FAK Inhibitor in Patients With Advanced Solid Tumors

NCT07596381 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: IN10028-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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).

  Approximately 6 months

Secondary Outcomes (24)

• PK:AUC0-24h of IN10028

  Approximately 6 months

• PK: AUC0-t of IN10028

  Approximately 6 months

• PK: AUC0-∞ of IN10028

  Approximately 6 months

• PK: AUCextrap(%) of IN10028

  Approximately 6 months

• PK: Cmax of IN10028

  Approximately 6 months

Study Arms (1)

IN10028

EXPERIMENTAL

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

IN10028 DRUG

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.

IN10028

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead
• InxMed (Nanjing) Co., Ltd.: collaborator

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

Central Study Contacts

xiaofang liu Project Manager, Bachelor

CONTACT

86+13308303078; xiaofang.liu@inxmed.com

jack zhang Clinical Trial Manager, bachelor

CONTACT

jack.zhang@inxmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)