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Advanced Gastric CarcinomaPhase 2NCT06666166

SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer

A Phase 2 study testing SHR-A1811 & Apartinib in people with Advanced Gastric Carcinoma and Advanced Gastroesophageal Junction Adenocarcinoma, run by Yunpeng Liu at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHR-A1811 & Apartinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
Dec 2024to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
  • Age 18-75 years, including 18 and 75 year, male and female;
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
  • Has a life expectancy of greater than 3 months;
  • Cohort A: Has histologically confirmed diagnosis of unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
  • Cohort B: Has histologically confirmed diagnosis of unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
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  • There must be a measurable target lesion that meets the RECIST 1.1 criteria;
  • The function of major organs meets the following criteria(not transfused, not using haematopoietic factors and not corrected with drugs within 14 days):
  • Absolute neutrophil count (ANC) ≥1.5×10^9/L;
  • PLT ≥100×10^9/L;
  • Hb≥9g/dL;
  • ALB≥3.0g/dL;
  • total bilirubin ≤1.5 x ULN;
  • ALT/AST ≤ 2.5 x ULN (When there is liver metastasis, ALT/AST ≤ 5 x ULN);
  • Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL/min (according to Cockcroft-Gault formula);
  • prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Echocardiography （ECHO）/Cardiac radionuclide scan （MUGA showed i.LVEF≥50%);
  • Urine routine results showed that urine protein <1+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification <1g should be performed.
  • Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first dose and agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug. Male subjects whose partner is a female of childbearing potential must agree to use a highly effective method of contraception for the duration of the study up to 6 months after the last administration of study drug.

Who cannot join

  • Patients with meningeal metastases; Or patients with brain metastases that have not been treated with surgery or radiation, but those who have been stable for at least one month after treatment and have stopped using steroid drugs (such as 10mg/day prednisone or other equivalent hormones) for more than 2 weeks except;
  • Uncontrolled pleural effusion or ascites;
  • There are serious concomitant diseases: such as serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, hematopoietic disease, endocrine disease, cachexia, etc;
  • Previously received antibody drug conjugate therapy containing topoisomerase I inhibitors, such as trastuzumab deruxtecan (DS-8201), etc; Subjects underwent surgery (except diagnostic surgery), radiotherapy, chemotherapy, macromolecular targeted therapy or immunotherapy within 4 weeks before the first dose of the study drug；Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) whose last dose is less than 5 half-life period or 4 weeks (whichever is shorter) from the first dose; Subjects received palliative radiotherapy or local treatment less than 2 weeks after completion of treatment and before the first dose;
  • Subjects who have been treated with live vaccine or attenuated vaccine within 1 month prior to the first dose;
  • Subjects requiring systemic therapy with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to first dose, excluding nasal spray or inhaled corticosteroids.
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  • The toxicity caused by previous anti-tumor treatments has not recovered to ≤ CTCAE grade 1 (excluding hair loss; according to the researcher's judgment, some tolerable chronic grade II toxicity can be excluded);
  • Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); Active bleeding (such as local active ulcer lesions and fecal occult blood≥ ++), with a history of gastrointestinal bleeding within 6 months;
  • Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 × ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy;
  • Subjects were co-administered a potent CYP3A4 or CYP2D6 inhibitor or inducer within 3 weeks prior to first dosing;
  • Factors affecting oral administration of medications such as inability to swallow, chronic diarrhoea and intestinal obstruction;
  • Any active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, uveitis, enteritis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); and skin disorders (e.g., vitiligo, psoriasis, or alopecia) in which asthma has been in complete remission in childhood and has required no intervention in adulthood or in which systemic therapy is not required.subjects with autoimmune mediated hypothyroidism treated with thyroid replacement hormone at a stable dose and type I diabetes patients treated with insulin at a stable dose can be included;
  • Subjects with immunodeficiency disease, such as HIV infection, congenital or acquired immune dysfunction, organ transplantation；
  • Uncontrolled heart clinical symptoms or diseases, such as (1) New York Heart Association class II or higher heart failure; (2) unstable angina pectoris; (3) Myocardial ischaemia within 1 year; (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Complicated severe infection within 30 days prior to first dose, including but not limited to infection complications that require hospitalization, bacteremia, severe pneumonia, etc; active infections that have received therapeutic intravenous antibiotics within 2 weeks prior to the first dose. Subjects receiving prophylactic antibiotic treatment (such as preventing urinary tract infections) can be enrolled;
  • Subjects with active hepatitis B (HBsAg positive with HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive with HCV-RNA above the lower limit of detection of the analytical method);
  • Evidence of previously clinically significant lung diseases, including but not limited to interstitial pneumonitis, pneumonitis, pulmonary fibrosis and radiographic pneumonia (Excluding radioactive changes do not require treatment), or suspected subjects with this type of diseases founded during the screening period;
  • Allergy to any investigational drug or its excipients;
  • Concomitant other malignancies ≤5 years prior to enrollment, except adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localised prostate cancer, and ductal carcinoma;
  • Serious physical or mental illnesses or laboratory abnormalities. Any condition which, in the opinion of the Investigator, may be detrimental to the subject or result in the subject's inability to meet or perform the requirements of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiujuan Qu contact

13604031355

cmu1h_zlnk_trial@163.com

China1 site

  • The First Hospital of China Medical University

    Shenyang

    Xiujuan Qu, +8613604031355, cmu1h_zlnk_trial@163.com

Other trials in China

About this study

Official title: Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer

To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Read the detailed description

This is a prospective, dual arm, exploratory clinical research. To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Cohort A will enroll subjects with advanced gastric or gastroesophageal junction adenocarcinoma, while Cohort B will enroll subjects with advanced colorectal cancer.

The primary endpoint is objective remission rate (ORR). Secondary endpoints include disease control rate (DCR), duration of remission (DoR), progression-free survival (PFS), overall survival (OS) and safety.

Being tested
SHR-A1811 & Apartinib
Keywords
apatinib, advanced gastric or gastroesophageal junction adenocarcinoma, advanced colorectal cancer, SHR-A1811

What participants receive

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

  • SHR-A1811 & ApartinibDrug

    SHR-A1811 injection will be administered by intravenous infusion. And apatinib will be administered orally.

Study groups in NCT06666166
Study groupRoleWhat they receive
Gastric or gastroesophageal junction adenocarcinomaExperimentalNot described
Receives: Drug: SHR-A1811 & Apartinib
Advanced colorectal cancerExperimentalNot described
Receives: Drug: SHR-A1811 & Apartinib

What is being measured

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

  1. Objective response rate (ORR)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 month

Secondary outcomes (5)

  1. Duration of Response (DOR)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 12 months

  2. Disease control rate (DCR)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 month

  3. Progression-free survival (PFS)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 6 month

  4. Overall survival (OS)

    To evaluate the efficacy of anti-tumor

    Measured: baseline up to approximately 12 month

  5. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    To identify the incidence of AE and SAE in clinical trial

    Measured: From the initiation of the first dose to 28 days after the last dose

Timeline

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

  1. First posted30 Oct 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionDec 2028 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06666166
Sponsor's protocol ID
GC-IIT-SHR-A1811-Apa
Status last verified
Oct 2024
First submitted
29 Oct 2024
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-A1811 & Apartinib in people with Advanced Gastric Carcinoma and Advanced Gastroesophageal Junction Adenocarcinoma, run by Yunpeng Liu 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 19 inclusion and 20 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: opening soon, as of the sponsor's last update on 30 Oct 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 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiujuan Qu (13604031355, cmu1h_zlnk_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: baseline up to approximately 6 month). 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 NCT06666166.

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 30 Oct 2024.

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