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

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

RC48-ADC plus Bevacizumab

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Trial in China, only for patients with metastatic HER2-expressed colorectal cancer.
Combination of  RC48-ADC (a novel humanized anti-HER2 antibody-drug conjugate (ADC)) with bevacizumab (Avastin).
Measurable disease required. Patients need to have prior standard therapy (Folfox, Folfiri) that has failed them.

Location Location Status
China
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejinag 310009
Recruiting

Contacts

Inclusion Criteria

Inclusion Criteria:

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;
Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) with negative results within 7 days prior to inclusion and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last test drug administration. For males, consent is required to use an appropriate method of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug;
The subjects voluntarily joined the study and signed the informed consent. The subjects had good compliance and cooperated with follow-up visits.

Exclusion Criteria

Exclusion Criteria:

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.

NCT ID

NCT05785325

Date Trial Added

2023-03-27

Updated Date

2023-03-27