Clinical trial · Interventional
Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of Weekly Paclitaxel With or Without KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
NCT04555304CI-TRIAL-00047234unknownPhase 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 purpose of this study is to evaluate the efficacy and safety of the study drug known as KH903 in participants with gastric and gastroesophageal cance
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KH903 + Paclitaxel | Drug | — | UNRESOLVED |
| Placebo + Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KH903 + Paclitaxel
- description
- IV KH903 4 mg/kg IV paclitaxel 80 mg/m²
- interventionNames
- Drug: KH903 + Paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Placebo + Paclitaxel
- description
- IV Placebo IV paclitaxel 80 mg/m²
- interventionNames
- Drug: Placebo + Paclitaxel
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- Time from date of randomization until the date of first documented Progression or date of death from any cause, whichever came frist,assessed up to18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Prior to any detailed procedures of this study, subjects are able to understand, voluntarily participate in and sign the informed consent approved by the ethics committee. * 2.Age ≥ 18 years. * 3.Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma . * 4.Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. * 5.Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum or/and fluoropyrimidine doublet for unresectable or metastatic disease.Second line chemotherapy is suitable for paclitaxel. * 6.Laboratory test values must meet the following criteria. ANC ≥1.5×109/L, platelets ≥ 100×109/L, hemoglobin≥9g/dL. Blood creatinine ≤ 1.5 ×ULN or creatinine clearance ≥ 50 mL/min/m2. Total bilirubin ≤ 1.5× ULN(≤ 3 x ULN if Gilbert disease), AST and ALT ≤ 2.5× ULN (≤ 5×ULN if hepatic metastasis). INR ≤ 1.5× ULN, APTT ≤ 1.5× ULN. Dipstick proteinuria \<2+ or 24 hour proteinuria \<1g . * 7.Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1. * 8.Life expectancy of ≥ 3 months. Exclusion Criteria: * 1.Histologically confirmed squamous cell carcinoma or undifferentiated gastric cancer. * 2.Patients with disease progression within 6 months after previous adjuvant or neoadjuvant chemotherapy with paclitaxel, or patients with recurrent or metastatic gastric adenocarcinoma or GEJ adenocarcinoma treated with paclitaxel. * 3\. GI perforation and/or fistulae in the 6 months preceding randomization. * 4.Deep-vein thrombosis, pulmonary embolism (PE), or any other episode of Uncontrolled thromboembolism in the 6 months preceding randomization. * 5.Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) * 6.Uncontrolled hypertension (≥150/100 mm Hg ) despite properly observed antihypertensive therapy. * 7.Known brain metastasis. * 8.Known allergy to paclitaxel or KH903. * 9.Serious concurrent infection or medical illness. * 10.Active hepatitis B virus or Active hepatitis C virus (HCV) infection at screening. * 11.Any condition which results in an undue risk for the patient during the trial participation according to the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.