Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
Location status: Recruiting
Location contact
Binghe Xu
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05628870
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).
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Phase 1
Beijing, Beijing Municipality, 100021, China
Location status: Recruiting
Binghe Xu
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles.
Time frame: up to 28 days
Number of participants with dose-limiting toxicities (DLTs)
Time frame: up to 28 days
The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: Change From Baseline at 28 days
select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets
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
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Time frame: Up to approximately 1 year
Time frame: Up to approximately 1 year
Time frame: Up to approximately 1 year
Time frame: Up to approximately 1 year
Contact information is provided by the study sponsor or research team.
Shandong Suncadia Medicine Co., Ltd.
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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