Breast CancerPhase 1NCT05628870
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
A Phase 1 study testing HRS-1358 in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-1358
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2023to 30 Jun 2025
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically diagnosis of local advanced or metastatic breast cancer
- Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
- At least 1 line of endocrine therapy in the metastatic or advanced setting
- ECOG performance status score: 0-1;
- Adequate organ functions as defined
- Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.
Who cannot join
- the investigators judged that it was not suitable to endocrine therapy
- patients with active brain metastasis (without medical control or with clinical symptoms),
- History of clinically significant cardiovascular or cerebrovascular diseases
- The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
- Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
- Have received other similar drugs in the past;
- Known history of allergy to HRS-1358 ingredients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Binghe Xu
About this study
Official title: A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy or Combination With Dalpiciclib Isethionate Tablets in Patients With Metastatic or Locally Advanced Breast Cancer.
The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
- Conditions
- Breast Cancer
- Being tested
- HRS-1358
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1358Drug
HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1358 | Experimental | Daily oral dosages of HR-1358； Daily oral dosages of HR-1358 and Dalpiciclib Isethionate Tablets Receives: Drug: HRS-1358 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicities (DLTs)
Number of participants with dose-limiting toxicities (DLTs)
Measured: up to 28 days
Maximum tolerated dose
The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: up to 28 days
RP2D
select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets
Measured: Change From Baseline at 28 days
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: up to 30 days after the last dose
Secondary outcomes (12)
Cmax
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Tmax
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
AUC0-t
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Cmax,ss
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Tmax,ss
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Cmin,ss
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
AUCss
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Rac
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Overall response rate (ORR) in participants
Measured: Up to approximately 1 year
Clinical benefit rate (CBR) in participants
Measured: Up to approximately 1 year
Duration of response (DOR) in participants
Measured: Up to approximately 1 year
Progression Free Survival (PFS) observed in participants
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start7 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completion30 Jun 2025 (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 Shandong Suncadia Medicine 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
- Model description
- Single arm study of HRS-1358
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628870
- Sponsor's protocol ID
- HRS-1358-I-101
- Status last verified
- Aug 2024
- First submitted
- 17 Nov 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy or Combination With Dalpiciclib Isethionate Tablets in Patients With Metastatic or Locally Advanced Breast Cancer.
- ClinicalTrials.gov ID
- NCT05628870
- Acronym / sponsor ID
- HRS-1358-I-101
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Nov 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.
The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study of HRS-1358
| Arm | Type | Receives |
|---|---|---|
| HRS-1358 | Experimental | Drug: HRS-1358Daily oral dosages of HR-1358； Daily oral dosages of HR-1358 and Dalpiciclib Isethionate Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically diagnosis of local advanced or metastatic breast cancer
- Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
- At least 1 line of endocrine therapy in the metastatic or advanced setting
- ECOG performance status score: 0-1;
- Adequate organ functions as defined
Key exclusion criteria (7 listed)
- the investigators judged that it was not suitable to endocrine therapy
- patients with active brain metastasis (without medical control or with clinical symptoms),
- History of clinically significant cardiovascular or cerebrovascular diseases
- The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
- Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
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 |
|---|---|---|
| HRS-1358HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles. | Drug | HRS-1358 |
Primary outcome
Dose Limited Toxicities (DLTs)
Time frame: up to 28 days
Number of participants with dose-limiting toxicities (DLTs)
Maximum tolerated dose
Time frame: up to 28 days
The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
RP2D
Time frame: Change From Baseline at 28 days
select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Time frame: up to 30 days after the last dose
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
12 secondary outcomes
Cmax
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Tmax
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
AUC0-t
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Cmax,ss
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Tmax,ss
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Cmin,ss
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
AUCss
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Rac
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Overall response rate (ORR) in participants
Time frame: Up to approximately 1 year
Clinical benefit rate (CBR) in participants
Time frame: Up to approximately 1 year
Duration of response (DOR) in participants
Time frame: Up to approximately 1 year
Progression Free Survival (PFS) observed in participants
Time frame: Up to approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- 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. This study is not recruiting at the moment.
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 HRS-1358 in people with Breast Cancer, run by Shandong Suncadia Medicine 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 6 inclusion and 7 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 17 Mar 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xia Zhang (+0518-81220121, Xia.zhang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicities (DLTs) (time frame: up to 28 days). The study lists 4 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 17 Mar 2025.