A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies

  • End date
    Mar 30, 2025
  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 10 November 2021


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.

Condition Advanced Malignancies
Treatment HRS2300, HRS2300、 SHR-1316, HRS2300、SHR-1701, HRS2300、trametinib, HRS2300、Almonertinib
Clinical Study IdentifierNCT05048134
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on10 November 2021


Yes No Not Sure

Inclusion Criteria

Aged 18-75 years oldMale or female
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
ECOG PS score of 0-1
Life expectancy of 3 months
Able and willing to provide a written informed consent

Exclusion Criteria

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
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
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
Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator
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