First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer

NCT05648006 | Terminated Phase 2

• 1 other identifier: BH-OH2-010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, open, randomized controlled Phase II clinical study to evaluate the efficacy and safety of intratumoral injection of OH2 combined with capecitabine for first-line maintenance of advanced colorectal cancer.

Conditions

Advanced Colorectal Carcinoma

Keywords

Oncolytic Virus

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Time after treatment to clinical and radiographic disease progression will be evaluated.

  2 years

Secondary Outcomes (7)

• Durable response rate (DRR)

  2 years

• Overall survival (OS)

  2 years

• Objective response rate (ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Duration of response (DoR)

  2 years

Study Arms (2)

OH2+Capecitabine

EXPERIMENTAL

OH2: 10\^7 CCID50/mL intratumoral injection, once every 2 weeks; Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

Biological: OH2; Drug: Capecitabine

Capecitabine/Capecitabine+Bevacizumab

ACTIVE COMPARATOR

Capecitabine: 1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Drug: Capecitabine; Drug: Bevacizumab

Interventions

OH2 BIOLOGICAL

Oncolytic Type 2 Herpes Simplex Virus

OH2+Capecitabine

Capecitabine DRUG

1000 mg/m2, orally administered twice a day, D1 to D14, repeated every 3 weeks

Capecitabine/Capecitabine+Bevacizumab; OH2+Capecitabine

Bevacizumab DRUG

Bevacizumab: 7.5 mg/kg, intravenously, once every 3 weeks.

Capecitabine/Capecitabine+Bevacizumab

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old (including boundary values), male or female;
• Patients with advanced colorectal adenocarcinoma (Stage IV) with a definite histological or cytological diagnosis;
• Partial response (PR) or stable disease (SD) was evaluated in advanced colorectal cancer patients after 16 to 24 weeks of first-line treatment with fluorouracil-based chemotherapy combined with or without targeted drugs, and before the last chemotherapy to trial drug administration;
• The physical status score of the Eastern Oncology Consortium (ECOG) was 0\~1;
• Have at least one measurable or evaluable lesion according to RECIST 1.1;
• There are lesions suitable for intratumoral injection;
• At least 2 weeks and no more than 4 weeks after the end of the last first-line chemotherapy;
• Expected survival ≥12 weeks;
• Patients with asymptomatic BMS after treatment who are free of disease progression by computed tomography (CT) or magnetic resonance imaging (MRI), stable for at least 12 weeks and without steroid medication for at least 4 weeks;
• Laboratory examination (no blood transfusion or use of blood products, no correction therapy with granulocyte colony stimulating factor or other hematopoietic stimulating factor within 14 days prior to the first dose) :
• WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90 g/L;
• Serum creatinine ≤1.5×ULN;
• TBIL≤1.5×ULN;
• ALT and AST≤2.5×ULN; Patients with liver metastasis ≤5×ULN;
• Normal coagulation: International normalized ratio INR≤1.5×ULN or prothrombin time (PT, APTT) ≤1.5×ULN;

You may not qualify if:

• Patients who plan to undergo radical excision of metastatic lesions；
• Unrelieved intestinal obstruction or malabsorption syndrome;
• Adverse reactions caused by first-line chemotherapy drugs did not recover to ≤ grade 1 before randomization (except hair loss and peripheral neurotoxicity less than or equal to grade 2);
• Cardiovascular disease meets one of the following criteria: Congestive heart failure with ≥NYHA Level III heart function; Severe arrhythmias requiring medical treatment; Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or stenting within 6 months prior to initial administration; Left ventricular ejection fraction (LVEF) \<50%; Adjusted QTc interval (Fridericia formula correction) \>450 ms for men and \>470 ms for women, or risk factors for tip twisting ventricular tachycardia such as clinically significant hypokalemia as determined by the investigator, a family history of long QT syndrome, or a family history of arrhythmia (such as pre-excited syndrome); High blood pressure that is not effectively controlled;
• Patients had active infection or unexplained fever \>38.5℃ during screening or before initial administration;
• Patients with congenital or acquired immune deficiency (such as HIV infection), syphilis antibody positive and syphilis rapid plasma reactin-positive, active hepatitis (hepatitis B: HBsAg positive and HBV DNA≥2000 IU/mL; Hepatitis C: HCV antibody positive and HCV virus copy number \> upper limit of normal);
• Had received or was receiving or still required to receive other experimental agents or antiviral therapy within 4 weeks before randomization (hepatitis B patients were treated with entecavir, tenofovir fumarate dipifurofurl, adefovir dipivoxil sustainably);
• Participated in other clinical studies within 4 weeks prior to randomization;
• Known to be allergic to the test drug or its active ingredients or excipients, or severely allergic;
• A known history of psychotropic substance abuse, alcohol or drug abuse;
• Patients with active autoimmune disease or a history of autoimmune disease that may recur, but patients with the following diseases are not excluded and can be further screened:
• Type 1 diabetes
• Hypothyroidism (if controlled with hormone replacement therapy alone)
• Controlled celiac disease
• Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss)

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Interventions

Capecitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: October 17, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

CN (1)