Clinical trial · Interventional
The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors
A Phase I/II Clinical Trial to Evaluate the Safety Tolerance and Initial Efficacy of Q-1802 Combined With Standard Treatment in Patients With Gastrointestinal Tumors
NCT05964543CI-TRIAL-00068337unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroesophageal Junction (GEJ) Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Q-1802 Injection,Oxaliplatin Injection,Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase Ib: Dose escalation Q-1802+XELOX,
- description
- 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.
- interventionNames
- Drug: Q-1802 Injection,Oxaliplatin Injection,Capecitabine
- type
- PLACEBO_COMPARATOR
- label
- Phase II: Q-1802 + XELOX Vs XELOX ;
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria： 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. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available
No reference posted for this study.