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Phase I Study of FXS887 in the Treatment of Solid Tumors

ConditionSolid Tumor Refractory to Conventional Treatment
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • FXS887

    Drug

    FXS887 is an innovative ATR inhibitor targeting ATR kinase.

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: FXS887Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with DLTs

DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined DLT criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (28 days) of treatment.

Time frame
Up to Day 28
2

Maximum tolerated dose (MTD) or Maximum administered dose(MAD)

The MTD is defined as the highest dose level at which the proportion of subjects who experience Dose-Limiting Toxicity (DLT) is less than 1/3 during the DLT observation period. If the MTD is not established after the completion of the dose-escalation, the highest safe dose level will be defined as the MAD.

Time frame
Up to 12 Months
3

Incidence of Treatment-Emergent Adverse Events (TEAEs)[Safety and Tolerability]

Number and frequency of subjects with adverse events, including changes in vital signs, electrocardiograms (ECGs), physical examinations, and laboratory parameters, graded according to NCI CTCAE v5.0.

Time frame
From first dose of study drug until 30 days after the last dose.
4

Phase 1a: recommended phase 2 dose (RP2D)

The RP2D (Recommended Phase 2 Dose) determined based on comprehensive consideration of safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics), and efficacy data.

Time frame
Up to 12 Months

Secondary outcomes

1

Peak Plasma Concentration (Cmax) of FXS887

Maximum observed plasma concentration of FXS887 following single and multiple doses.

Time frame
From the day of first dose to 30 days after last dose of FXS887
2

Area under the plasma concentration-time curve (AUC)of FXS887

The area under the plasma concentration-time curve of FXS887 following single and multiple doses.

Time frame
From the day of first dose to 30 days after last dose of FXS887
3

Time to reach maximum plasma concentration (Tmax) of FXS887

Time to reach maximum plasma concentration of FXS887 following single and multiple doses.

Time frame
From the day of first dose to 30 days after last dose of FXS887
4

Elimination Half-Life (t1/2) of FXS887

Apparent terminal elimination half-life of FXS887 in plasma.

Time frame
From the day of first dose to 30 days after last dose of FXS887

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: