Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChipscreen Biosciences, Ltd.
About this trial
This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period.
The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Understand and sign the informed consent form voluntarily.
≥18 years old when signing the informed consent, regardless of sex.
Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cell lung cancer, glioblastoma, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer) for which standard therapy has failed or was intolerable, and currently no standard treatment is available.
Radiological or histopathological evidence indicating disease progression should be documented.
Disqualifiers
Received any form of intracranial radiotherapy within 3 months prior to the first dose.
Received any anti-tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, cellular therapy, radiation therapy [see exclusion criterion #1 for head], endocrine anti-tumor therapy, tumor embolization) or unapproved investigational drugs or devices within 28 days prior to the first dose. Also, received Traditional Chinese Medicine (TCM) approved by the National Medical Products Administration (NMPA) for treating malignant tumors within 14 days prior to the first dose.
Previously received Aurora kinase inhibitors.
Used strong inducers or inhibitors of cytochrome P450 3A (CYP3A) enzymes within 14 days prior to the first dose or are still within 7 half-lives of such drugs (whichever is longer).
Trial design
Design model
Sequential
Treatments tested in this trial
CS231295
Drugoral tablet. Only one dose on C0D1 in single-dose period. Once daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases.
Treatment groups
102 Participants
are divided into 1 treatment groupGroup A: CS231295Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
incidence of dose-limiting toxicity (DLT)
Time frame
34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose2
maximum tolerated dose (MTD)
Time frame
dose escalation part, about 2 years3
incidence of adverse events (AEs)
Number of participants with AE(s)
Time frame
from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first4
Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)
Time frame
during treatment, up to 11 cycles, 28 days in one cycleSecondary outcomes
1
Objective Response Rate (ORR)
Time frame
during study, expected average one year2
Disease control rate (DCR)
Time frame
during study, expected average one year3
Duration of Response (DOR)
Time frame
during study, expected average one year4
Time to Progression (TTP)
Time frame
during study, expected average one yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov