Solid Tumor, AdultPhase 2NCT05322720
HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
A Phase 2 study testing EOC202 and albumin-bound paclitaxel in people with Solid Tumor, Adult, run by Taizhou EOC Pharma Co., Ltd..
Trial summary
Primary objective: To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer (response evaluation criteria in solid tumors, RECIST 1.1); Secondary… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- EOC202 and albumin-bound paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to May 2025
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understanding and voluntarily signing the informed consent form;
- Female, age ≥ 18 years and <65 years;
- Histopathologically and molecular pathologically confirmed HR positive, HER2 negative breast cancer (based on the latest test result);
- Notes:
- Positive HR is defined as positive estrogen receptor (ER), negative or positive progesterone receptor (PR) (≥1% positive stained cells will be regarded as positive receptor); Negative HER2: negative immunohistochemical (IHC) result (0, 1+), or IHC result 2+ and negative result of in situ hybridization (ISH) amplification;
- Progression after endocrine therapy, being suitable for late-stage rescue chemotherapy, including the following conditions (meeting any one of them):
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- Primary endocrine resistance: recurrence less than two years after adjuvant endocrine therapy, or progression of disease less than 6 months after late-stage 1st-line endocrine therapy. For the patients with primary endocrine resistance, no use of other systematic therapy except endocrine therapy in relapsed/progressive period (the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed). There were no more than 2 lines of systemic therapy for advanced disease previously.
- Secondary (acquired) endocrine resistance: recurrence more than 2 years after adjuvant endocrine therapy and within one year after discontinuation of it, or progression of disease ≥6 months after late-stage 1st-line endocrine therapy. For the patients with secondary (acquired) endocrine resistance, at least 1 line but no more than 3 lines of endocrine therapy for advanced disease are recommended (the combined use of CDK4/6 inhibitor, Everolimus or HDAC inhibitor with endocrine therapy is allowed), and the number of lines will not be calculated for adjuvant endocrine therapy. There were no more than 3 lines of systemic therapy for advanced disease previously.
- No use of chemotherapy for recurrent/metastatic breast cancer;
- At least one extracranial measurable lesion (RECIST 1.1);
- Peripheral blood absolute monocyte count (AMC) <0.25×109/L (tested by local laboratory, it is allowed to be repeated once if the AMC is ranged from 0.25~0.35×109/L at screening);
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-1;
- Expected survival ≥3 months;
- Recovery of toxicity induced by previous therapy (except alopecia) to grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0 [NCI CTCAE v5.0]) or normal level;
- Good organ function within 1 week prior to the first dose of study drug:
- Hematology: no transfusion of platelet or any growth factor within 7 days prior to the screening visit, white blood cell count ≥3×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90 g/L; Hepatic function: serum total bilirubin ≤1.5× upper limit of normal (ULN), or total bilirubin ≤3×ULN in case of Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, or AST and ALT≤5×ULN in case of hepatic metastasis; Renal function: serum creatinine ≤1.5×ULN.
- The female subjects of childbearing potential must have negative pregnancy test within 1 week prior to the first dose of study drug, and they and their spouses agree to take effective contraceptive measures during the study and within 6 months after the last dose
Who cannot join
- Known uncontrollable or symptomatic central nervous system metastasis, including brain metastasis or meningeal metastasis, or symptoms suggestive of cancerous meningitis, leptomeningeal disease and/or progressive growth. Patients with a history of central nervous system metastasis or spinal cord compression are allowed to be enrolled if they have received definite local treatment (e.g., radiotherapy, surgical therapy), have discontinued anticonvulsant drugs and steroids for at least 4 weeks prior to the first dose of study drug and have stable clinical manifestations;
- Previous use of high-dose chemotherapy plus hemopoietic stem cell transplantation;
- Grade 4 operation performed within 4 weeks prior to the first dose of study drug, or grade 2 or 3 operation performed within 7 days prior to the first dose of study drug;
- Abnormal thyroid function that is poorly controlled after treatment;
- Chemotherapy, endocrine therapy or treatment with other investigational product within 4 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer); or radiotherapy within 2 weeks prior to the first dose of study drug (except the palliative radiotherapy for non-target lesion, enrollment will be allowed if the toxicity is resolved);
- Serious or uncontrolled heart disease (New York Heart Association [NYHA] grade III-IV) within 6 months prior to the first dose of study drug, including myocardial infarction, severe/unstable angina pectoris, ≥grade 2 persistent arrhythmia in accordance with NCI CTCAE v5.0, atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure; or presence of cerebrovascular accident, including transient ischemic attack, symptomatic pulmonary embolism, etc.;
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- Presence of other malignant tumors within 5 years prior to the first dose of study drug (except for basal cell or squamous cell carcinoma of skin, superficial bladder cancer and carcinoma in situ of cervix, which have been cured);
- Other concomitant disease seriously hazardous to patient's safety or affecting completion of the study as judged by investigators, except for tumor;
- Presence of one of the following conditions: active infection considered by investigators that may affect patient's participation in the study or the study results; positive hepatitis B surface antigen, and hepatitis B virus (HBV) DNA copy > ULN (patients with HBV DNA copy reduced to normal range after antiviral therapy are allowed to be enrolled); positive hepatitis C virus antibody and hepatitis C virus (HCV) RNA copy >ULN; positive human immunodeficiency virus (HIV); or any serious infection requiring systematic treatment within 4 weeks prior to the first dose of study drug;
- Clinically significant abnormality indicated on electrocardiography (ECG), including but not limited to serious arrhythmia, prolonged QT interval (QTcF>470 ms, QTcF=QT/RR0.33); or presence of various conditions that may increase the risk of prolonged QT interval, e.g., known history of prolonged QTc, congenital long QT syndrome, Brugada syndrome, torsade de pointes, uncontrollable electrolyte disorder (e.g., calcemia, hypokalaemia and hypomagnesaemia, etc.);
- Previous diagnosis of autoimmune disease or requiring long-term use of systemic corticosteroids (dose >10 mg/day prednisone or equivalent) or other immunosuppressants within 4 weeks prior to the first dose of study drug; however, patients are allowed to be enrolled in the following conditions: in the absence of active autoimmune disease, inhaled or topical steroids, or adrenaline replacement therapy at the dose ≤10 mg/day Prednisone equivalent is allowed to be used;
- Treatment with systematic immunostimulatory drugs (including but not limited to interferon-α (IFN-α) and interleukin 2 (IL-2)) within 6 weeks or 5 half-lives prior to the first dose of study drug (whichever comes later);
- Vaccination with live attenuated vaccine, protein vaccine, mRNA or DNA vaccine within 4 weeks prior to the first dose of study drug, or expected to receive the above vaccines during the study;
- Previous allergy to macromolecular protein preparation or protein, or Quincke's edema (also known as angioneurotic edema), or known allergy to any component of the study drug;
- History of clear mental disorder, or history of psychotropic drug abuse, drug addiction or alcohol abuse;
- Received organ transplant;
- Women who are pregnant or breastfeeding;
- Having participated in any other drug clinical trial within 4 weeks prior to the first dose of study drug or currently receiving treatment in other clinical trials (except those who are participating in the follow-up of overall survival in one study);
- Patients with other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II Clinical Study to Evaluate the Safety and Efficacy of Recombinant hLAG-3 Fusion Protein (EOC202) Injection Combined With Albumin-bound Paclitaxel in Treatment of the Patients With HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
Primary objective:
To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer (response evaluation criteria in solid tumors, RECIST 1.1);
Read more
Secondary objectives:
- To evaluate other efficacy variables, such as objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and overall survival (OS), for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of HR positive, HER2 negative advanced breast cancer;
- To evaluate the safety of EOC202 combined with albumin-bound paclitaxel;
- To evaluate the immunogenicity of EOC202 combined with albumin-bound paclitaxel;
- To evaluate the change level of pharmacodynamic (PD) markers (Interferon-γ, CXCL-10).
Exploratory objectives:
To explore the correlation of baseline soluble MHC-II ligands in blood (lymphocyte activation gene-3 (Lag-3) and fibrin related antigen (FGL-1)) with safety, efficacy, PD and anti-drug antibody (ADA) in subjects in EOC202 combined with albumin-bound paclitaxel group.
Read the detailed description
Overall design:
This is a randomized, open, parallel-controlled study to evaluate the efficacy and safety of EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer.
This study plans to enroll 50 patients with HR positive, HER2 negative advanced breast cancer who have progression after endocrine therapy and are suitable for taxane therapy, and these patients will be 1:1 randomized into the following two groups for treatment:
Experimental group: EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); Control group: albumin-bound paclitaxel (100 mg/m2). One cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first.
No less than 6 cycles of therapy with albumin-bound paclitaxel will be given on the premise it is tolerable by the subject. For the combined therapy, if it is judged by investigators and approved by the sponsor that albumin-bound paclitaxel needs to be discontinued permanently for toxicity, the subject can continue to receive EOC202; on the contrary, if it is judged by investigators and approved by the sponsor that EOC202 needs to be discontinued permanently for toxicity, the subject can continue to receive albumin-bound paclitaxel.
- Conditions
- Solid Tumor, Adult
- Being tested
- EOC202, albumin-bound paclitaxel
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOC202Biological
EOC202 will be SC injection
albumin-bound paclitaxelDrug
albumin-bound paclitaxel will be Iv injection
| Study group | Role | What they receive |
|---|---|---|
| EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); | Active comparator | One cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first. Receives: Biological: EOC202; Drug: albumin-bound paclitaxel |
| albumin-bound paclitaxel (100 mg/m2). | Active comparator | One cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first. Receives: Drug: albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
To evaluate the progression-free survival (PFS)
Measured: up to 30 months
Secondary outcomes (7)
ORR
objective response rate (ORR)
Measured: 30 months
DCR
disease control rate
Measured: 30 months
CBR
clinical benefit rate
Measured: 30 months
OS
overall survival
Measured: 30 months
the safety of EOC202 combined with albumin-bound paclitaxel
To evaluate the safety of EOC202 combined with albumin-bound paclitaxel
Measured: 30 months
The immunogenicity of EOC202 combined with albumin-bound paclitaxel;
- evaluate the immunogenicity of EOC202 combined with albumin-bound paclitaxel;
Measured: 30 months
the change level of PD markers (Interferon-γ, CXCL-10)
To evaluate the change level of pharmacodynamic (PD) markers (Interferon-γ, CXCL-10)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322720
- Sponsor's protocol ID
- EOC202A2102
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Safety and Efficacy of Recombinant hLAG-3 Fusion Protein (EOC202) Injection Combined With Albumin-bound Paclitaxel in Treatment of the Patients With HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
- ClinicalTrials.gov ID
- NCT05322720
- Acronym / sponsor ID
- EOC202A2102
- Conditions
- Solid Tumor, Adult
- Keywords
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 12 Apr 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.
Primary objective:
To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer (response evaluation criteria in solid tumors, RECIST 1.1);
Secondary objectives:
- To evaluate other efficacy variables, such as objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and overall survival (OS), for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of HR positive, HER2 negative advanced breast cancer;
- To evaluate the safety of EOC202 combined with albumin-bound paclitaxel;
- To evaluate the immunogenicity of EOC202 combined with albumin-bound paclitaxel;
- To evaluate the change level of pharmacodynamic (PD) markers (Interferon-γ, CXCL-10).
Exploratory objectives:
To explore the correlation of baseline soluble MHC-II ligands in blood (lymphocyte activation gene-3 (Lag-3) and fibrin related antigen (FGL-1)) with safety, efficacy, PD and anti-drug antibody (ADA) in subjects in EOC202 combined with albumin-bound paclitaxel group.
Detailed description
Overall design:
This is a randomized, open, parallel-controlled study to evaluate the efficacy and safety of EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer.
This study plans to enroll 50 patients with HR positive, HER2 negative advanced breast cancer who have progression after endocrine therapy and are suitable for taxane therapy, and these patients will be 1:1 randomized into the following two groups for treatment:
Experimental group: EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); Control group: albumin-bound paclitaxel (100 mg/m2). One cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first.
No less than 6 cycles of therapy with albumin-bound paclitaxel will be given on the premise it is tolerable by the subject. For the combined therapy, if it is judged by investigators and approved by the sponsor that albumin-bound paclitaxel needs to be discontinued permanently for toxicity, the subject can continue to receive EOC202; on the contrary, if it is judged by investigators and approved by the sponsor that EOC202 needs to be discontinued permanently for toxicity, the subject can continue to receive albumin-bound paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); | Active comparator | Biological: EOC202, Drug: albumin-bound paclitaxelOne cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first. |
| albumin-bound paclitaxel (100 mg/m2). | Active comparator | Drug: albumin-bound paclitaxelOne cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Understanding and voluntarily signing the informed consent form;
- Female, age ≥ 18 years and <65 years;
- Histopathologically and molecular pathologically confirmed HR positive, HER2 negative breast cancer (based on the latest test result);
- Positive HR is defined as positive estrogen receptor (ER), negative or positive progesterone receptor (PR) (≥1% positive stained cells will be regarded as positive receptor); Negative HER2: negative immunohistochemical (IHC) result (0, 1+), or IHC result 2+ and negative result of in situ hybridization (ISH) amplification;
- Progression after endocrine therapy, being suitable for late-stage rescue chemotherapy, including the following conditions (meeting any one of them):
Key exclusion criteria (19 listed)
- Known uncontrollable or symptomatic central nervous system metastasis, including brain metastasis or meningeal metastasis, or symptoms suggestive of cancerous meningitis, leptomeningeal disease and/or progressive growth. Patients with a history of central nervous system metastasis or spinal cord compression are allowed to be enrolled if they have received definite local treatment (e.g., radiotherapy, surgical therapy), have discontinued anticonvulsant drugs and steroids for at least 4 weeks prior to the first dose of study drug and have stable clinical manifestations;
- Previous use of high-dose chemotherapy plus hemopoietic stem cell transplantation;
- Grade 4 operation performed within 4 weeks prior to the first dose of study drug, or grade 2 or 3 operation performed within 7 days prior to the first dose of study drug;
- Abnormal thyroid function that is poorly controlled after treatment;
- Chemotherapy, endocrine therapy or treatment with other investigational product within 4 weeks or 5 half-lives prior to the first dose of study drug (whichever is longer); or radiotherapy within 2 weeks prior to the first dose of study drug (except the palliative radiotherapy for non-target lesion, enrollment will be allowed if the toxicity is resolved);
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 |
|---|---|---|
| EOC202EOC202 will be SC injection | Biological | EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); |
| albumin-bound paclitaxelalbumin-bound paclitaxel will be Iv injection | Drug | EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2);, albumin-bound paclitaxel (100 mg/m2). |
Primary outcome
PFS
Time frame: up to 30 months
To evaluate the progression-free survival (PFS)
7 secondary outcomes
ORR
Time frame: 30 months
DCR
Time frame: 30 months
CBR
Time frame: 30 months
OS
Time frame: 30 months
the safety of EOC202 combined with albumin-bound paclitaxel
Time frame: 30 months
The immunogenicity of EOC202 combined with albumin-bound paclitaxel;
Time frame: 30 months
the change level of PD markers (Interferon-γ, CXCL-10)
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Xichun Hu, Ph.D principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EOC202 and albumin-bound paclitaxel in people with Solid Tumor, Adult, run by Taizhou EOC Pharma 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 17 inclusion and 19 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 12 Apr 2022. 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 Ying Tian, VP (+86-021-3175 7830, Ying.tian@eocpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 30 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 12 Apr 2022.