Stomach CancerPhase 2/3NCT05427383
KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
A Phase 2/3 study testing KN026/Placbo Injection, Paclitaxel Injection and Docetaxel Injection in people with Stomach Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer
- What is being tested?
- KN026/Placbo Injection, Paclitaxel Injection and Docetaxel Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2022to Nov 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years;
- Histologically or cytology-confirmed HER2-positive locally advanced, recurrent, or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction); HER2 positive is defined as IHC 3+, or IHC 2+ with ISH test positive (HER2/CEP17 ratio ≥ 2.0, or mean HER2 copy number ≥ 6.0 signals/cell);
- Failure of at least first-line standard therapy (trastuzumab plus chemotherapy); Note: Neoadjuvant/adjuvant therapy previously administered with a trastuzumab-containing regimen can be considered first-line therapy if the subject has progressed disease during neoadjuvant/adjuvant therapy or within 6 months of completion of treatment;
- Stage 1 : At least one measurable lesion at baseline according to RECIST 1.1; Stage 2: At least one evaluable lesion at baseline according to RECIST 1.1; the area must not have received previous radiotherapy, or there must be evidence of significant progression after the end of radiotherapy;
- ECOG Performance Status of 0 to 1.
- Life expectancy ≥ 3 months.
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- 7. The function of major organs must meet the following criteria : Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil (ANC) ≥ 1.5×10^9/L; Platelet (PLT) ≥ 90×10^9/L; (No whole blood or component blood transfusion in the last 14 days; no pro-hematopoietic cytokines used in the last 7 days); AST, ALT ≤2.5× ULN (upper limit of normal value) (if liver metastases, AST, ALT ≤5×ULN); Total bilirubin (TBIL) ≤1.5×ULN; Albumin≥ 28 g/L; creatinine clearance ≥ 50 mL/min (standard Cockcroft-Gault formula applied); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR)/or prothrombin time (PT) ≤ 1.5×ULN; (It is allowed to receive anticoagulants at low stable doses, eg at a dose of aspirin 100 mg/day);
- Left ventricular ejection fraction (LVEF) ≥ 50% or lower limit of normal (LLN) in local sites, measured by echocardiography (ECHO), cardiac radionuclide scanning (MUGA) only in the absence of ECHO, with consistency at baseline and follow-up measurements;
- Subjects agreed to use effective contraception during the study and for 6 months after the last dose (women of childbearing age must confirm a negative serum pregnancy test within 7 days prior to enrollment);
- Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug. (Women of childbearing age must have a negative pregnancy test prior to study entry.)
- Subjects are able and willing to comply with the study protocol.
Who cannot join
- Subjects with untreated active brain metastases; Subjects will be admitted if their brain metastases have been treated and the metastases are stable (brain imaging at least 4 weeks prior to the first dose showed stable lesions with no new CNS symptoms, or CNS symptoms have returned to baseline and no hormonal therapy is required at least 14 days prior to the first dose of the investigational treatment), and there is no evidence of new or enlarged original brain metastases;
- Other investigational medications received within 4 weeks prior to the first study treatment, based on the time of the last trial dose;
- Antineoplastic therapy such as chemotherapy, small molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to the first study treatment; Have received Chinese herbal treatment with antitumor activity within 14 days before administration;
- Subjects recieved major surgery (e.g., transabdominal, transthoracic, etc.) within 28 days prior to the first study treatment; does not include minor procedures such as diagnostic puncture or infusion device implantation), or major surgery is expected to be required during the study;
- Previous cumulative doses of doxorubicin exceeding 320 mg/m^2, or equivalent conversion of other anthracyclines (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg pyrrubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone; except doxorubicin liposomes);
- Previous use of anti-HER2 therapy other than trastuzumab (eg, ADC, dual-antibody, small molecule targeted therapy, etc.).
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- Pregnant or lactating women; or intend pregnancy during the trial or within 6 months of the end of the trial;
- Subjects with a history of life-threatening allergies or known allergies to protein drugs or recombinant proteins or to one of excipients in KN026 drugs (histidine, glacial acetic acid, sucrose, and polysorbate 20) who have had a severe hypersensitivity reaction to trastuzumab.
- Adverse events have not returned to CTCAE 5.0 grade ≤ grade 1 or baseline from previous anti-tumor treatments , except for alopecia, skin pigmentation and those assessed by the investigators without potential safety risk.
- Uncontrollable diarrhoea (≥grade 2 that does not improve within 48 hours of medication);
- Subjects with the following history of cardiovascular disease:
- Subjects with uncontrolled hypertension (defined as sustained systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg despite antihypertensive medication);
- Any history of symptomatic congestive heart failure (NYHA classification II-IV); the absolute value of LVEF decreased by ≥10% and absolute value < 50% , or the absolute value of LVEF decreased by ≥15% , during or after treatment with trastuzumab or other anti-HER2 treatment;
- History of myocardial infarction within 6 months before treatment of the first dose;
- Subjects with angina and unstable angina within three months prior to treatment in the first dose;
- Severe arrhythmias and conduction abnormalities requiring antiarrhythmic therapy other than β-blockers or digoxin (except atrial fibrillation and paroxysmal supraventricular tachycardia) within 6 months prior to treatment in the first dose;
- QTcF > 450 ms (male); QTcF > 470ms (Female);
- Other heart diseases that the investigators consider clinically significant;
- Poorly controlled systemic diseases judged by investigators, including diabetes;
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy (eg, anti-infective drugs have been used for more than 1 week before the trial and will continue to be used), including tuberculosis infection;
- Received systemic corticosteroids (> 10 mg/day of prednisone, or equivalent amounts of other corticosteroids) within 2 weeks prior to treatment in the first dose; inhaled steroids or topical cortisol is permitted, corticosteroids are allowed for pre-treatment of certain chemotherapy drugs, and short-term (≤ 7 days) are allowed for the prevention or treatment of contrast allergy;
- History of noninfectious interstitial lung disease, or interstitial pneumonia requiring hormonal therapy;
- History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
- Active HBV [HBsAg or HBcAb-positive with HBV DNA > 500 IU/mL (or 2500 copies/mL)] or HCV infection [subjetcs with polymerase chain reaction (PCR)-negative HCV ribonucleic acid (RNA) can participate in this study] or HIV-positive or syphilis antibody positive (confirmed);
- History of any other malignant tumors within five years prior to the first dose, except cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle-invasive bladder cancer, localized low-risk prostate cancer [defined as stage ≤ T2a, Gleason score ≤ 6, and PSA ≤ 10 ng/mL at prostate cancer diagnosis (if measured) who have received radical therapy and no biochemical recurrence of prostate-specific antigen (PSA) can participate in this study], cervical/breast cancer in situ who have received radical treatment without any signs of recurrence and metastasis;
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) requiring drainage or diuretic therapy, within 2 weeks prior to the first dose of treatment; Diuretics for other reasons are permitted;
- Known mismatch repair deficient (dMMR) or highly unstable microsatellite (MSI-H) without previous PD-1/PD-L1 monoclonal antibody therapy;
- Unintentional weight loss of ≥5% within 1 month prior to the first dose, despite peripheral or central venous nutritional support;
- Inability to tolerate or refuse chemotherapy required by the protocol;
- The investigator considered the subject to be unsuitable for participation in this clinical study due to the presence of any clinical or laboratory abnormalities or history of systemic disease or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Jianming Xu, 010-66939843, jmxu2003@163.com
About this study
Official title: A Randomized, Multicenter, Phase Ⅱ/Ш Clinical Study to Evaluate the Efficacy of KN026 in Combination With Chemotherapy in Subjects With HER2 Positive Advanced Unresectable or Metastatic Gastric Cancer (Including Gastro-esophageal Junction Adenocarcinoma) Who Have Failed First-line Therapy.
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.
Read the detailed description
KN026-001 is a two-stage randomized, multicenter, phase Ⅱ/Ⅲ clinical study to evaluate the efficacy of KN026 in combination with chemotherapy in subjects with HER2-positive advanced unresectable or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction, who have failed first-line therapy.
Stage 1 is an open-label, multicenter, phase Ⅱ study to evaluate the safety and ORR in subjects receiving KN026 in combination with chemotherapy. Stage 2 is a randomized, double-blind, placebo-controlled phase Ш study to evaluate the OS and PFS in subjects receiving KN026 in combination with chemotherapy compared to placebo in combination with chemotherapy.
- Conditions
- Stomach Cancer
- Being tested
- KN026/Placbo Injection, Paclitaxel Injection, Docetaxel Injection, Irinotecan Injection
- Keywords
- Stomach Neoplasm, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026/Placbo InjectionDrug
IV KN026/Placebo at 30 mg/kg on D1, Q3W
Paclitaxel InjectionDrug
IV Paclitaxel at 175 mg/m² on D1, Q3W
Docetaxel InjectionDrug
IV Docetaxel at 75 mg/m² on D1, Q3W
Irinotecan InjectionDrug
IV Irinotecan at 125 mg/m² on D1, D8, Q3W
| Study group | Role | What they receive |
|---|---|---|
| KN026 + Paclitaxel/ Docetaxel/ Irinotecan | Experimental | IV KN026 at 30 mg/kg on D1 and IV Paclitaxel at 175 mg/m² on D1 or IV Docetaxel at 75 mg/m² on D1 or IV Irinotecan at 125 mg/m² on D1, D8, Q3W Receives: Drug: KN026/Placbo Injection; Drug: Paclitaxel Injection; Drug: Docetaxel Injection; Drug: Irinotecan Injection |
| Placebo + Paclitaxel/ Docetaxel/ Irinotecan | Experimental | IV Placebo at 30 mg/kg on D1 and IV Paclitaxel at 175 mg/m² on D1 or IV Docetaxel at 75 mg/m² on D1 or IV Irinotecan at 125 mg/m² on D1, D8, Q3W Receives: Drug: KN026/Placbo Injection; Drug: Paclitaxel Injection; Drug: Docetaxel Injection; Drug: Irinotecan Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) according to RECIST 1.1 by IRC
The time from the first dose of study treatment to the date of documented disease
Measured: Up to 2.5 years
Overall Survival (OS) according to RECIST 1.1 by IRC
The time from the first dose of study treatment until the date of death from any cause
Measured: Up to 2.5 years
Secondary outcomes (8)
ORR according to RECIST 1.1 by Investigator's Assessment and IRC
The percentage of patients with a complete response (CR) or partial response (PR)
Measured: Up to 2.5 years
DCR according to RECIST 1.1 by Investigator's Assessment and IRC
Number of subjects who achieved a best response of CR, PR, or SD during treatment
Measured: Up to 2.5 years
DOR according to RECIST 1.1 by Investigator's Assessment and IRC
The time from the first objective response (CR or PR) to documented PD, clinical progression, or death from any cause
Measured: Up to 2.5 years
Progression Free Survival (PFS) according to RECIST 1.1 by Investigator's Assessment
The time from the first dose of study treatment to the date of documented disease
Measured: Up to 2.5 years
Frequency and Severity of Adverse Events according to NCI CTCAE 5.0
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Measured: Up to 2.5 years
The concentration of KN026 drug in serum
The concentration of KN026 drug in serum
Measured: Up to 2.5 years
Incidence and titer of anti-drug antibody (ADA)
Incidence and titer of anti-drug antibody (ADA)
Measured: Up to 2.5 years
Incidence of neutralizing Antibody，Nab
Incidence of neutralizing Antibody，Nab
Measured: Up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start7 Apr 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427383
- Sponsor's protocol ID
- KN026-001
- Status last verified
- Dec 2023
- First submitted
- 14 Jun 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Phase Ⅱ/Ш Clinical Study to Evaluate the Efficacy of KN026 in Combination With Chemotherapy in Subjects With HER2 Positive Advanced Unresectable or Metastatic Gastric Cancer (Including Gastro-esophageal Junction Adenocarcinoma) Who Have Failed First-line Therapy.
- ClinicalTrials.gov ID
- NCT05427383
- Acronym / sponsor ID
- KN026-001
- Conditions
- Stomach Cancer
- Keywords
- Stomach Neoplasm, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jun 2022 (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.
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.
Detailed description
KN026-001 is a two-stage randomized, multicenter, phase Ⅱ/Ⅲ clinical study to evaluate the efficacy of KN026 in combination with chemotherapy in subjects with HER2-positive advanced unresectable or metastatic gastric cancer, including adenocarcinoma of the gastro-esophageal junction, who have failed first-line therapy.
Stage 1 is an open-label, multicenter, phase Ⅱ study to evaluate the safety and ORR in subjects receiving KN026 in combination with chemotherapy. Stage 2 is a randomized, double-blind, placebo-controlled phase Ш study to evaluate the OS and PFS in subjects receiving KN026 in combination with chemotherapy compared to placebo in combination with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KN026 + Paclitaxel/ Docetaxel/ Irinotecan | Experimental | Drug: KN026/Placbo Injection, Drug: Paclitaxel Injection, Drug: Docetaxel Injection, Drug: Irinotecan InjectionIV KN026 at 30 mg/kg on D1 and IV Paclitaxel at 175 mg/m² on D1 or IV Docetaxel at 75 mg/m² on D1 or IV Irinotecan at 125 mg/m² on D1, D8, Q3W |
| Placebo + Paclitaxel/ Docetaxel/ Irinotecan | Experimental | Drug: KN026/Placbo Injection, Drug: Paclitaxel Injection, Drug: Docetaxel Injection, Drug: Irinotecan InjectionIV Placebo at 30 mg/kg on D1 and IV Paclitaxel at 175 mg/m² on D1 or IV Docetaxel at 75 mg/m² on D1 or IV Irinotecan at 125 mg/m² on D1, D8, Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years;
- Histologically or cytology-confirmed HER2-positive locally advanced, recurrent, or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction); HER2 positive is defined as IHC 3+, or IHC 2+ with ISH test positive (HER2/CEP17 ratio ≥ 2.0, or mean HER2 copy number ≥ 6.0 signals/cell);
- Failure of at least first-line standard therapy (trastuzumab plus chemotherapy); Note: Neoadjuvant/adjuvant therapy previously administered with a trastuzumab-containing regimen can be considered first-line therapy if the subject has progressed disease during neoadjuvant/adjuvant therapy or within 6 months of completion of treatment;
- Stage 1 : At least one measurable lesion at baseline according to RECIST 1.1; Stage 2: At least one evaluable lesion at baseline according to RECIST 1.1; the area must not have received previous radiotherapy, or there must be evidence of significant progression after the end of radiotherapy;
- ECOG Performance Status of 0 to 1.
Key exclusion criteria (30 listed)
- Subjects with untreated active brain metastases; Subjects will be admitted if their brain metastases have been treated and the metastases are stable (brain imaging at least 4 weeks prior to the first dose showed stable lesions with no new CNS symptoms, or CNS symptoms have returned to baseline and no hormonal therapy is required at least 14 days prior to the first dose of the investigational treatment), and there is no evidence of new or enlarged original brain metastases;
- Other investigational medications received within 4 weeks prior to the first study treatment, based on the time of the last trial dose;
- Antineoplastic therapy such as chemotherapy, small molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to the first study treatment; Have received Chinese herbal treatment with antitumor activity within 14 days before administration;
- Subjects recieved major surgery (e.g., transabdominal, transthoracic, etc.) within 28 days prior to the first study treatment; does not include minor procedures such as diagnostic puncture or infusion device implantation), or major surgery is expected to be required during the study;
- Previous cumulative doses of doxorubicin exceeding 320 mg/m^2, or equivalent conversion of other anthracyclines (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg pyrrubicin = 2 mg daunorubicin = 0.5 mg normethoxydaunorubicin = 0.45 mg mitoxantrone; except doxorubicin liposomes);
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 |
|---|---|---|
| KN026/Placbo InjectionIV KN026/Placebo at 30 mg/kg on D1, Q3W | Drug | KN026 + Paclitaxel/ Docetaxel/ Irinotecan, Placebo + Paclitaxel/ Docetaxel/ Irinotecan |
| Paclitaxel InjectionIV Paclitaxel at 175 mg/m² on D1, Q3W | Drug | KN026 + Paclitaxel/ Docetaxel/ Irinotecan, Placebo + Paclitaxel/ Docetaxel/ Irinotecan |
| Docetaxel InjectionIV Docetaxel at 75 mg/m² on D1, Q3W | Drug | KN026 + Paclitaxel/ Docetaxel/ Irinotecan, Placebo + Paclitaxel/ Docetaxel/ Irinotecan |
| Irinotecan InjectionIV Irinotecan at 125 mg/m² on D1, D8, Q3W | Drug | KN026 + Paclitaxel/ Docetaxel/ Irinotecan, Placebo + Paclitaxel/ Docetaxel/ Irinotecan |
Primary outcome
Progression Free Survival (PFS) according to RECIST 1.1 by IRC
Time frame: Up to 2.5 years
The time from the first dose of study treatment to the date of documented disease
Overall Survival (OS) according to RECIST 1.1 by IRC
Time frame: Up to 2.5 years
The time from the first dose of study treatment until the date of death from any cause
8 secondary outcomes
ORR according to RECIST 1.1 by Investigator's Assessment and IRC
Time frame: Up to 2.5 years
DCR according to RECIST 1.1 by Investigator's Assessment and IRC
Time frame: Up to 2.5 years
DOR according to RECIST 1.1 by Investigator's Assessment and IRC
Time frame: Up to 2.5 years
Progression Free Survival (PFS) according to RECIST 1.1 by Investigator's Assessment
Time frame: Up to 2.5 years
Frequency and Severity of Adverse Events according to NCI CTCAE 5.0
Time frame: Up to 2.5 years
The concentration of KN026 drug in serum
Time frame: Up to 2.5 years
Incidence and titer of anti-drug antibody (ADA)
Time frame: Up to 2.5 years
Incidence of neutralizing Antibody，Nab
Time frame: Up to 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing KN026/Placbo Injection, Paclitaxel Injection and Docetaxel Injection in people with Stomach Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.
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 11 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) according to RECIST 1.1 by IRC (time frame: Up to 2.5 years). The study lists 2 primary outcomes in all. 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 19 Dec 2023.