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

Primary Purpose

Gastric Cancer, Gastroesophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

KH903 + Paclitaxel

Placebo + Paclitaxel

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KH903 + Paclitaxel

Placebo + Paclitaxel

Arm Description

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

IV Placebo IV paclitaxel 80 mg/m²

Outcomes

Primary Outcome Measures

Progression-free survival（PFS）

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

Secondary Outcome Measures

Objective Response Rate (ORR)

Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)

Duration of Response (DOR)

is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months

Disease Control Rate (DCR)

Percentage of Participants who have achieved CR, PR and SD to study treatment;

Number of Subjects with treatment-related adverse events (AEs)Defined by all

Full Information

NCT ID

NCT04555304

First Posted

August 5, 2020

Last Updated

September 14, 2020

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04555304

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2020 (Anticipated)

Primary Completion Date

January 15, 2022 (Anticipated)

Study Completion Date

January 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu Kanghong Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Gastroesophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KH903 + Paclitaxel

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo + Paclitaxel

Arm Type

Active Comparator

Arm Description

IV Placebo IV paclitaxel 80 mg/m²

Intervention Type

Drug

Intervention Name(s)

KH903 + Paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo + Paclitaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival（PFS）

Description

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

Time Frame

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 Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)

Time Frame

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

Title

Duration of Response (DOR)

Description

is defined as the time from first documented evidence of CR or PR until the date of first documented progression as assessed by RECIST 1.1 or death; assessed up to18 months

Time Frame

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

Title

Disease Control Rate (DCR)

Description

Percentage of Participants who have achieved CR, PR and SD to study treatment;

Time Frame

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

Title

Description

Number of Subjects with treatment-related adverse events (AEs)Defined by all

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

yi ba, PhD

Phone

13752157916

bayi@timuch.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yi ba, PhD

Organizational Affiliation

Tianjin Medical University Cancer Institute and Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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