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Advanced Colorectal CancerPhase 1NCT06200363

A Clinical Study of T3011 in Combination With Regorafenib in Patients With Advanced Colorectal Cancer

A Phase 1 study testing T3011 and Regorafenib in people with Advanced Colorectal Cancer, run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intravenous administration of T3011 at different doses in combination with oral regorafenib in the treatment of advanced colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
T3011 and Regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
21 Sep 2023to Nov 2024
Phase
Phase 1
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 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
  • At least one measurable lesion per RECIST1.1 criteria, and the lesion has not been treated with radiotherapy before (unless there is definite progression of the lesion after radiotherapy), the longest diameter of the lesion assessed by CT or MRI at baseline is ≥10 mm (the short axis of the lymph node is ≥15 mm); previously received at least second-line or higher standard treatment for advanced colorectal cancer;
  • ECOG performance status 0-2 (including threshold);
  • Weight ≥40kg
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  • 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;
  • Coagulation:
  • INR≤1.5 x ULN;
  • APTT≤1.5 x ULN;
  • Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening within 14 days of dosing. WCBP, as well as male patients with partners of WCBP, should consent to use at least one medically approved contraceptive method (e.g. surgical sterilization, oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the study treatment period and for at least 6 months after the last trial drug treatment;
  • Willingness to attend this study, to sign informed consent, to have good compliance, and to cooperate with follow-up visit.

Who cannot join

  • 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 imaging 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), gene therapy, cellular therapy or tumor vaccines;
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  • Requires continued concurrent oral or intravenous therapy with any drug against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs against HSV are allowed;
  • Patients plan to receive other anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy, anti-tumor Chinese herbal therapy, etc.) during the study;
  • 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;
  • Coronary angioplasty or stent implantation within 6 months prior to first administration of the experimental drug;
  • Rating of heart function as defined by the New York Heart Association (NYHA) standards>grade II; Cardiac valve abnormalities recorded by echocardiography (≥ grade 2). Note: Subjects with grade 1 cardiac valve abnormalities (such as mild regurgitation/stenosis) were admitted, but subjects with moderate valve thickening were excluded;
  • Left ventricular ejection fraction (LVEF) < the center lower limit. If no lower limit existed, LVEF˂50%;
  • Poor blood pressure control after antihypertensive treatment (i.e. systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
  • History of another malignant tumor, except the following:
  • Undergone potentially curative therapy and for ≥5 years prior to the first dose of study treatment and no malignancies with known active disease and low potential recurrence risk;
  • Adequately treated non-melanoma skin cancer or lentigo with no evidence of malignancy;
  • Adequately treated carcinoma in situ without evidence of disease;
  • Received live and attenuated vaccines within 4 weeks prior to initiation of study treatment, or plan to be vaccined during the study;
  • Previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease (including but not limited to ≥3 grade irAE) or intolerance to immunotherapy (including but not limited to anti-PD-(L)1 monoclonal Ab), except endocrine-related irAE that can be stably controlled by hormone replacement therapy;
  • Moderate to large amounts of pleural effusion, pericardial effusion, or ascites requiring drug or medical intervention (Patient may be eligible to participate following discussion with investigator and approval from the sponsor);
  • Unexplained >38.5℃ fever (except for tumor induced fever judged by PI) occurs during the screening period, baseline period or on the day of administration, which in the judgment of investigator, would interfere with patient participation in the study or patient's efficacy evaluation;
  • Any condition that PI considered may confuse the trial results, interfere with the patient's participation in the trial, or is not in the participant's best interest to participate in the trial, or a history of treatment or laboratory abnormalities, or other ineligibility for enrollment.
  • -

Trial locations and contacts

1 site in 1 country.

Meng Qiu, MD contact

028-85423203

qiumeng33@hotmail.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Meng Qiu, MD, 028-85423203, qiumeng33@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of Intravenous MVR-T3011 (T3011) in Combination With Oral Regorafenib in Patients With Advanced Colorectal Cancer

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intravenous administration of T3011 at different doses in combination with oral regorafenib in the treatment of advanced colorectal cancer.

Being tested
T3011, Regorafenib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T3011Drug

    T3011 will be administered intravenously on D1, 4, 8, 11, 15, 18 of each 28-day cycle.

  • RegorafenibDrug

    Regorafenib will be administered orally once daily for the first 21 days of each 28-day cycle according to NCCN and CSCO guidance.

Study groups in NCT06200363
Study groupRoleWhat they receive
T3011 + RegorafenibExperimentalNot described
Receives: Drug: T3011; Drug: Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event

    To evaluate the safety of intravenous T3011 in combination with oral regorafenib in the treatment of patients with advanced colorectal cancer.

    Measured: 28 days after EOT

Secondary outcomes (5)

  1. Overall response rate (ORR)

    To evaluate the efficacy of intravenous T3011 combined with oral regorafenib in the treatment of patients with advanced colorectal cancer (ORR will be assessed according to RECIST 1.1 \& iRECIST)

    Measured: Every 8 weeks until disease progression, consent withdraw, death or end of study, assessed up to 24 months.

  2. Disease control rate (DCR)

    To evaluate the DCR of intravenous T3011 combined with oral regorafenib in the treatment of patients with advanced colorectal cancer (DCR will be assessed according to RECIST 1.1 \& iRECIST)

    Measured: Every 8 weeks until disease progression, consent withdraw, death or end of study, assessed up to 24 months.

  3. Progression-free Survival (PFS)

    To evaluate the PFS of intravenous T3011 combined with oral regorafenib in the treatment of patients with advanced colorectal cancer (PFS will be assessed according to RECIST 1.1 \& iRECIST)

    Measured: Every 8 weeks until disease progression, consent withdraw, death or end of study, assessed up to 24 months.

  4. Overall survival (OS)

    To evaluate the OS of intravenous T3011 combined with oral regorafenib in the treatment of patients with advanced colorectal cancer

    Measured: 24 months

  5. Quality of life questionnaire (QLQ-C30)

    The EORTC Core Questionnaire (QLQ-C30) is widely used to measure quality of life in oncology. For self-reported general health and psychological distress, a higher score indicated worse health.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start21 Sep 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200363
Sponsor's protocol ID
MVR-T3011-ES-EC61-CRC
Status last verified
Dec 2023
First submitted
12 Oct 2023
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T3011 and Regorafenib in people with Advanced Colorectal Cancer, run by West China Hospital at 1 site 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 20 inclusion and 28 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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 Meng Qiu, MD (028-85423203, qiumeng33@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event (time frame: 28 days after EOT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200363.

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 11 Jan 2024.

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