AzTrials
AzTrials

HER2 Gene MutationPhase 2/3NCT05673512

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer

A Phase 2/3 study testing Injection of IAH0968 + CAPEOX in people with HER2 Gene Mutation, run by SUNHO（China）BioPharmaceutical CO., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX, is designed for safety and tolerability in subjects with HER2-positive advanced or metastatic solid tumors. Phase IIb/III is an operational seamless adaptive design consisting of two phases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER2 Gene Mutation
What is being tested?
Injection of IAH0968 + CAPEOX
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
279 participants
Where
1 siteChina
Study dates
12 May 2023to 1 Mar 2026
Phase
Phase 2/3
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

  • Stage IIa only: advanced or metastatic solid tumor confirmed by histopathology or cytology.
  • Only stage IIb and III: Patients with mCRC confirmed by histopathology or cytology, who are not suitable for radical surgical excision or local therapy, and who have not previously received systemic antitumor therapy for CRC (including systemic chemotherapy, molecular targeted drug therapy, biotherapy and investigational therapy, and have completed adjuvant chemotherapy for ≥6 months) can be admitted to the group.
  • Age range from 18 to 75 years old (including the critical value), gender is not limited.
  • Proof of HER2-positive (IHC) 3+, or IHC 2+ and FISH +, by immunohistochemical (IHC) staining and/or fluorescence in situ hybridization (FISH), and wild type KRAS, NRAS, and BRAF genes. HER2 positive status was interpreted according to the current Chinese guidelines for detecting HER2 in gastric cancer.
  • According to the researchers' judgment, CAPEOX scheme is suitable.
  • At least one measurable lesion according to RECIST 1.1 criteria (tumor lesion located in the area of prior radiotherapy or other local regional treatment site is generally not considered as a measurable lesion unless it shows definite progression or persists three months after radiotherapy).
Show all 11Show fewer
  • The physical status score of the Eastern Oncology Consortium (ECOG) was 0-1.
  • Expected survival ≥3 months.
  • Adequate organ function: 1) Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days) : absolute neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥90×109/L, hemoglobin (HGB) ≥90 g /L; Liver function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), except for Gilbert syndrome; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, liver metastasis or liver cancer patients need AST and ALT≤5.0 times ULN. 3. Renal function: serum creatinine (Cr) ≤1.5 ULN; If creatinine Creatinine clearance (Ccr) ≥50 ml/min (calculated by Cockcroft-Gault formula) was required at 1.5 ULN. Coagulation function: prothrombin International Normalized ratio (INR) ≤1.5 ULN, activated partial thrombin time (APTT) ≤1.5 ULN.
  • Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) with their partner during the trial period and for at least 6 months after the last medication; Women of reproductive age must have a negative blood or urine pregnancy test 7 days before first use of the study drug.
  • Subjects must give informed consent to the study prior to the study and voluntarily sign written informed consent.

Who cannot join

  • Stage IIa only: chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other antitumor therapies were received within 4 weeks prior to the first use of the study drug, except for the following: 1 nitrosourea or mitomycin C was used within 6 weeks prior to the first use of the study drug; 2 Oral administration of fluoripyritics and small molecule targeted drugs 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug, whichever is longer; 3 Chinese patent drugs with anti-tumor indications were used within 2 weeks prior to the first use of the investigational drug.
  • Have received other investigational drugs or treatments that are not on the market within 4 weeks prior to use of the investigational drug.
  • Stage IIa only: Adverse reactions to previous antitumor therapy have not yet returned to the NCI CTCAE 5.0 scale evaluation ≤ Level 1 or relevant provisions of inclusion criteria (except for toxicities without safety risks as determined by the investigators, such as alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.).
  • Known hypersensitivity to any antibody-class drug (NCI CTCAE 5.0 rating ≥3) or to investigational drug, CAPEOX protocol active ingredient or inactive excipients.
  • Confirmed mismatch repair defect (dMMR) or high microsatellite instability (MSI-H) solid tumors (unless subject is unable to receive immune checkpoint inhibitors due to a pre-existing medical condition, or unknown MSI/MMR status).
  • Had major organ surgery (excluding needle biopsy) or significant trauma, or required elective surgery, within 4 weeks prior to initial use of the study drug.
Show all 23Show fewer
  • Received systemic administration of corticosteroids (prednisone \> 10 mg/day or equivalent dose of the same drug) or other immunosuppressant therapy, except: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; Short-term use of glucocorticoids for prophylactic treatment (e.g. to prevent shadow allergy).
  • Use of immunomodulatory drugs within 14 days (Appendix 5).
  • Received any live vaccine within 4 weeks prior to the first administration of the study drug.
  • Have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • There are clinical symptoms of brain parenchymal metastasis or meningeal metastasis. Patients with BMS who had been treated were enrolled if magnetic resonance imaging (MRI) or computed tomography (CT) showed no signs of progression at least 8 weeks after the end of treatment and 4 weeks before the first use of the study drug.
  • There is an active infection that currently requires intravenous anti-infective therapy.
  • A history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.
  • Active hepatitis B (HBsAg positive and HBV-DNA≥1.0×103 copies /mL or ≥2000IU/mL, active hepatitis C (HCV-RNA\> 1.0×103 copies /mL or \> 100 IU/mL).
  • Severe and uncontrollable lung disease (severe infectious pneumonia, interstitial lung disease, etc.).
  • Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: 1. Have serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.; 2 QT interval (QTcF) mean corrected by Fridericia method \> 470 ms;3 Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months prior to initial administration;4 Present with heart failure or left ventricular ejection fraction (LVEF)\&lt of the New York Heart Association (NYHA) cardiac function grade ≥II; 50%;5. Clinically uncontrollable hypertension.
  • Have an active or past autoimmune disease with a risk of recurrence (e.g., systemic lupus erythematosus, class Rheumatoid arthritis, vasculitis), clinically stable autoimmune thyroid disease, type I diabetes, vitiligo, Children with cured atopic dermatitis and psoriasis that does not require systemic treatment (within the last 2 years) are excluded.
  • Non-melanoma skin cancer that has been clinically cured for more than 2 years and is currently suffering from other malignant tumors, limitations Exceptions include prostate cancer, carcinoma in situ (such as cervical carcinoma in situ), etc.
  • There was clinically uncontrollable third space effusion, which was not suitable for inclusion by the investigator.
  • Known alcohol or drug dependence.
  • Have mental disorders or poor compliance.
  • Pregnant or lactating women.
  • The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable to participate in this clinical study for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    QU Xiujuan, PhD, 024-83282256, qu_xiujuan@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: To Evaluate IAH0968 in Combination With CAPEOX in a Phase II/III Clinical Study of HER2-positive Metastatic Colorectal Cancer

The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX, is designed for safety and tolerability in subjects with HER2-positive advanced or metastatic solid tumors. Phase IIb/III is an operational seamless adaptive design consisting of two phases. Phase I (Phase IIb) was designed to initially evaluate the efficacy and safety of IAH0968+CAPEOX in HER2-positive subjects with metastatic colorectal cancer, using PFS.

Read the detailed description

The Phase IIa of this clinical study, a dose-escalation study of IAH0968 in combination with CAPEOX regimen, was designed to evaluate Safety and tolerability of IAH0968+CAPEOX regimen in subjects with HER2-positive advanced or metastatic solid tumors.

Phase IIb/III uses an operational seamless adaptive design and consists of two phases. Phase I (Phase IIb) aims to initially evaluate the efficacy and safety of IAH0968+CAPEOX in HER2-positive subjects with metastatic colorectal cancer by PFS. Phase II (Phase III) was designed to evaluate the efficacy and safety of IAH0968+CAPEOX versus placebo +CAPEOX in HER2-positive subjects with metastatic colorectal cancer using PFS.

Being tested
Injection of IAH0968 + CAPEOX, PLACEBO+CAPEOX

What participants receive

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

  • Injection of IAH0968 + CAPEOXCombination product

    PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient

  • PLACEBO+CAPEOXCombination product

    PLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient

Study groups in NCT05673512
Study groupRoleWhat they receive
IAH0968+ CAPEOXActive comparatorIAH0968+ CAPEOX in HER2 positive metastatic colorectal cancer patient
Receives: Combination Product: Injection of IAH0968 + CAPEOX
CAPEOXActive comparatorPLACEBO+CAPEOX in HER2 positive metastatic colorectal cancer patient
Receives: Combination Product: PLACEBO+CAPEOX

What is being measured

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

  1. Progression-Free-Survival（PFS）

    treatment index

    Measured: 12 months

Timeline

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

  1. First posted6 Jan 2023
  2. Study start12 May 2023
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2026 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
279 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673512
Sponsor's protocol ID
IAH0968-202
Status last verified
Feb 2024
First submitted
3 Jan 2023
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Injection of IAH0968 + CAPEOX in people with HER2 Gene Mutation, run by SUNHO（China）BioPharmaceutical CO., Ltd. 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 23 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 20 Feb 2024. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free-Survival（PFS） (time frame: 12 months). 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 NCT05673512.

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 20 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in