Breast CancerPhase 1NCT05673694
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
A Phase 1 study testing EG017 in people with Breast Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- EG017
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesChina
- Study dates
- 8 Mar 2023to 2 Jan 2026
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, 18-75 years old;
- Expected survival ≥ 12 weeks;
- Subjects with ECOG score of physical state 0~1;
- Histologically confirmed recurrent or metastatic advanced breast cancer;
Who cannot join
- Those who have had a severe allergic reaction to any drug or its components in this study in the past;
- Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
- Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
- Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Cancer Hospital of CAMS
Beijing, Benjing, 100020
Binghe Xu, Doctor, +86-10-87788826, xubinghe@medmail.com.cn
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430000
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EG017 in Androgen Receptor-positive, Estrogen Receptor-positive, and Human Epidermal Growth Factor Receptor-2-negative Patients With Advanced Breast Cancer.
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
Read the detailed description
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
- Conditions
- Breast Cancer
- Being tested
- EG017
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG017Drug
According to the dosage group of the program, once a day.
| Study group | Role | What they receive |
|---|---|---|
| EG017 | Experimental | 70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days. Receives: Drug: EG017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
The CTCAE criteria will be used to assess adverse events on this trial.
Measured: 28 Days
The effectiveness of EG017 in humans was evaluated by clinical benefit rate
The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start8 Mar 2023
- Primary completion7 Nov 2025 (estimated)
- Study completion2 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673694
- Sponsor's protocol ID
- EG017
- Status last verified
- Dec 2023
- First submitted
- 30 Dec 2022
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EG017 in Androgen Receptor-positive, Estrogen Receptor-positive, and Human Epidermal Growth Factor Receptor-2-negative Patients With Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT05673694
- Acronym / sponsor ID
- EG017
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 7 Nov 2025 (estimated)
- Study completion
- 2 Jan 2026 (estimated)
- First posted
- 6 Jan 2023 (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.
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
Detailed description
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EG017 | Experimental | Drug: EG01770 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days. Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, 18-75 years old;
- Expected survival ≥ 12 weeks;
- Subjects with ECOG score of physical state 0~1;
- Histologically confirmed recurrent or metastatic advanced breast cancer;
Key exclusion criteria (4 listed)
- Those who have had a severe allergic reaction to any drug or its components in this study in the past;
- Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
- Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
- Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
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 |
|---|---|---|
| EG017According to the dosage group of the program, once a day. | Drug | EG017 |
Primary outcome
Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
Time frame: 28 Days
The CTCAE criteria will be used to assess adverse events on this trial.
The effectiveness of EG017 in humans was evaluated by clinical benefit rate
Time frame: 24 Weeks
The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EG017 in people with Breast Cancer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 5 sites 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 4 inclusion and 4 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 14 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 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang (+86 18201085833, wangwei13@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs). (time frame: 28 Days). 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 14 Dec 2023.