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

NCT04555304 | Unknown Phase 2 DMC

• 1 other identifier: KH903-40101-CRP
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gastric Cancer; Gastroesophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival（PFS）

  Date of randomization until the date of first documented Progression or date of death from any cause， whichever came first

  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 (4)

• Objective Response Rate (ORR)

  Time from date of randomization until the date of first documented CR or PR，assessed up to18 months

• Duration of Response (DOR)

  Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months

• Disease Control Rate (DCR)

  Time from date of randomization until the date of first documented Progression，assessed up to18 months

• AE

  AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months

Study Arms (2)

KH903 + Paclitaxel

EXPERIMENTAL

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

Drug: KH903 + Paclitaxel

Placebo + Paclitaxel

ACTIVE COMPARATOR

IV Placebo IV paclitaxel 80 mg/m²

Drug: Placebo + Paclitaxel

Interventions

KH903 + Paclitaxel DRUG

KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle

KH903 + Paclitaxel

Placebo + Paclitaxel DRUG

Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle

Placebo + Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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.
• Age ≥ 18 years.
• Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma .
• Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
• 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.
• 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 .
• Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1.
• Life expectancy of ≥ 3 months.

You may not qualify if:

• Histologically confirmed squamous cell carcinoma or undifferentiated gastric cancer.
• 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.
• \. GI perforation and/or fistulae in the 6 months preceding randomization.
• Deep-vein thrombosis, pulmonary embolism (PE), or any other episode of Uncontrolled thromboembolism in the 6 months preceding randomization.
• Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack)
• Uncontrolled hypertension (≥150/100 mm Hg ) despite properly observed antihypertensive therapy.
• Known brain metastasis.
• Known allergy to paclitaxel or KH903.
• Serious concurrent infection or medical illness.
• Active hepatitis B virus or Active hepatitis C virus (HCV) infection at screening.
• Any condition which results in an undue risk for the patient during the trial participation according to the investigator.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

KH902 fusion protein; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• yi ba, PhD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yi ba, PhD

CONTACT

13752157916; bayi@timuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: September 18, 2020
• Study Start: September 15, 2020
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: September 18, 2020

Record last verified: 2020-09