Phase I Study of FXS887 in the Treatment of Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
About this trial
This is a single-arm, open-label, dose-escalation and dose-expansion Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of FXS887 in patients with advanced solid tumors. FXS887 is a innovative ATR inhibitors of a class of small-molecule inhibitors targeting ATR kinase.
Eligibility criteria
Qualifiers
Aged ≥ 18 years, male or female;
Participants must fully understand the requirements of the study and voluntarily sign the written informed consent;
Participants with histologically/cytologically confirmed advanced solid tumors who have received ≥ 1 line of systemic therapy prior to enrollment in the study and experienced failure of standard therapy (disease progression or intolerance);
Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, participants must have at least one measurable target lesion;
Disqualifiers
Within the washout period of prior anti-tumor medication treatment (4 weeks or 5 half-lives after the last dose, whichever is longer) prior to the first dose of FXS887;
Have participated in another clinical study within 4 weeks prior to the first dose of FXS887;
Have a history of hypersensitivity to any known components of FXS887 or its analogues;
Have intolerance to ATR inhibitors or have received ATR inhibitors within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of FXS887;
Trial design
Treatments tested in this trial
- FXS887
Treatment groups
14 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov