Not yet recruitingNCT07596381Updated May 19, 2026

FAK Inhibitor in Patients With Advanced Solid Tumors

A Phase 1 interventional study of IN10028 in Advanced Solid Tumors, sponsored by InxMed (Shanghai) Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by InxMed (Shanghai) Co., Ltd. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 75
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is A Phase I/Ib Study，aimed to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of Focal Adhesion Kinase Inhibitor IN10028 as Monotherapy and Combination Therapy in Patients with Advanced Solid Tumors.

Read the detailed description

Same-target drugs of IN10028 include Ifebemtinib (a first-generation focal adhesion kinase [FAK] inhibitor), defactinib (Verastem Oncology), VS-4748 (Verastem Oncology), and GSK2256098 (GlaxoSmithKline [GSK] plc). IN10028 is a potent, highly selective, orally available second-generation focal adhesion kinase (FAK, also known as protein tyrosine kinase 2 [PTK2]) inhibitor . It binds to the kinase domain of FAK to block activation of downstream oncogenic PI3K/AKT and RAS/MAPK signaling pathways, thus suppressing tumor cell proliferation, inducing apoptosis, and markedly attenuating tumor cell migration and invasion.Based on the clinically validated target value of the first-generation FAK inhibitor Ifebemtinib (Ifebe, IN10018, original development code BI 853520) and its associated limitation of proteinuria, IN10028 has been specifically optimized to achieve more potent target inhibition and a potentially superior safety profile. Given the well-established clinical value of the FAK target and successful clinical experience with other same-target agents,there is a robust, well-supported clinical development rationale for IN10028.

A Phase I/Ib clinical trial is planned by the sponsor to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of FAK inhibitor IN10028 as monotherapy and in combination with other anticancer agents in patients with advanced solid tumors.

Conditions studied

Advanced Solid Tumors

In context

Lead sponsor

InxMed (Shanghai) Co., Ltd. is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Able to understand and voluntarily sign the written Informed Consent Form (ICF), which must be signed prior to conducting the study-specific procedures required by the trial.
At the time of signing the ICF, subjects are aged 18 to 75 years, inclusive, male and female.
Subjects must have a histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumor.Monotherapy dose-escalation and dose expansion: Patients with solid tumors who failed prior standard systemic therapy, have no standard treatment options, or are intolerant to standard regimens.
Prior systemic antitumor therapy must be completed at least 3 weeks before the first study drug treatment; prior small molecule TKIs or oral fluoropyrimidines require a minimum 2-week washout period.
Subjects must have at least one measurable tumor lesion per RECIST v1.1. Previously irradiated lesions should not be selected as target lesions, unless such irradiated lesion is the only measurable lesion and has documented radiological disease progression, and may then be selected as a target lesion.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Subjects have an estimated expected survival time of at least 3 months.
Has adequate organ function.
Urine protein negative or trace (±); or urine protein 1+, but urine protein to creatinine ratio (UPCR) of random morning urine \< 0.5, or 24-hour urine protein quantitation \< 0.5 g/24 h.
Female subjects of childbearing potential must have a negative serum pregnancy test and agree to use effective contraception during the study drug treatment period and for 120 days after the last dose of study drug administration. Male subjects with female partners of childbearing potential must agree to use effective contraception during the study drug treatment period and for 120 days after the last dose of study drug administration. In this protocol, a woman of childbearing potential is defined as a sexually mature female.

Exclusion criteria

Exclusion Criteria:

Subjects unable to receive oral administration or with conditions that severely affect drug digestion and absorption (e.g., subtotal gastrectomy or duodenectomy, severe sinus tract affecting digestion and absorption, and other related diseases.
Subjects with known central nervous system (CNS) metastases, excluding those with asymptomatic CNS metastases or asymptomatic brain metastases following prior treatment, provided that the lesions have been confirmed to be stable for more than 3 months by computed tomography (CT) or magnetic resonance imaging (MRI), and no steroid therapy has been required for at least 4 weeks.
Subjects with known hypersensitivity to any components of the study drug or its analogues.
Subjects with prior treatment of focal adhesion kinase inhibitors (FAKi).
Subjects with a history of any other malignancy within 5 years prior to screening, excluding cured cervical carcinoma in situ and completely resected basal cell carcinoma of the skin.
Subjects with uncontrolled cardiac clinical symptoms or diseases, including:(1) Heart failure classified as New York Heart Association (NYHA) Class Ⅱ or above; (2) unstableangina; (3) Myocardial infarction within the past 1 year;(4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) Corrected QT interval (QTc) > 450 ms in males and QTc > 470 ms in females. The QTc interval is calculated using Fridericia's correction formula: QTcF = QT/(RR\^0.33); (6) Left ventricular ejection fraction (LVEF) \< 50%.
Subjects with known hereditary or acquired bleeding and thrombotic predispositions (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.)
Subjects with an active infection within 4 weeks prior to enrollment, or those with other chronic medical conditions deemed unsuitable for study participation by the Investigator.
Subjects with congenital or acquired immunodeficiency disorders (e.g., human immunodeficiency virus [HIV] infection), or those with a history of organ transplantation.
Hepatitis B surface antigen (HBsAg) positive with hepatitis B virus DNA (HBV DNA) ≥ 2500 copies/mL (or 500 IU/mL); or positive for hepatitis C virus RNA (HCV RNA).
Have received a live vaccine within 30 days prior to the first dose of administration.
Women of childbearing potential who are pregnant-planning or lactating.
Subjects who are inability to comply with protocol requirements or who is otherwise considered unsuitable for study participation by the investigator's judgment.
Subjects receiving concomitant intravenous or oral medications that affect CYP isoenzymes (strong inducers or strong inhibitors of CYP3A4), or who have used such medications within at least 1 week prior to the first dose of administration.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 75 participants (estimated)

Study arms

Experimental
IN10028
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.
Drug: IN10028

Interventions

DrugIN10028
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 with a cycle of 21 days.

What researchers measure

Primary outcomes

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).
To evaluate the safety and tolerability of IN10028 in patients with advanced malignant solid tumors, characterize the incidence of dose limiting toxicities (DLTs), identify the maximum tolerated dose (MTD), and determine the recommended phase 2 dose (RP2D).
Time frame: Approximately 6 months

Secondary outcomes

PK:AUC0-24h of IN10028
To evaluate area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24h) profile following single- and multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: AUC0-t of IN10028
To evaluate the area under the plasma concentration-time curve from 0 to the last measurable time point (AUC₀-t) profile following single- and multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: AUC0-∞ of IN10028
To evaluate area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞) profile following single-dose and multiple-dose dosing of IN10028.
Time frame: Approximately 6 months
PK: AUCextrap(%) of IN10028
To evaluate percent of aucinf attributed to extrapolation (AUCextrap(%) )profile following single-dose and multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Cmax of IN10028
Maximum plasma concentration (Cmax) profile following single-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Tmax of IN10028
Time to reach maximum plasma concentration (Tmax) profile following single-dose administration of IN10028.
Time frame: Approximately 6 months
PK: t1/2 of IN10028
Elimination half-life (t1/2) profile following single-dose and multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: λz of IN10028
Terminal elimination rate constant (λz) profile following single-dose and multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Vz/F of IN10028
Apparent volume of distribution during the terminal phase（Vz/F) following single-dose administration of IN10028.
Time frame: Approximately 6 months
PK: CL/F of IN10028
Apparent total clearance during the elimination phase（CL/F) following single-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Cmax,ss of IN10028
To evaluate the maximum steady-state plasma drug concentration（Cmax,ss）following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Cmin,ss of IN10028
To evaluate the minimum steady-state plasma drug concentration（Cmin,ss）following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Cav,ss of IN10028
To evaluate the average steady-state plasma drug concentration（Cav,ss）following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: AUC0-tau of IN10028
To evaluate the time-concentration curve from time zero to the end of the dosing interval (tau)（AUC0-tau）following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: CLss/F of IN10028
To evaluate the apparent total clearance at steady state (CLss/F) following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Vz,ss/F of IN10028
To evaluate the apparent steady-state volume of distribution during the terminal phase (Vz,ss/F) following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Flu% of IN10028
To evaluate the percentage of fluctuation at steady state (Flu%) following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
PK: Rac of IN10028
To evaluate the percent fluctuation at steady state (Rac) following the multiple-dose administration of IN10028.
Time frame: Approximately 6 months
To evaluate the rate of Objective Response Rate (ORR) of IN10028 in solid tumors.
Defined as the proportion of subjects with complete response (CR) or partial response (PR).
Time frame: Approximately 1 year
To evaluate the time of Duration of Response (DoR) of IN10028 in solid tumors.
Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.
Time frame: Approximately 1 year
To evaluate the rate of Disease Control Rate (DCR) of IN10028 in solid tumors.
Defined as the proportion of patients with CR, PR, or stable disease (SD).
Time frame: Approximately 1 year
To evaluate the Time To Response (TTR) of IN10028 in solid tumors.
To preliminarily evaluate the antitumor activity of IN10028 time to response (TTR).
Time frame: Approximately 1 year
To evaluate the duration of Progression-free Survival (PFS) of IN10028 in solid tumors.
Defined as the time from the first dose of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Time frame: Approximately 1 year
To Evaluate the duration of Overall survival (OS) of IN10028 in solid tumors.
Defined as the time from the first dose of study treatment to the date of death due to any cause.
Time frame: Approximately 1 year

Study locations

1 site

Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310005, China
- zhengbo song Chief Physician, MD · Contact · songzb@zjcc.org.cn · 86-13857153345

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07596381
Lead sponsor: InxMed (Shanghai) Co., Ltd.
Collaborators: InxMed (Nanjing) Co., Ltd.
Responsible party: Sponsor
First posted: May 19, 2026
Start date: May 30, 2026 (estimated)
Primary completion: Feb 28, 2027 (estimated)
Completion: Feb 28, 2028 (estimated)
Last update: May 19, 2026

Study contacts

xiaofang liu Project Manager, Bachelor

Contact

xiaofang.liu@inxmed.com

86+13308303078

jack zhang Clinical Trial Manager, bachelor

Contact

jack.zhang@inxmed.com

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

InxMed (Shanghai) Co., Ltd.

Start the discussion