A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
About this trial
A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors..
At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
Adult cohort: ECOG PS score of 0-1;
Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) PS score > 60.
Disqualifiers
Any other active malignancy within 5 years prior to the first dose of the study drug.
Prior anti-cancer treatment within 28 days prior to the first dose.
Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation.
Trial design
Design model
Single group
Treatments tested in this trial
ICP-723
DrugICP-723 is a white, round, uncoated table
Treatment groups
310 Participants
are divided into 1 treatment groupGroup A: ICP-723Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To evaluate the safety and tolerability of ICP-723 at different doses in the treatment of advanced solid tumors;
Time frame
Up to 12 months2
MTD
To determine maximum tolerated dose (MTD)
Time frame
Up to 2 MonthsSecondary outcomes
1
Cmax
To preliminarily obtain pharmacokinetic (PK) data of ICP-723 in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)
Time frame
Up to 1 month2
ORR
Objective Response Rate
Time frame
Up to 2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov