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Trial Title:
RC48-ADC Combined With Bevacizumab in HER2-positive Advanced Colorectal Cancer
NCT ID:
NCT05785325
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Conditions: Keywords:
RC48-ADC
Her2-positive
Colorectal Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC48-ADC plus Bevacizumab
Description:
Administer RC48-ADC intravenously in combination with bevacizumab 5mg/kg once every two
weeks.
Arm group label:
RC48-ADC plus Bevacizumab
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.
Detailed description:
This is a single-arm, non-randomized, single-center trial. Enroll 30 patients with
HER2-expressed metastatic colorectal cancer and failure of standard therapy. Divide into
2 cohorts, including 10 patients with low HER2 expression (IHC 2+/FISH negative) and 20
patients with high HER2 expression (IHC 2+/FISH positive or IHC3+). 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withdrawn, or investigator judgment is made. The primary endpoints is objective response
rate (ORR), and secondary endpoints are progression-free survival (PFS), overall survival
(OS), and adverse effects (AE).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 or above, male or female;
2. Advanced inoperable colorectal cancer confirmed by pathology;
3. At least 1 measurable lesion meeting RECIST v1.1 criteria;
4. 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;
5. ECOG PS: 0-2 points;
6. Patients with HER2 expression: IHC results 2+ or 3+.
7. Predicted survival ≥12 weeks;
8. 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;
9. The subjects voluntarily joined the study and signed the informed consent. The
subjects had good compliance and cooperated with follow-up visits.
Exclusion Criteria:
1. Known allergy to MMAE conjugate of recombinant humanized anti-HER2 monoclonal
antibody for injection;
2. 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;
3. There are contraindications for the use of bevacizumab such as severe active
bleeding, severe arteriovenous thrombosis events, gastrointestinal obstruction and
perforation, and uncontrolled hypertension
4. Major surgical treatment, open biopsy, or significant traumatic injury was received
within 28 years prior to treatment
5. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The second affiliated hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuan Ying, ph.D & MD
Email:
yuanying1999@zju.edu.cn
Contact backup:
Last name:
YUAN YING
Email:
yuanying1999@zju.edu.cn
Start date:
August 20, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785325
