Clinical trial NCT04555304: Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Gastroesophageal Cancer
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Time from date of randomization until the date of first documented CR or PR，assessed up to18 months
measure: Duration of Response (DOR)
timeFrame: Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months
measure: Disease Control Rate (DCR)
timeFrame: Time from date of randomization until the date of first documented Progression，assessed up to18 months
measure: AE
timeFrame: AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: yi ba, PhD
role: PRINCIPAL_INVESTIGATOR
References: