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NCT07596381

FAK Inhibitor in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 7 months later.

See at-risk trials from InxMed (Shanghai) Co., Ltd.

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 28, 2027 to Sep 30, 2027 Show 6 more changesShow less
    • Recruitment opened
    • Eligibility criteria expanded, about 24 words
    • Start date changed from estimate of May 30, 2026 to May 11, 2026
    • Secondary endpoints: details revised at 5 of 24 entries
    • Study description revised
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

To explore the incidence of dose-limiting toxicities (DLTs) of IN10028, identify the maximum tolerated dose (MTD), and determine the recommended phase 2 dose (RP2D).
Timeframe: Approximately 6 months

Secondary (24)

PK:AUC0-24h of IN10028
PK: AUC0-t of IN10028
PK: AUC0-∞ of IN10028
PK: AUCextrap(%) of IN10028
PK: Cmax of IN10028
Show 19 moreShow less
PK: Tmax of IN10028
PK: t1/2 of IN10028
PK: λz of IN10028
PK: Vz/F of IN10028
PK: CL/F of IN10028
PK: Cmax,ss of IN10028
PK: Cmin,ss of IN10028
PK: Cav,ss of IN10028
PK: AUC0-tau of IN10028
PK: CLss/F of IN10028
PK: Vz,ss/F of IN10028
PK: Flu% of IN10028
PK: Rac of IN10028
To evaluate the rate of Objective Response Rate (ORR) of IN10028 in solid tumors.
To evaluate the time of Duration of Response (DoR) of IN10028 in solid tumors.
To evaluate the rate of Disease Control Rate (DCR) of IN10028 in solid tumors.
To evaluate the Time To Response (TTR) of IN10028 in solid tumors.
To evaluate the duration of Progression-free Survival (PFS) of IN10028 in solid tumors.
To Evaluate the duration of Overall survival (OS) of IN10028 in solid tumors.

Arms and interventions

IN10028Experimental

The monotherapy dose-escalation will adopt an accelerated titration design combined with the conventional 3+3 dose-escalation method. The starting dose of IN10028 is 25 mg, with a total of 5 planned dose cohorts: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg, administered orally once daily (QD) continuously.The DLT observation period is 14 days at the 25 mg dose level, and 21 days at the 50 mg, 100 mg, 200 mg and 300 mg dose levels, respectively.

Drugs: IN10028

Sites

1 site in 1 country

  • Zhejiang Cancer HospitalHangzhou, Zhejiang, China