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

NCT06776770 | Recruiting Phase 1

• 1 other identifier: ADE-GC-Ib/II-XELOX
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer

Keywords

Adebrelimab plus capecitabine and oxaliplatin

Outcome Measures

Primary Outcomes (4)

• Dose-limiting toxicity（DLT）

  Dose-limiting toxicity

  48 months

• Maximum tolerated dose (MTD)

  Maximum tolerated dose

  48 months

• Recommended Dose for Phase II Clinical Study (RP2D)

  Recommended Dose for Phase II Clinical Study

  48 months

• Objective Response Rate (ORR)

  Objective Response Rate

  48 months

Secondary Outcomes (5)

• Median progression-free survival (PFS)

  48 months

• Time-To-Progression (TTP)

  48 months

• Disease control rate (DCR)

  48 months

• Duration of Response (DoR)

  48 months

• overall survival (OS)

  48 months

Study Arms (1)

Adebrelimab plus capecitabine and oxaliplatin

EXPERIMENTAL

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

Drug: Adebrelimab

Interventions

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.

Also known as: Adebrelimab Injection

Adebrelimab plus capecitabine and oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. The patients voluntarily participated in the study and signed the informed consent; 2. ≥ 18 years old (calculated on the day of signing informed consent), both male and female; 3. Patients with pathologically confirmed gastric cancer (GC) or gastroesophageal junction cancer (GEJC) who were histologically confirmed to be adenocarcinoma and had not received antineoplastic therapy for GC or GEJC; 4. No prior systemic therapy for advanced or metastatic disease. Prior adjuvant or neoadjuvant chemotherapy for GC and GEJC,Radiotherapy or chemoradiotherapy, provided that the last dose of the last drug (based on the last dose) occurred at least 6 months prior to enrollment. Palliative radiotherapy is allowed, but it must be completed 2 weeks before enrollment; 5. Human epidermal growth factor receptor 2 negative or unknown; 6. At least one measurable lesion according to the solid tumor efficacy evaluation criteria (RECIST v1.1); 7. The Eastern Cooperative Oncology Group (ECOG) physical status score was 0-1. 8. Expected survival \> 12 weeks; 9. Adequate organ and bone marrow function, as defined below: A) Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 10 \^ 9/L); B) Platelet count (PLT) ≥ 75,000/mm3 (75 × 10 \^ 9/L); C) hemoglobin (Hb) ≥ 8 G/dL (80 G/L); D) Serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 40 ml/min; E) Total bilirubin (BIL) ≤ 1.5 times the upper limit of normal (ULN); F) Aspartate transaminase or Alanine transaminase ≤ 2.5 times the upper limit of normal (ULN), and ≤ 5 × ULN for patients with liver metastasis; G) International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; H) Urine protein \< 2 +; if urine protein ≥ 2 +, 24-hour urine protein quantification shows that protein must be ≤ 1 G; I) Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.
• Female subjects of childbearing age must have a negative serum pregnancy test within 3 days prior to the start of study medication and be willing to use a medically approved highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) for the duration of the study and for 3 months after the last dose of study medication; Male subjects with a female partner of childbearing age were surgically sterilized or agreed to use an effective method of contraception for the duration of the study and for 3 months after the last study dose.

You may not qualify if:

• \. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.); 19. Long-term anticoagulation therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day); 20. Complicated with severe infection within 4 weeks before the first medication (e.g., need for intravenous antibiotics, antifungal or antiviral drug), or unexplained fever \> 38.5 ° C during screening/before first dose; 21. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 22. Participated in any other clinical study of the drug within 4 weeks prior to the first dose, or not more than 5 half-lives from the last study dose; 23. Known history of psychotropic substance abuse or drug use; 24. Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the results of the study, and who are not considered suitable for participation in the study by the investigator.

Sponsors & Collaborators

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: lead

Study Sites (1)

Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences

Shenzhen, Guangdong, 518100, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

yin wang

CONTACT

19925153518; Drwangsz@yeah.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: August 3, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2025

Record last verified: 2024-11

Locations

CN (1)