RC48-ADC Combined With Bevacizumab in HER2-positive Advanced Colorectal Cancer

NCT05785325 | Unknown Phase 2

• 1 other identifier: 2023-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II clinical study of RC48-ADC combined with Bevacizumab as late-line treatment in patients with HER2-expressed metastatic colorectal cancer. A total of 30 patients are planned to be enrolled.

Conditions

Colorectal Cancer

Keywords

RC48-ADC; Her2-positive; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective Response Rate was defined as the proportion of patients with a best objective response of complete response (CR) or partial response (PR) according to RECIST criteria (version 1.1)

  From Baseline to disease progress, up to 18 months

Secondary Outcomes (2)

• Progression free survival

  From Baseline to primary completion date, about 2 years

• Overal survival

  From Baseline to primary completion date, about 5 years

Study Arms (1)

RC48-ADC plus Bevacizumab

EXPERIMENTAL

Administer RC48-ADC intravenously in combination with bevacizumab 5mg/kg once every two weeks. Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made.

Drug: RC48-ADC plus Bevacizumab

Interventions

RC48-ADC plus Bevacizumab DRUG

Administer RC48-ADC intravenously in combination with bevacizumab 5mg/kg once every two weeks.

RC48-ADC plus Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Age 18 or above, male or female;
• Advanced inoperable colorectal cancer confirmed by pathology;
• At least 1 measurable lesion meeting RECIST v1.1 criteria;
• Patients who had received at least oxaliplatin, irinotecan, and fluorouracil for advanced or metastatic disease progressed or were intolerant were admitted to the study; Patients who had previously received anti-HER2 therapy such as trastuzumab and lapatinib were allowed to be included;
• ECOG PS: 0-2 points;
• Patients with HER2 expression: IHC results 2+ or 3+.
• Predicted survival ≥12 weeks;
• The subjects voluntarily joined the study and signed the informed consent. The subjects had good compliance and cooperated with follow-up visits.

You may not qualify if:

• Known allergy to MMAE conjugate of recombinant humanized anti-HER2 monoclonal antibody for injection;
• Clinical symptoms or diseases of the heart that are not well controlled, such as heart failure of grade 2 or above; b. Unstable angina pectoris; c. Myocardial infarction within 1 year; d. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• There are contraindications for the use of bevacizumab such as severe active bleeding, severe arteriovenous thrombosis events, gastrointestinal obstruction and perforation, and uncontrolled hypertension
• Major surgical treatment, open biopsy, or significant traumatic injury was received within 28 years prior to treatment
• In the investigator's judgment, subjects had other factors that might have led to the termination of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, and family or social factors that might have affected subjects' safety or the collection of data and samples.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejinag, 310009, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ying Yuan

  The Second Affiliated Hospital of Medical College of Zhejiang University

  STUDY CHAIR

Central Study Contacts

Caixia Dong

CONTACT

+86 15068882349; dcx_1982@163.com

Ying Yuan

CONTACT

+86 13858193601; yuanying1999@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 27, 2023
• Study Start: August 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2022-12

Locations

CN (1)