The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors

NCT05964543 | Unknown Phase 1 DMC

• 1 other identifier: Q-1802-201
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.

Conditions

Gastroesophageal Junction (GEJ) Adenocarcinoma

Keywords

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events(TRAE)

  TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802

  From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months

• Objective response rate (ORR)

  ORR is defined as proportion of participants with complete response, partial response (CR+PR).

  From the first dose of study drug administration up to 6 months after the last pts in,up to19 months

Secondary Outcomes (1)

• Progression-free survival (PFS)

  From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months

Study Arms (2)

Phase Ib: Dose escalation Q-1802+XELOX,

EXPERIMENTAL

According to "3+3" design, a dose of Q-1802 with two dose groups from low to high and one cycle fixed-dose XELOX will be given in DLT observation period. After DLT observation period, Q-1802+XELOX will be given by investigator,s decision until the subject meets study treatment discontinuation criteria.

Drug: Q-1802 Injection,Oxaliplatin Injection,Capecitabine

Phase II: Q-1802 + XELOX Vs XELOX ;

PLACEBO COMPARATOR

Phase II:Participants will be randomized to group A and B. Group A:receive a dose of Q-1802 at Cycle 1 Day 1 followed by a same dose in subsequent cycles every 2 weeks. Additionally, participants will receive XELOX (capecitabine/oxaliplatin) treatment until investigator confirmed disease progression or a total of 8 treatments (each cycle is defined as approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive Q-1802 a every 2 weeks each cycle and capecitabine every 3 weeks at the investigator's discretion until the subject meets study treatment discontinuation criteria. Group B:Participants will receive XELOX (capecitabine/oxaliplatin) treatment alone until a total of 8 treatments (each cycle is defined as approximately 21 days). subjects may continue to receive capecitabine every 3 weeks at the investigator's discretion.

Drug: Q-1802 Injection,Oxaliplatin Injection,Capecitabine

Interventions

Q-1802 Injection,Oxaliplatin Injection,Capecitabine DRUG

Q-1802：A dose Q-1802 will be administered intravenously Q2W. XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle.

Also known as: Q-1802,Oxaliplatin Injection,Xeloda

Phase II: Q-1802 + XELOX Vs XELOX ;; Phase Ib: Dose escalation Q-1802+XELOX,

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least one measurable lesion per RECIST (v1.1);
• Patients with medium or high expression of Claudin18.2 in tumor tissue samples tested by immunohistochemistry in central laboratory were included;
• Patients with untreated, unresectable advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with negative HER-2 immunohistochemistry or FISH test (HER-2 immunohistochemistry 0/1+ confirmed by a qualified local or central laboratory, or 2+ confirmed negative by FISH test) were included;
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening and no deterioration occurs within two weeks before enrollment;
• Life expectancy period ≥ 12 weeks;
• Patients who have sufficient baseline organ function.

You may not qualify if:

• Receive anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the treatment drug, whichever is shorter;
• Patients who have previously used Claudin 18.2 products for treatment;
• With uncontrolled diseases;
• Who are allergic to the study drug or any of its components;
• Patients with a history of other primary malignant tumors at the time of screening, except for cured skin Basal-cell carcinoma or Cutaneous squamous-cell carcinoma or cervical Carcinoma in situ.

Sponsors & Collaborators

• QureBio Ltd.: lead

Study Sites (1)

Beijing cancer hospical

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma; Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lin Shen, MD

  Department of Medical Oncology, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LI WEI, MD

CONTACT

86-021-50920280; weili@qurebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus XELOX,Arm B Standard treatment group: XELOX alone

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 28, 2023
• Study Start: June 21, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)