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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT05048134
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HRS2300 — DRUG
    HRS2300 monotherapy
  • HRS2300、 SHR-1316 — DRUG
    HRS2300 combined with SHR-1316
  • HRS2300、SHR-1701 — DRUG
    HRS2300 combined with SHR-1701
  • HRS2300、trametinib — DRUG
    HRS2300 combined with trametinib
  • HRS2300、Almonertinib — DRUG
    HRS2300 combined with Almonertinib

Study Details

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.

Key Dates

Start date
Oct 25, 2021
Status verified
Sep 2024
Primary completion
Feb 24, 2023
Completion
May 23, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
  • Experimental: Treatment group B
  • Experimental: Treatment group C
  • Experimental: Treatment group D
  • Experimental: Treatment group E

Primary Outcome Measure

Number of participants with Dose limited toxicity（DLT） [ Time Frame: Cycle 1( 4 weeks- monotherapy；3 weeks -combination） ]

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