Clinical trial NCT05048134: A Phase I Study of HRS2300 or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
Official title: A Multi-center, Open-Label，Dose Escalation and Dose Expansion Phase I Study of HRS2300 Monotherapy or Combined With SHR-1316 or SHR-1701 or Trametinib or Almonertinib in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS2300 monotherapy or combined with SHR-1316, SHR-1701, trametinib, and Almonertinib
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Dose limited toxicity（DLT）
timeFrame: Cycle 1( 4 weeks- monotherapy；3 weeks -combination）
measure: Number of participants with adverse events
timeFrame: up to 3 years; at least once per treatment cycle
measure: Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy
timeFrame: through study completion，an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: