Metastatic or Local Advanced Breast Cancer of PatientsPhase 1NCT05189717

A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults

A Phase 1 study testing HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus in people with Metastatic or Local Advanced Breast Cancer of Patients, run by Shandong Suncadia Medicine Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Metastatic or Local Advanced Breast Cancer of Patients
What is being tested?: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 2 sitesChina
Study dates: 17 Feb 2022to 31 Jul 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

ECOG performance status score: 0-1;
Histopathologically documented local advanced or metastatic breast cancer ;
Female of not childbearing potential must the related requirement;
During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
Adequate organ functions as defined;
Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Who cannot join

For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
History of clinically significant cardiovascular or cerebrovascular diseases;
The subject has one of many factors affecting oral drugs;
Active infection or fever with unknown cause > 38.5 °C;
Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
Known history of allergy to study drug ingredients.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Fifth Medical Center of People's Liberation Army of China General Hospital
Beijing, Beijing Municipality, 100071
Jilin Cancer Hospital
Changchun, Jilin, 130012

Other trials in China

About this study

Official title: A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer

Conditions: Metastatic or Local Advanced Breast Cancer of Patients
Being tested: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、EverolimusDrug
During HRS-8080 monotherapy period, the dose of HRS-8080 would be increasing. In the combination therapy period, HRS-8080 will be administered at flat dose of RP2D-1 and RP2D.

Study groups in NCT05189717
Study group	Role	What they receive
Single Group	Experimental	Firstly Dose Escalation and Dose Expansion of HRS-8080 monotherapy should be conducted. After RP2D and MTD of the HRS-8080 monotherapy were confirmed, Dose Escalation and Dose Extension of HRS-8080 in combination with other anti-cancer treatment would be completed, including SHR 6390, or Abemaciclib, or Everolimus. Receives: Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum tolerated dose
The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Measured: up to 28 days
Recommended phase II dose
The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Measured: up to 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 (13)

Cmax
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Tmax
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus. etc.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
AUC0-t
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Cmax,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Tmax,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Cmin,ss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
AUCss
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Rac
PK parameters of multiple doses of HRS-8080 monotherapy. HRS-8080 in combination therapy, SHR-6390, Abemaciclib and Everolimus.
Measured: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
ORR
Objective Response Rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Measured: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
BOR
Best Overall Response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Measured: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
DoR
Duration of response, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Measured: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
DCR
Disease control rate, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Measured: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
PFS
Progression-free survival, Preliminary Efficacy endpoints of HRS-8080 monotherapy or in combination with SHR-6390, Abemaciclib or Everolimus in treatment of patients with metastatic or local advanced breast cancer
Measured: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202231 Jul 2025

First posted12 Jan 2022
Study start17 Feb 2022
Primary completion31 Oct 2024 (estimated)
Study completion31 Jul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic or Local Advanced Breast Cancer of PatientsStudies 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: HRS-8080 tablets monotherapy and combined with other anti-cancer therapy
Masking: None (open label)
Enrolment: 156 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05189717
Sponsor's protocol ID: HRS-8080-I-101
Status last verified: Apr 2022
First submitted: 16 Dec 2021
Last updated: 5 Apr 2022
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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer
ClinicalTrials.gov ID: NCT05189717
Acronym / sponsor ID: HRS-8080-I-101
Conditions: Metastatic or Local Advanced Breast Cancer of Patients
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 156 participants (estimated)
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 17 Feb 2022 (actual)
Primary completion: 31 Oct 2024 (estimated)
Study completion: 31 Jul 2025 (estimated)
First posted: 12 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: HRS-8080 tablets monotherapy and combined with other anti-cancer therapy

Arm	Type	Receives
Single Group	Experimental	Drug: HRS-8080 tablets、SHR 6390 tablets、Abemaciclib、EverolimusFirstly Dose Escalation and Dose Expansion of HRS-8080 monotherapy should be conducted. After RP2D and MTD of the HRS-8080 monotherapy were confirmed, Dose Escalation and Dose Extension of HRS-8080 in combination with other anti-cancer treatment would be completed, including SHR 6390, or Abemaciclib, or Everolimus.

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)

ECOG performance status score: 0-1;
Histopathologically documented local advanced or metastatic breast cancer ;
Female of not childbearing potential must the related requirement;
During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
Adequate organ functions as defined;

Key exclusion criteria (7 listed)

For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
History of clinically significant cardiovascular or cerebrovascular diseases;
The subject has one of many factors affecting oral drugs;
Active infection or fever with unknown cause > 38.5 °C;

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-8080 tablets、SHR 6390 tablets、Abemaciclib、EverolimusDuring HRS-8080 monotherapy period, the dose of HRS-8080 would be increasing. In the combination therapy period, HRS-8080 will be administered at flat dose of RP2D-1 and RP2D.	Drug	Single Group

Primary outcome

Maximum tolerated dose
Time frame: up to 28 days
The Maximum tolerated dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
Recommended phase II dose
Time frame: up to 28 days
The Recommended phase II dose of HRS-8080 monotherapy or in combination with SHR-6390 / Abemaciclib / Everolimus
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

13 secondary outcomes

Cmax
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Tmax
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth 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 fifth 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 fifth 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 fifth 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 fifth treatment period
AUCss
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
Rac
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
ORR
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
BOR
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
DoR
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
DCR
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
PFS
Time frame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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?

Maximum tolerated dose (time frame: up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05189717.

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 5 Apr 2022.