A Phase Ib/II Study of Adebrelimab in Combination with Capecitabine and Oxaliplatin in Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Hospital Chinese Academy of Medical Science, Shenzhen Center

About this trial

In this study, the combination of Adebrelimab (PD-L1 monoclonal antibody) on the basis of standard treatment (two-drug chemotherapy regimen of fluorouracil and platinum drugs) may enhance the immune response in order to enhance the killing effect on tumor cells and bring survival benefits to patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1. Previous treatment with PD-1/PD-L1 antibodies, cytotoxic T lymphocyte-associated antigen-4 antibodies, or other PD-1/PD-L1 inhibitors; 2. Past hypersensitivity to monoclonal antibodies and inactive ingredients of this product; 3. Previous use of immunosuppressive drugs within 14 days prior to the first dose of study drug, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroid hormones (i.e., up to 10 mg/day of prednisolone or pharmacophysiologically equivalent doses of other corticosteroids).; 4. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study; 5. Patients with clinical signs and symptoms of central nervous system metastasis or other evidence that central nervous system metastasis has not been controlled are not suitable for inclusion according to the judgment of the investigator, and those with meningeal metastasis history or symptoms and signs need to be excluded; 6. Toxicity of previous antineoplastic therapy did not recover to the level of CTCAE v5.0 ≤ 1 or the level specified in the inclusion/exclusion criteria; except for other toxicities such as alopecia, which the investigator considered did not pose a safety risk to the patient; 7. Advanced patients with symptoms, dissemination to the viscera, and risk of life-threatening complications in the short term (including patients with uncontrollable massive exudates [thoracic, pericardial, abdominal], pulmonary lymphangitis, and liver involvement of more than 30%); 8. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis,Hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be included; subjects with asthma requiring medical intervention of bronchodilators can not be included); 9. Any other malignancy diagnosed within 3 years prior to study entry, except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, and hepatitis C virus-RNA above the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; 11.Myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac dysfunction, and poorly controlled arrhythmias (including Corrected QT Interval interval > 450 ms in men and > 470 ms in women) within 6 months prior to study entry. QTcF interval was calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 12.Hypertension that is not well controlled by antihypertensive medication (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg); 13. Coagulation dysfunction (INR > 1.5 or APTT > 1.5 × ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 14. Known hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc; 15. Patients with obvious hemoptysis or daily hemoptysis volume of half a teaspoon (2.5 ml) or more within 2 months before entering the study; 16. There were clinically significant bleeding symptoms or definite bleeding tendency within 3 months before entering the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + and above, or vasculitis; 17. Arterial/venous thrombotic events occurred within 6 months before entering the study, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism.

Trial design

Design model

Single group

Treatments tested in this trial

  • Adebrelimab

    Drug

    Phase I: Cohort 1: Adebrelimab 10 mg/kg Q3W plus capecitabine and oxaliplatin (XELOX regimen); 21-day treatment cycle; Cohort 2: Adebrelimab 1200 mg or 20 mg/kg Q3W plus capecitabine and oxaliplatin (XELOX regimen); 21-day treatment cycle. Phase II: Adebrelimab (RP2D, Q3W) + (XELOX regimen), with a 3-week (21-day) treatment cycle. XELOX regimen:Oxaliplatin 130 mg/m2 iv.gtt d1,Capecitabine 1,000 mg/m2 p.o.b.i.d.d1\~14.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Adebrelimab plus capecitabine and oxaliplatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity(DLT)

Dose-limiting toxicity

Time frame
48 months
2

Maximum tolerated dose (MTD)

Maximum tolerated dose

Time frame
48 months
3

Recommended Dose for Phase II Clinical Study (RP2D)

Recommended Dose for Phase II Clinical Study

Time frame
48 months
4

Objective Response Rate (ORR)

Objective Response Rate

Time frame
48 months

Secondary outcomes

1

Median progression-free survival (PFS)

Median progression-free survival

Time frame
48 months
2

Time-To-Progression (TTP)

Time-To-Progression

Time frame
48 months
3

Disease control rate (DCR)

Disease control rate

Time frame
48 months
4

Duration of Response (DoR)

Duration of Response

Time frame
48 months

Other outcomes

Sponsors and contacts

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