disease control rate)
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.
Measured: For Part 4, DCR is measured at the end of each cycle (for Part 4, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of PFS (progression free survival)
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.
Measured: For Part 2, PFS is measured on Day28 for cycle 1, and after cycle 1, PFS is measured when every 2 cycles finished (for Part 2, each cycle is 28 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of PFS (progression free survival)
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.
Measured: For Part 3, PFS is measured at the end of each cycle (for Part 3, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Assessment of PFS (progression free survival)
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.
Measured: For Part 4, PFS is measured at the end of each cycle (for Part 4, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
Secondary outcomes (8)
Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.
to evaluate pharmacokinetics characteristics of T601
Measured: For Part 1, blood samples are collected on Day1, Day4, Day14, Day21 of cycle 1; Day2, Day21 of cycle 2 (for Part 1, each cycle is 21 days).
Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.
to evaluate pharmacokinetics characteristics of T601
Measured: For Part 2, blood samples are collected on Day4, Day14, Day28 of cycle 1.
Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.
to evaluate pharmacokinetics characteristics of T601
Measured: For Part 3, blood samples are collected on Day8, Day15, Day32, Day46 of cycle 1.
Determination of 5-FC, 5-FU and FBAL concentration in plasma by updated LC/MS/MS method
Blood concentration monitoring of 5-FC, 5-FU, FBAL
Measured: For Part 2, blood samples are collected on Day7, Day14, Day18 of cycle 1.
Determination of 5-FC, 5-FU and FBAL concentration in plasma by updated LC/MS/MS method
Blood concentration monitoring of 5-FC, 5-FU, FBAL
Measured: For Part 3, blood samples are collected on Day19, Day20 of cycle 1.
T601 antibody test by ELISA
Immunological evaluations
Measured: For Part 1, Baseline, Day14, Day21 for cycle 1 and Day21 for following cycles (for Part 1, each cycle is 21 days).
T601 antibody test by ELISA
Immunological evaluations
Measured: For Part 2, Baseline, Day14, Day28 for cycle 1 and Day28 for following cycles (for Part 2, each cycle is 28 days).
T601 antibody test by ELISA
Immunological evaluations
Measured: For Part 3, Baseline, Day14, Day32, Day46 for cycle 1 and Day46 for following cycles (for Part 3, each cycle is 46 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start20 Nov 2019
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Tianjin Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226066
- Sponsor's protocol ID
- T60101
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2019
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04226066
- Acronym / sponsor ID
- T60101
- Conditions
- Advanced Malignant Solid Tumors
- Keywords
- Advanced Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Tasly Tianjin Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T601/T601+5-FC | Experimental | Biological: T601, Combination Product: T601+5-FCPart 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female, aged ≥18 years and ≤ 75;
- Part1-Part3: histological or cytological confirmed advanced malignant solid tumors patients who have received standard therapeutic options in previous treatment and now there's no standard therapy available; Part4: patients with gastric cancer, pancreatic cancer and hepatocellular carcinoma will be enrolled in Phase IIa Clinical Trial;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Expected survival of at least 3 months;
- Patient presenting with at least one evaluable lesion according to RECIST 1.1 in Part1-Part3; patient presenting with at least one measurable lesion according to RECIST 1.1 in Part4;
Key exclusion criteria (23 listed)
- Received chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to T601 treatment initiation, except for the following items:
- Received nitrosourea or mitomycin C within 6 weeks before T601 treatment initiation; Orally taken fluorouracil and small-molecule targeted drugs within 2 weeks before T601 treatment initiation or within 5 half-lives of the above drugs (subject to whichever is longer); Received the Chinese medicines with anti-tumor indications within 2 weeks before T601 treatment initiation;
- Prior participation in another clinical study involving an IMP with last intake within 4 weeks prior to T601 treatment initiation;
- Received major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks prior to T601 treatment initiation;
- The adverse reactions of previous anti-tumor therapy have not yet returned to CTCAE 5.0 ≤1 (except the toxicity that the investigator judged as no safety risk, such as hair loss);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T601Part1: 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. | Biological | T601/T601+5-FC |
| T601+5-FCPart2: 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. | Combination product | T601/T601+5-FC |
Primary outcome
AEs (adverse events)
Time frame: Throughout the whole clinical trial, around 2 years.
According to NCI CTCAE 5.0., evaluate the AEs and the frequency and severity of adverse events.
Assessment of ORR (objective response rate)
Time frame: For Part 2, ORR is measured on Day28 for cycle 1, and after cycle 1, ORR is measured when every 2 cycles finished (for Part 2, each cycle is 28 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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
Assessment of ORR (objective response rate)
Time frame: For Part 3, ORR is measured at the end of each cycle (for Part 3, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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
Assessment of ORR (objective response rate)
Time frame: For Part 4, ORR is measured at the end of each cycle (for Part 4, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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
Assessment of DCR (disease control rate)
Time frame: For Part 2, DCR is measured on Day28 for cycle 1, and after cycle 1, DCR is measured when every 2 cycles finished (for Part 2, each cycle is 28 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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.
Assessment of DCR (disease control rate)
Time frame: For Part 3, DCR is measured at the end of each cycle (for Part 3, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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.
Assessment of DCR (disease control rate)
Time frame: For Part 4, DCR is measured at the end of each cycle (for Part 4, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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.
Assessment of PFS (progression free survival)
Time frame: For Part 2, PFS is measured on Day28 for cycle 1, and after cycle 1, PFS is measured when every 2 cycles finished (for Part 2, each cycle is 28 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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.
Assessment of PFS (progression free survival)
Time frame: For Part 3, PFS is measured at the end of each cycle (for Part 3, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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.
Assessment of PFS (progression free survival)
Time frame: For Part 4, PFS is measured at the end of each cycle (for Part 4, each cycle is 46 days), until the date of disease progression or death, whichever came first, assessed up to 2 years.
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.
8 secondary outcomes
Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.
Time frame: For Part 1, blood samples are collected on Day1, Day4, Day14, Day21 of cycle 1; Day2, Day21 of cycle 2 (for Part 1, each cycle is 21 days).
Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.
Time frame: For Part 2, blood samples are collected on Day4, Day14, Day28 of cycle 1.
Quantification of viral genome in patients' blood samples by Quantitative Polymerase Chain Reaction.
Time frame: For Part 3, blood samples are collected on Day8, Day15, Day32, Day46 of cycle 1.
Determination of 5-FC, 5-FU and FBAL concentration in plasma by updated LC/MS/MS method
Time frame: For Part 2, blood samples are collected on Day7, Day14, Day18 of cycle 1.
Determination of 5-FC, 5-FU and FBAL concentration in plasma by updated LC/MS/MS method
Time frame: For Part 3, blood samples are collected on Day19, Day20 of cycle 1.
T601 antibody test by ELISA
Time frame: For Part 1, Baseline, Day14, Day21 for cycle 1 and Day21 for following cycles (for Part 1, each cycle is 21 days).
T601 antibody test by ELISA
Time frame: For Part 2, Baseline, Day14, Day28 for cycle 1 and Day28 for following cycles (for Part 2, each cycle is 28 days).
T601 antibody test by ELISA
Time frame: For Part 3, Baseline, Day14, Day32, Day46 for cycle 1 and Day46 for following cycles (for Part 3, each cycle is 46 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing T601 and T601+5-FC in people with Advanced Malignant Solid Tumors, run by Tasly Tianjin Biopharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin WANG, master (+86 22 8634 2163, tsl-wangxiaomin@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (adverse events) (time frame: Throughout the whole clinical trial, around 2 years.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.