Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy

Kanghong Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer; Gastroesophageal Cancer

Treatments: Drug: Placebo + Paclitaxel; Drug: KH903 + Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04555304

KH903-40101-CRP

Details and patient eligibility

About

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

Enrollment: 81 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

81 participants in 2 patient groups

KH903 + Paclitaxel

Experimental group

Description:

IV KH903 4 mg/kg IV paclitaxel 80 mg/m²

Treatment:

Drug: KH903 + Paclitaxel

Placebo + Paclitaxel

Active Comparator group

Description:

IV Placebo IV paclitaxel 80 mg/m²

Treatment:

Drug: Placebo + Paclitaxel