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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05048134
Other study ID # HRS2300-I-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 25, 2021
Est. completion date March 30, 2025

Study information

Verified date November 2021
Source Jiangsu HengRui Medicine Co., Ltd.
Contact Yanjuan Liang, P.M
Phone +0518-82342973
Email yanjuan.liang@hengrui.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 345
Est. completion date March 30, 2025
Est. primary completion date January 2, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Aged 18-75 years old,Male or female; 2. Patients with pathologically confirmed advanced solid tumors who did not respond to standard treatment, did not tolerate standard treatment, or were determined by the investigator to be unsuitable for standard treatment; 3. ECOG PS score of 0-1; 4. Life expectancy of =3 months; 5. Able and willing to provide a written informed consent. Exclusion Criteria: 1. Receiving chemotherapy, targeted therapy, immunotherapy, radical radiotherapy or surgical treatment for less than 4 weeks before study therapy (excluding tyrosine kinase inhibitors or other small molecule targeted drugs < 2 weeks); Four weeks prior to the start of study treatment (patients who have entered the follow-up period measured by the time of last use of the experimental drug or device) were enrolled in another clinical study; 2. Drugs that affect the activity of metabolic enzyme CYP3A have been used in the past, and the eluting period from the end time to the first administration in this study is within 5 half-lives; 3. Patients with active TB within 1 year prior to the start of drug therapy or with a history of active TB infection more than 1 year prior to the start of drug therapy without proper treatment were studied; 4. Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HRS2300
HRS2300 monotherapy
HRS2300? SHR-1316
HRS2300 combined with SHR-1316
HRS2300?SHR-1701
HRS2300 combined with SHR-1701
HRS2300?trametinib
HRS2300 combined with trametinib
HRS2300?Almonertinib
HRS2300 combined with Almonertinib

Locations

Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with Dose limited toxicity(DLT) Cycle 1( 4 weeks- monotherapy;3 weeks -combination)
Primary Number of participants with adverse events up to 3 years; at least once per treatment cycle
Primary Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data. through study completion,an average of 2 years
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