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Colorectal CancerPhase 2DETECTNCT05578287

RC48 Plus Tislelizumab, Low-dose Capecitabine and Celecoxib for HER2-positive Metastatic Colorectal Cancer

A Phase 2 study testing Anti-HER2 ADC in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

As an established therapeutic target, HER2 is widely used in a variety of tumors, including breast cancer and gastric cancer, among which a variety of drugs, including trastuzumab, lapatinib and T-DM1, have been approved for the treatment of breast cancer and gastric cancer with HER2 amplification or overexpression. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Anti-HER2 ADC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
18 Jul 2023to 25 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A voluntarily signed and dated informed consent must be obtained from the subject in accordance with regulations and institutional guidelines before performing any protocol-related procedures other than routine care;
  • Aged 18-75;
  • Patients with pathologically or cytologically confirmed adenocarcinoma of the colon or rectum with evidence of locally advanced lesions or metastases that could not be resected;
  • ECOG performance status score is 0-1;
  • Detection of HER2-positive tumor tissue at any time before screening; HER2 positive was defined as the presence of HER2 3+ positive staining in more than 50% of tumor cells on IHC. Or patients with a HER2 score of 2+ should also be tested by FISH: HER2/CEP17 ratio ≥2.0.
  • Appropriate organ function based on the following laboratory test values obtained during the screening period:
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  • Neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, serum total bilirubin ≤ 1.5× upper normal limits, UNL), aspartate aminotransferase ≤ 2.5×UNL, alanine aminotransferase ≤ 2.5×UNL, serum creatinine ≤ 1.5×UNL;
  • Previous chemotherapy including oxaliplatin, irinotecan, and fluorouracil failed, including the following:
  • Subjects using oxaliplatin as adjuvant therapy should have treatment progression within 6 months of completion of adjuvant therapy; Patients who refused standard chemotherapy because of unacceptable toxicity to treatment will be admitted to the study;
  • Previous or no previous anti-HER2-targeted therapy, disease progression or intolerable toxicity during or within 3 months after treatment;
  • Measurable lesions, according to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1;

Who cannot join

  • Complicated with intestinal obstruction, active bleeding or perforation and requiring emergency surgery;
  • Major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic organ resection, etc. within the previous 4 weeks (the surgical incision should be completely healed before enrollment);
  • Had active coronary artery disease, severe/unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction in the 12 months prior to study enrollment;
  • Thrombotic or embolic events occurred within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis;
  • The New York Heart Association (NYHA) class II or higher congestive Heart failure;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the detection limit of the assay) or co-infection with hepatitis B and C;
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  • The presence of any active, known or suspected autoimmune disease. To allow enrollment of subjects in stable condition who do not require systemic immunosuppressive therapy, such as type I diabetes, hypothyroidism that requires only hormone replacement therapy, and skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, and alopecia);
  • The presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, pulmonary fibrosis, and acute pneumonia);
  • Common Terminology Criteria for Adverse events that have not resolved due to any previous treatment CTCAE) (version 5.0) grade 2 or higher toxicity (except peripheral neurotoxicity, anemia, alopecia, skin pigmentation);
  • Previous recipients of PD-1/PD-L1 inhibitors or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies;
  • A history of known or suspected allergies to any of the relevant drugs used in the study;
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Yanhong Deng, Ph.D contact

862013925106525

dengyanh@mail.sysu.edu.cn

Jianwei Zhang, Ph.D contact

00862013480216906

zhangjw25@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Yanghong Deng, PhD, 008613925106525, dengyanh@mail.sysu.edu.cn

    Jianwei Zhang, MD, 13480216906, zhangjw25@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Disitamab Vedotin Combined With Tislelizumab, Low-dose Capecitabine and Celecoxib as Salvage Therapy for HER2-positive Metastatic Colorectal Cancer: a Phase II Trial (DETECT)

As an established therapeutic target, HER2 is widely used in a variety of tumors, including breast cancer and gastric cancer, among which a variety of drugs, including trastuzumab, lapatinib and T-DM1, have been approved for the treatment of breast cancer and gastric cancer with HER2 amplification or overexpression. In colorectal cancer, HER2 as a target has also been focused in recent years.

Being tested
Anti-HER2 ADC
Keywords
Salvage therapy, HER-2 positive, HER-2 ADC, PD-1 inhibitor
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-HER2 ADCDrug

    Also called Disitamab Vedotin, Tislelizumab, Capecitabin, Celecoxib

    Disitamab Vedotin (2mg/kg, q2w), Tislelizumab (2mg/kg, q2w) combined with low-dose capecitabine 0.5g bid chemotherapy and the COX2 inhibitor celecoxib 200mg bid

Study groups in NCT05578287
Study groupRoleWhat they receive
Anti-HER2ExperimentalDisitamab Vedotin (2mg/kg, once every 2 weeks), Tislelizumab (2mg/kg, once every 2 weeks) combined with low-dose capecitabine 0.5g bid chemotherapy and the COX2 inhibitor celecoxib 200mg bid as salvage therapy
Receives: Drug: Anti-HER2 ADC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Safety was assessed by evaluation of AEs and serious AEs according to CTCAE 5.0

    Measured: 1 year

  2. Feasibility

    Feasibility was determined based on any treatment -related AEs leading to delays over 15 days or discontinous of treatment.

    Measured: 1 year

Secondary outcomes (4)

  1. Objective response rate

    The percentage of subjects with Complete Response (CR) and Partial Response (PR).

    Measured: 1 year

  2. disease control rate,DCR

    The percentage of subjects with total number of Complete Response (CR), Partial Response (PR) and stable disease (SD).

    Measured: 1 year

  3. Progression-free survival (PFS)

    The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first.

    Measured: 1 year

  4. Overall Survival (OS)

    OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start18 Jul 2023
  3. Primary completion15 Dec 2024 (estimated)
  4. Study completion25 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05578287
Sponsor's protocol ID
GIHSYSU-26
Acronym
DETECT
Status last verified
Dec 2023
First submitted
8 Oct 2022
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-HER2 ADC in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanhong Deng, Ph.D (862013925106525, dengyanh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05578287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.

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