Solid Tumor, AdultPhase 1NCT03600090
Phase I Study of EOC202 Plus Paclitaxel in Chinese Patients With Metastatic Breast Cancer
A Phase 1 study testing EOC202 and Paclitaxel in people with Solid Tumor, Adult, run by Taizhou EOC Pharma Co., Ltd. at 1 site in China.
Trial summary
Open label, single arm, dose-escalation phase I study in ambulatory patients receiving first line chemotherapy for metastatic breast cancer. The treatment comprises of the standard 6 cycles of weekly paclitaxel (80 mg/m² IV at D1, D8 and D15 of a 28 day cycle) and two EOC202 doses (6 and 30 mg SC at D2 and D16 of a 28… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- EOC202 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2018to 25 Dec 2021
- Phase
- Phase 1
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must be able to understand and willing to sign the informed consent form, and to complete the trial procedure and follow-up examinations;
- Female patients with histologically or cytologically confirmed metastatic breast cancer;
- Patients with HER-2 negative, including hormone receptor (HR) positive/HER-2 negative and triple negative breast cancer (TNBC);
- Age 18-70 years (including the critical value);
- Patients who are judged by investigators as suitable to receive paclitaxel first-line chemotherapy;
- All female patients with childbearing potential must have a negative highly sensitive pregnancy test within 7 days prior to the first dose of investigational product, and as judged by investigators, will not breastfeed and be willing to use effective contraceptive measures during the trial and at least 6 months after the last dose;
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- ECOG performance status 0 or 1;
- Expected survival longer than 6 months;
- The previous adjuvant chemotherapy, targeted therapy, antitumor traditional Chinese medicine or Chinese drug preparation, radiotherapy or surgery prior to the first dose must have been completed for at least 4 weeks, endocrine therapy must have been completed for at least 2 weeks; and all the relevant toxicities (except for alopecia and other adverse events that are judged by investigators as tolerable) have been recovered to grade 1 or normal level.
- At least one measurable lesion as defined by RECISTV 1.1 evaluation criteria for solid tumors;
- Good organ function level; 1) Hematology: total white blood cell count ≥ 3x109/L; absolute neutrophil count (ANC) ≥ LLN(lower limit of normal), platelet count ≥ LLN, hemoglobin ≥ 9g/dL; 2) Liver: serum total bilirubin ≤ 1.5 upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 3xULN(for patients with Gilbert syndrome, total bilirubin≤ 3xULN is allowed; for patients with hepatic metastasis , total bilirubin ≤ 3xULN, AST and ALT≤ 5xULN are allowed); 3) Renal: serum creatinine ≤ 1.5 x ULN.
Who cannot join
- Previous chemotherapy for metastatic breast cancer;
- Patients with recurrence of breast cancer within 6 months after the last dose of previous adjuvant chemotherapy;
- Inability to discontinue CYP isoenzyme inhibitor or inducer prohibited in the protocol 2 weeks before the first dose and during the trial;
- Patients with symptomatic central nervous system metastases;
- Abnormality on HBV serum tests (5 items) and HBV-DNA (+), anti-HCV antibody (+), HCV-RNA (+), anti-HIV antibody (+), or other serious infection requiring systemic therapy within 4 weeks prior to the first dose of investigational product;
- Clinically significant ECG abnormality, including but not limited to serious arrhythmia, prolonged QTc (QTcF≥470ms, QTcF=QT/RR0.33), or existence of various factors that may increase the risk of prolonged QTc (hypokalemia, congenital long QT syndrome, or current use of any drug that is known to prolong QTc));
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- Serious or uncontrolled (NYHA III-IV) heart disease within 6 months prior to the first dose of investigational product, including myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure; or presence of cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism;
- History of autoimmune disease, immunodeficiency disease or organ transplantation (including allogeneic bone marrow transplantation), or previous hematopoietic stem cell rescue following chemotherapy, or having active autoimmune disease, immunodeficiency disease, or the disease requiring systemic steroid hormone (>10mg daily prednisone or equivalent dose to 10mg prednisone) or immunomodulatory drug for continuous treatment;
- Other malignant tumors other than breast cancer in the past three years (except successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix);
- 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 investigational product, including cremophor EL;
- History of clear mental disorder, or history of psychotropic drug abuse, drug addiction or alcohol abuse;
- Vaccination with live attenuated vaccine within 4 weeks prior to the first dose of investigational product, or expected vaccination with live attenuated vaccine during the trial or within 3 months after the end of combined therapy;
- Previous use of systemic immunomodulator prior to the first dose of investigational product, and discontinuation of the systemic immunomodulator ≤ 5 half-lives of the drug at the first dose;
- Receiving therapy in any other clinical trial within 4 weeks prior to the first dose of investigational product;
- Patients who are judged by investigators as unsuitable to participate in the clinical trial as participation in the trial may increase the risk or there may be other severe, acute or chronic disease that may interfere with the interpretation of the trial results;
- Patients who are not suitable to participate in the trial for other reasons, as judged by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of hLAG-3 Fusion Protein, EOC202 (Eftilagimod Alpha) Combined With Paclitaxel in Chinese Patients With Metastatic Breast Cancer
Open label, single arm, dose-escalation phase I study in ambulatory patients receiving first line chemotherapy for metastatic breast cancer. The treatment comprises of the standard 6 cycles of weekly paclitaxel (80 mg/m² IV at D1, D8 and D15 of a 28 day cycle) and two EOC202 doses (6 and 30 mg SC at D2 and D16 of a 28 day cycle) for 6 cycles. After completion of the combined therapy, the patients can continue to receive up to 6 cycles of EOC202 maintenance monotherapy (once every cycle on day 1 of each cycle).
Read the detailed description
This study is an open label, single arm, dose-escalation phase I study, performed in ambulatory setting with patients receiving first line chemotherapy for metastatic breast carcinoma. The standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle) will be given to subjects. Twenty mg i.v. dexamethasone will be given in the first cycle before each paclitaxel infusion. Corticosteroids will not be administered after the first chemotherapy cycle if the first 3 i.v. infusions of paclitaxel have been well tolerated.
Two EOC202 dose levels, 6 mg and 30 mg will be given to subjects during the cycle and be evaluated in successive cohorts of patients. For each dose level, 3 patients will be administered one subcutaneous dose every 2 weeks for a total of 24 weeks (12 injections in total), separated by 13-day administration-free intervals.
The 30 mg dose will be dosed to 3 new patients if the 6 mg dose has been deemed safe and well tolerated.
Cohort A - 3 patients at the 6 mg dose - will receive EOC202 administration in seriatim separated by four-week intervals for DLT observation. If safety/tolerability are acceptable at the end of the DLT observation periods, the study will proceed to the next dose.
Cohort B - 3 patients at the 30 mg dose - will receive EOC202 administration in seriatim separated by four-week intervals for DLT observation. If safety/tolerability are acceptable at the end of the 4-week observation periods, the study will proceed to the next phase.
Cohort C will comprise of additional 6 patients as the PK dose expansion group based on the recommended dose for expansion (RDE). The study procedure is the same with the corresponding dose group.
All patients will participate in a pharmacokinetic (PK) and pharmacodynamic (PD) study which involves additional blood samples.
- Conditions
- Solid Tumor, Adult
- Being tested
- EOC202, 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.
PaclitaxelDrug
Paclitaxol will be IV injection
| Study group | Role | What they receive |
|---|---|---|
| Arm EOC202 + Paclitaxol | Experimental | Biological: EOC202 This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle).
Two EOC202 dose levels (6 mg and 30 mg) will be evaluated in two cohorts of 18 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 48 weeks (12 s.c. injections in total), separated by 13-day intervals free of EOC202 administration.
The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy. Receives: Biological: EOC202; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
DLT and its incidence at each dose level
Measured: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 12 months
Secondary outcomes (5)
PFS
Progression-free Survival
Measured: up to 24 months
Cmax
Maximum Plasma Concentration
Measured: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
Tmax
Time at which maximum plasma concentration was observed
Measured: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
AUC 0-inf
Area under the plasma concentration-time curve from time zero to infinity
Measured: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
T1/2
Elimination Half-life
Measured: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Oct 2018
- Primary completion25 Dec 2021
- Study completion25 Dec 2021
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xichun Hu, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600090
- Sponsor's protocol ID
- EOC202A1101
- Status last verified
- Feb 2022
- First submitted
- 16 Jul 2018
- Last updated
- 31 Mar 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of hLAG-3 Fusion Protein, EOC202 (Eftilagimod Alpha) Combined With Paclitaxel in Chinese Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03600090
- Acronym / sponsor ID
- EOC202A1101
- Conditions
- Solid Tumor, Adult
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Taizhou EOC Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 25 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 26 Jul 2018 (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.
Open label, single arm, dose-escalation phase I study in ambulatory patients receiving first line chemotherapy for metastatic breast cancer. The treatment comprises of the standard 6 cycles of weekly paclitaxel (80 mg/m² IV at D1, D8 and D15 of a 28 day cycle) and two EOC202 doses (6 and 30 mg SC at D2 and D16 of a 28 day cycle) for 6 cycles. After completion of the combined therapy, the patients can continue to receive up to 6 cycles of EOC202 maintenance monotherapy (once every cycle on day 1 of each cycle).
Detailed description
This study is an open label, single arm, dose-escalation phase I study, performed in ambulatory setting with patients receiving first line chemotherapy for metastatic breast carcinoma. The standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle) will be given to subjects. Twenty mg i.v. dexamethasone will be given in the first cycle before each paclitaxel infusion. Corticosteroids will not be administered after the first chemotherapy cycle if the first 3 i.v. infusions of paclitaxel have been well tolerated.
Two EOC202 dose levels, 6 mg and 30 mg will be given to subjects during the cycle and be evaluated in successive cohorts of patients. For each dose level, 3 patients will be administered one subcutaneous dose every 2 weeks for a total of 24 weeks (12 injections in total), separated by 13-day administration-free intervals.
The 30 mg dose will be dosed to 3 new patients if the 6 mg dose has been deemed safe and well tolerated.
Cohort A - 3 patients at the 6 mg dose - will receive EOC202 administration in seriatim separated by four-week intervals for DLT observation. If safety/tolerability are acceptable at the end of the DLT observation periods, the study will proceed to the next dose.
Cohort B - 3 patients at the 30 mg dose - will receive EOC202 administration in seriatim separated by four-week intervals for DLT observation. If safety/tolerability are acceptable at the end of the 4-week observation periods, the study will proceed to the next phase.
Cohort C will comprise of additional 6 patients as the PK dose expansion group based on the recommended dose for expansion (RDE). The study procedure is the same with the corresponding dose group.
All patients will participate in a pharmacokinetic (PK) and pharmacodynamic (PD) study which involves additional blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm EOC202 + Paclitaxol | Experimental | Biological: EOC202, Drug: PaclitaxelBiological: EOC202 This study is an open label, non-randomized, fixed dose-escalation phase I study, performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel (80 mg/m² at D1, D8 and D15 of every 4-week cycle). Two EOC202 dose levels (6 mg and 30 mg) will be evaluated in two cohorts of 18 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 48 weeks (12 s.c. injections in total), separated by 13-day intervals free of EOC202 administration. The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subject must be able to understand and willing to sign the informed consent form, and to complete the trial procedure and follow-up examinations;
- Female patients with histologically or cytologically confirmed metastatic breast cancer;
- Patients with HER-2 negative, including hormone receptor (HR) positive/HER-2 negative and triple negative breast cancer (TNBC);
- Age 18-70 years (including the critical value);
- Patients who are judged by investigators as suitable to receive paclitaxel first-line chemotherapy;
Key exclusion criteria (16 listed)
- Previous chemotherapy for metastatic breast cancer;
- Patients with recurrence of breast cancer within 6 months after the last dose of previous adjuvant chemotherapy;
- Inability to discontinue CYP isoenzyme inhibitor or inducer prohibited in the protocol 2 weeks before the first dose and during the trial;
- Patients with symptomatic central nervous system metastases;
- Abnormality on HBV serum tests (5 items) and HBV-DNA (+), anti-HCV antibody (+), HCV-RNA (+), anti-HIV antibody (+), or other serious infection requiring systemic therapy within 4 weeks prior to the first dose of investigational product;
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 | Arm EOC202 + Paclitaxol |
| PaclitaxelPaclitaxol will be IV injection | Drug | Arm EOC202 + Paclitaxol |
Primary outcome
DLT
Time frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 12 months
DLT and its incidence at each dose level
5 secondary outcomes
PFS
Time frame: up to 24 months
Cmax
Time frame: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
Tmax
Time frame: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
AUC 0-inf
Time frame: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
T1/2
Time frame: The time points for blood collection are prior to administration of EOC202 on Day 2 of Cycle 1and Day 2 of Cycle 4 and 1h, 2h, 4h, 8h, 24h, 48h, 72h, 144h, 192h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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, M.D. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EOC202 and Paclitaxel in people with Solid Tumor, Adult, run by Taizhou EOC Pharma Co., Ltd. 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 16 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: finished, as of the sponsor's last update on 31 Mar 2022. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 12 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 31 Mar 2022.