Gastric CancerPhase 2NCT04555304
Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Therapy
A Phase 2 study testing KH903 + Paclitaxel in people with Gastric Cancer and Gastroesophageal Cancer, run by Chengdu Kanghong Biotech Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Cancer
- What is being tested?
- KH903 + Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 15 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- KH903 + Paclitaxel, Placebo + Paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH903 + PaclitaxelDrug
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
Placebo + PaclitaxelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| KH903 + Paclitaxel | Experimental | IV KH903 4 mg/kg IV paclitaxel 80 mg/m² Receives: Drug: KH903 + Paclitaxel |
| Placebo + Paclitaxel | Active comparator | IV Placebo IV paclitaxel 80 mg/m² Receives: Drug: Placebo + Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival（PFS）
Date of randomization until the date of first documented Progression or date of death from any cause， whichever came first
Measured: 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)
Percentage of Participants with a Best Overall Response (BOR) of Partial Response (PR) or Complete Response (CR)
Measured: Time from date of randomization until the date of first documented CR or PR，assessed up to18 months
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
Measured: Time from first documented evidence of CR or PR until the date of first documented progression ，assessed up to18 months
Disease Control Rate (DCR)
Percentage of Participants who have achieved CR, PR and SD to study treatment;
Measured: Time from date of randomization until the date of first documented Progression，assessed up to18 months
AE
Number of Subjects with treatment-related adverse events (AEs)Defined by all
Measured: AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yi ba, PhD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555304
- Sponsor's protocol ID
- KH903-40101-CRP
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04555304
- Acronym / sponsor ID
- KH903-40101-CRP
- Conditions
- Gastric Cancer, Gastroesophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KH903 + Paclitaxel | Experimental | Drug: KH903 + PaclitaxelIV KH903 4 mg/kg IV paclitaxel 80 mg/m² |
| Placebo + Paclitaxel | Active comparator | Drug: Placebo + PaclitaxelIV Placebo IV paclitaxel 80 mg/m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KH903 + PaclitaxelKH903 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 | Drug | KH903 + Paclitaxel |
| Placebo + PaclitaxelPlacebo 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 | Drug | Placebo + Paclitaxel |
Primary outcome
Progression-free survival（PFS）
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
Date of randomization until the date of first documented Progression or date of death from any cause， whichever came first
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Time from date of randomization until the date of first documented CR or PR，assessed up to18 months
Duration of Response (DOR)
Time frame: 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 frame: Time from date of randomization until the date of first documented Progression，assessed up to18 months
AE
Time frame: AEs（NCI CTCAE 5.0） collected at each cycle，Assessed up to18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yi ba, PhD principal investigator
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KH903 + Paclitaxel in people with Gastric Cancer and Gastroesophageal Cancer, run by Chengdu Kanghong Biotech Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yi ba, PhD (13752157916, bayi@timuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（PFS） (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.