Advanced Solid TumorsPhase 1NCT07596381
FAK Inhibitor in Patients With Advanced Solid Tumors
A Phase 1 study testing IN10028 in people with Advanced Solid Tumors, run by InxMed (Shanghai) Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IN10028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 28 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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%.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
jack zhang Clinical Trial Manager, bachelor contact
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
zhengbo song Chief Physician, MD, 86-13857153345, songzb@zjcc.org.cn
About this study
Official title: A Phase I/Ib Study 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
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
- Advanced Solid Tumors
- Being tested
- IN10028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN10028Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: IN10028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approximately 6 months
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 6 months
PK: Cmax of IN10028
Maximum plasma concentration (Cmax) profile following single-dose administration of IN10028.
Measured: Approximately 6 months
PK: Tmax of IN10028
Time to reach maximum plasma concentration (Tmax) profile following single-dose administration of IN10028.
Measured: Approximately 6 months
PK: t1/2 of IN10028
Elimination half-life (t1/2) profile following single-dose and multiple-dose administration of IN10028.
Measured: Approximately 6 months
PK: λz of IN10028
Terminal elimination rate constant (λz) profile following single-dose and multiple-dose administration of IN10028.
Measured: Approximately 6 months
PK: Vz/F of IN10028
Apparent volume of distribution during the terminal phase（Vz/F) following single-dose administration of IN10028.
Measured: Approximately 6 months
PK: CL/F of IN10028
Apparent total clearance during the elimination phase（CL/F) following single-dose administration of IN10028.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 6 months
PK: Flu% of IN10028
To evaluate the percentage of fluctuation at steady state (Flu%) following the multiple-dose administration of IN10028.
Measured: Approximately 6 months
PK: Rac of IN10028
To evaluate the percent fluctuation at steady state (Rac) following the multiple-dose administration of IN10028.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start30 May 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- InxMed (Nanjing) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596381
- Sponsor's protocol ID
- IN10028-001
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study 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
- ClinicalTrials.gov ID
- NCT07596381
- Acronym / sponsor ID
- IN10028-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- InxMed (Nanjing) Co., Ltd.
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IN10028 | Experimental | Drug: IN10028The 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN10028The 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. | Drug | IN10028 |
Primary outcome
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).
Time frame: Approximately 6 months
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).
24 secondary outcomes
PK:AUC0-24h of IN10028
Time frame: Approximately 6 months
PK: AUC0-t of IN10028
Time frame: Approximately 6 months
PK: AUC0-∞ of IN10028
Time frame: Approximately 6 months
PK: AUCextrap(%) of IN10028
Time frame: Approximately 6 months
PK: Cmax of IN10028
Time frame: Approximately 6 months
PK: Tmax of IN10028
Time frame: Approximately 6 months
PK: t1/2 of IN10028
Time frame: Approximately 6 months
PK: λz of IN10028
Time frame: Approximately 6 months
PK: Vz/F of IN10028
Time frame: Approximately 6 months
PK: CL/F of IN10028
Time frame: Approximately 6 months
PK: Cmax,ss of IN10028
Time frame: Approximately 6 months
PK: Cmin,ss of IN10028
Time frame: Approximately 6 months
PK: Cav,ss of IN10028
Time frame: Approximately 6 months
PK: AUC0-tau of IN10028
Time frame: Approximately 6 months
PK: CLss/F of IN10028
Time frame: Approximately 6 months
PK: Vz,ss/F of IN10028
Time frame: Approximately 6 months
PK: Flu% of IN10028
Time frame: Approximately 6 months
PK: Rac of IN10028
Time frame: Approximately 6 months
To evaluate the rate of Objective Response Rate (ORR) of IN10028 in solid tumors.
Time frame: Approximately 1 year
To evaluate the time of Duration of Response (DoR) of IN10028 in solid tumors.
Time frame: Approximately 1 year
To evaluate the rate of Disease Control Rate (DCR) of IN10028 in solid tumors.
Time frame: Approximately 1 year
To evaluate the Time To Response (TTR) of IN10028 in solid tumors.
Time frame: Approximately 1 year
To evaluate the duration of Progression-free Survival (PFS) of IN10028 in solid tumors.
Time frame: Approximately 1 year
To Evaluate the duration of Overall survival (OS) of IN10028 in solid tumors.
Time frame: Approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jack zhang Clinical Trial Manager, bachelor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IN10028 in people with Advanced Solid Tumors, run by InxMed (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaofang liu Project Manager, Bachelor (86+13308303078, xiaofang.liu@inxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.