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

NCT06200363 | Unknown Phase 1

• 1 other identifier: MVR-T3011-ES-EC61-CRC
• Study Type: interventional
• Target: 15
• 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 intravenous administration of T3011 at different doses in combination with oral regorafenib in the treatment of advanced colorectal cancer.

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse event

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

  28 days after EOT

Secondary Outcomes (5)

• Overall response rate (ORR)

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

• Disease control rate (DCR)

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

• Progression-free Survival (PFS)

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

• Overall survival (OS)

  24 months

• Quality of life questionnaire (QLQ-C30)

  Up to 24 months

Study Arms (1)

T3011 + Regorafenib

EXPERIMENTAL

Drug: T3011; Drug: Regorafenib

Interventions

T3011 DRUG

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

T3011 + Regorafenib

Regorafenib DRUG

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

T3011 + Regorafenib

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
• 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
• 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:

• 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;
• 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;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Interventions

regorafenib

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 21, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Locations

CN (1)