Phase I Study of FXS887 in the Treatment of Solid Tumors (NCT07345637) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Study of FXS887 in the Treatment of Solid Tumors
China14 participantsStarted 2026-01-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
✓. Estimated life expectancy of ≥ 12 weeks;
✓. Participants must have adequate organ and bone marrow function.
✓. For female participants of childbearing age, the serum pregnancy test within 7 days prior to the first dose of the study drug must be negative; eligible participants of reproductive potential (both males and females) must agree to use reliable contraceptive methods (hormonal, barrier, abstinence, etc.) with their partners during the study period and for at least 6 months after the last dose of the study drug.
Exclusion criteria
✕. 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;
What they're measuring
1
Number of participants with DLTs
Timeframe: Up to Day 28
2
Maximum tolerated dose (MTD) or Maximum administered dose(MAD)
Timeframe: Up to 12 Months
3
Incidence of Treatment-Emergent Adverse Events (TEAEs)[Safety and Tolerability]
Timeframe: From first dose of study drug until 30 days after the last dose.
4
Phase 1a: recommended phase 2 dose (RP2D)
Timeframe: Up to 12 Months
Trial details
NCT IDNCT07345637
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
✕. 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;
✕. Need to take strong CYP3A inhibitors and/or inducers, as well as P-gp (P-glycoprotein) inhibitors and/or inducers within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of FXS887 and during the study period;
✕. Need to take drugs known to prolong the QTc interval during the study period;
✕. Have had other malignant tumors within 2 years prior to the first dose of FXS887, except for local tumors that have been cured and judged by the investigator to have a low risk of recurrence;
✕. Have received radiation therapy within 14 days prior to the first dose of FXS887;