CClinicalTrials.gg
Status unknownNCT05785325Updated Oct 31, 2023

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

A Phase 2 interventional study of RC48-ADC plus Bevacizumab in Colorectal Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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 Medication must be discontinued until disease progression, intolerable toxicity, informed consent is withdrawn, or investigator judgment is made.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).

02

Conditions studied

  • Colorectal Cancer

Keywords

  • RC48-ADC
  • Her2-positive
  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 30 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    RC48-ADC plus Bevacizumab

    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

  • DrugRC48-ADC plus Bevacizumab

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

06

What researchers measure

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)

    Time frame: From Baseline to disease progress, up to 18 months

Secondary outcomes

  1. Progression free survival

    Progression-free survival is defined as the time from enrollment to the first documented disease progression according to RECIST version 1.1, or to death from any cause, whichever occurred first

    Time frame: From Baseline to primary completion date, about 2 years

  2. Overal survival

    Time from randomization to death (from any cause)

    Time frame: From Baseline to primary completion date, about 5 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05785325
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
Aug 20, 2023
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Oct 31, 2023

Study contacts

Caixia Dong
Contact
dcx_1982@163.com
+86 15068882349
Ying Yuan
Contact
yuanying1999@zju.edu.cn
+86 13858193601
Ying Yuan
study chair · The Second Affiliated Hospital of Medical College of Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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