Advanced Solid TumorsPhase 1NCT07229898
A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors
A Phase 1 study testing GEN-725 tablets in people with Advanced Solid Tumors, run by Henan Genuine Biotech Co., Ltd. at 4 sites in China.
Trial summary
A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets 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?
- GEN-725 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesChina
- Study dates
- 7 Jan 2025to 31 Dec 2026
- 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
- Understand and voluntarily sign the informed consent form (ICF).
- Aged ≥ 18 years and ≤ 75 years, regardless of gender.
- Subjects must meet the following criteria:
- Diagnosed by histology or cytology with advanced solid tumors that have progressed after standard treatment, are intolerant to standard treatment, have no standard treatment available, or are judged by the investigator as unsuitable for standard treatment. Tumor types include but are not limited to: NSCLC, HCC, CRC, bladder cancer, breast cancer, etc.; AND b) Time since prior anti-PD-1/PD-L1 monoclonal antibody monotherapy or combination therapy to recurrence/progression is ≥ 6 months.
- Presence of at least one measurable lesion (RECIST v1.1 criteria).
- ECOG performance status score of 0 or 1.
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- For HCC patients, must have Child-Pugh class A or B, without hepatic encephalopathy.
- Expected survival time ≥ 3 months.
- Toxicities from prior treatments (except for alopecia and pigmentation) have all recovered to Grade 1 or normal levels.
- Adequate organ function, meeting all of the following laboratory test results prior to enrollment:
- Hematology: ANC ≥ 1.5×10^9/L, platelet count ≥ 75×10^9/L, hemoglobin ≥ 90 g/L;
- Liver function: Serum bilirubin ≤ 1.5×upper limit of normal (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5×ULN, or if liver metastases are present, AST and ALT ≤ 5×ULN;
- Renal function: Serum creatinine (Cr) ≤ 1.5×ULN, Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min;
- Coagulation function: International normalized ratio (INR) ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.
- Subjects with reproductive potential (including spouses of male subjects) have no plan for pregnancy or sperm donation from screening until 6 months after the last dose, and are willing to use at least one effective contraception method.
Who cannot join
- Subjects with a history of allergic reactions to GEN-725 tablets or to active or inactive excipients of drugs with similar chemical structures or of the same class.
- Subjects who meet any of the following criteria:
- Have received systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug;
- Have received hormonal anti-tumor therapy, small molecule targeted therapy, oral fluorouracil drugs, or endocrine therapy within 2 weeks prior to the first dose of the investigational drug;
- Have undergone palliative local therapy for non-target lesions within 2 weeks prior to the first dose of the investigational drug;
- Have received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 4 weeks prior to the first dose of the investigational drug;
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- Have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.
- Subjects who have received anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug, or who plan to receive such vaccines during the study period.
- Subjects who have received systemic therapy with corticosteroids (> 10 mg/day of dexamethasone or equivalent dose) or other immunosuppressive drugs within 4 weeks prior to the first dose of the investigational drug. However, topical applications (e.g., ointments, eye drops, inhalants, or nasal sprays) are permitted, provided the dosage does not exceed the recommended dose in the prescribing information and there are no signs of systemic exposure.
- Subjects with a history of acute or chronic pancreatitis.
- Subjects with brain metastases and/or carcinomatous meningitis (except for those with brain metastases that have been adequately treated, have remained stable for at least 3 months prior to screening, have all neurological symptoms returned to baseline levels, show no evidence of new or enlarging metastases, and have ceased radiotherapy, surgery, or steroid therapy for at least 4 weeks prior to the first dose of the investigational drug).
- Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
- Subjects with a history or evidence of significant cardiovascular disease within 6 months prior to screening, including but not limited to:
- History of myocardial infarction, coronary angioplasty or bypass grafting, valvular heart disease or valvular repair, clinically significant arrhythmias requiring treatment, unstable angina, transient ischemic attack, cerebrovascular accident, etc.;
- Congestive heart failure classified as Class III or IV according to the New York Heart Association (NYHA) criteria.
- Subjects with clinically significant abnormalities in the 12-ECG examination during screening, including but not limited to severe arrhythmias, prolonged QT interval (QTcF: > 450 ms for males, > 470 ms for females; QTc interval calculated using Fridericia's formula); or the presence of any condition that may increase the risk of QT prolongation, such as a known history of QTc prolongation, congenital long QT syndrome, Brugada syndrome, torsades de pointes, uncontrolled electrolyte disturbances (e.g., hypocalcemia, hypokalemia, hypomagnesemia, etc.).
- Subjects with hypertension uncontrolled by antihypertensive medication (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg).
- Subjects with presence of persistent or active infection that remains poorly controlled despite medication, including but not limited to:
- Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quantification ≥ the upper limit of normal (ULN);
- Hepatitis C virus antibody (HCV-Ab) positive and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ ULN;
- Note: HBV-DNA testing is required only for HBsAg positive subjects; HCV-RNA testing is required only for HCV-Ab positive subjects.
- Subjects with existing autoimmune diseases or related symptoms, or a history of autoimmune diseases, immunodeficiency diseases (e.g., leukemia, HIV, etc.), or a history of organ transplantation.
- Subjects with active, uncontrolled systemic infection (e.g., bacterial, viral, or fungal) despite optimal therapy.
- Subjects with a history of or current interstitial lung disease, pulmonary fibrosis, drug-induced interstitial pneumonia, or radiation pneumonitis requiring steroid treatment.
- Subjects with moderate to large pleural effusion, pericardial effusion, or ascites requiring pharmacological or medical intervention.
- Subjects who have had other malignancies ( except radically cured basal cell carcinoma of the skin, squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, etc.) within 5 years prior to the first dose of the investigational drug, except for the tumor being treated in this study.
- Subjects who have undergone major surgery within 3 months prior to screening and have not fully recovered, or who plan to undergo major surgery during participation in this study (except for outpatient surgeries judged by the investigator to have no impact on subject safety or trial outcomes).
- Subjects with uncontrollable nausea, vomiting, inability to swallow normally, or those with chronic gastrointestinal diseases, gastrointestinal obstruction, or other conditions that may affect the administration and absorption of the investigational drug.
- Subjects with a documented history of psychiatric disorders, or a history of psychotropic drug abuse, drug abuse, or alcohol abuse.
- Women who are pregnant or breastfeeding.
- Subjects who have participated in any other drug clinical trial or are receiving other investigational therapies within 4 weeks prior to the first dose of the investigational drug (or within 5 half-lives of another investigational drug, whichever is longer) (except for patients participating only in the overall survival follow-up phase of a study).
- Any other condition deemed by the investigator as inappropriate for participation in this clinical trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
- Recruiting
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan
- Recruiting
Shanghai East Hospital
Shanghai
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
About this study
Official title: A Phase Ⅰ Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GEN-725 Tablets in Patients With Advanced Solid Tumors
A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- GEN-725 tablets
- Keywords
- Advanced Solid Tumors, GEN-725
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN-725 tabletsDrug
Dose-escalation part: Subjects received GEN-725 tablets at doses of 4, 6 and 8 mg. A single oral dose was administered on Cycle 1 Day 1, observation was conducted for 4 days (i.e., after oral administration of 1 GEN-725 tablet followed by a 4-day washout period), then once daily from Day 5 onward. Dosing occurred with 21 days of continuous treatment per cycle (from Day 5 to Day 25).
Dose-expansion part: Subjects received GEN-725 tablets orally at a dose that depends on the outcome of dose-escalation, administered once daily for 21 consecutive days per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Dose-escalation part and dose-expansion part Receives: Drug: GEN-725 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Dose-Limiting Toxicity (DLT) (Dose-escalation part)
Measured: Day 25
Incidence and severity of adverse events (AEs) (Dose-escalation part)
AEs are assessed based on NCI CTCAE v5.0.
Measured: From the signing of the Informed Consent Form (ICF) by the subjects until 28±7 days after the last administration of the study drug.
Overall Response Rate (ORR) (Dose-expansion part)
Measured: Up to approximately 24 months.
Secondary outcomes (11)
Maximum Plasma Concentration (Cmax) of GEN-725 (Dose-escalation part and dose-expansion part)
Measured: Up to 72 hours post-dose in dose-escalation part and 24 hours post-dose in dose-expansion part.
Time to Maximum Plasma Concentration (Tmax) of GEN-725 (Dose-escalation part and dose-expansion part)
Measured: Up to 72 hours post-dose in dose-escalation part and 24 hours post-dose in dose-expansion part.
Steady-State Valley Concentration (Css,min) of GEN-725 (Dose-escalation part and dose-expansion part)
Measured: Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.
Steady-State Peak Concentration (Css,max) of GEN-725 (Dose-escalation part and dose-expansion part)
Measured: Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.
Overall Response Rate (ORR) (Dose-escalation part)
Measured: Up to approximately 24 months.
Disease Control Rate (DCR) (Dose-escalation part and dose-expansion part)
Measured: Up to approximately 24 months.
Duration of Response (DOR) (Dose-escalation part and dose-expansion part)
Measured: Up to approximately 24 months.
Progression-Free Survival (PFS) (Dose-escalation part and dose-expansion part)
Measured: Up to approximately 24 months.
Overall Survival (OS) (Dose-escalation part and dose-expansion part)
Measured: Up to approximately 24 months.
Evaluation of life quality per EORTC QLQ-C30 score changes (Dose-escalation part and dose-expansion part)
Measured: Up to approximately 24 months.
Incidence and severity of adverse events (AEs) (Dose-expansion part)
AEs are assessed based on NCI CTCAE v5.0.
Measured: From the signing of the Informed Consent Form (ICF) by the subjects until 28±7 days after the last administration of the study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start7 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229898
- Sponsor's protocol ID
- GEN-725-R001
- Status last verified
- Oct 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GEN-725 Tablets in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07229898
- Acronym / sponsor ID
- GEN-725-R001
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, GEN-725
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 2025 (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.
A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: GEN-725 tabletsDose-escalation part and dose-expansion part |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Understand and voluntarily sign the informed consent form (ICF).
- Aged ≥ 18 years and ≤ 75 years, regardless of gender.
- Subjects must meet the following criteria:
- Presence of at least one measurable lesion (RECIST v1.1 criteria).
- ECOG performance status score of 0 or 1.
Key exclusion criteria (32 listed)
- Subjects with a history of allergic reactions to GEN-725 tablets or to active or inactive excipients of drugs with similar chemical structures or of the same class.
- Subjects who meet any of the following criteria:
- Have received systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the investigational drug;
- Have received hormonal anti-tumor therapy, small molecule targeted therapy, oral fluorouracil drugs, or endocrine therapy within 2 weeks prior to the first dose of the investigational drug;
- Have undergone palliative local therapy for non-target lesions within 2 weeks prior to the first dose of the investigational drug;
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 |
|---|---|---|
| GEN-725 tabletsDose-escalation part: Subjects received GEN-725 tablets at doses of 4, 6 and 8 mg. A single oral dose was administered on Cycle 1 Day 1, observation was conducted for 4 days (i.e., after oral administration of 1 GEN-725 tablet followed by a 4-day washout period), then once daily from Day 5 onward. Dosing occurred with 21 days of continuous treatment per cycle (from Day 5 to Day 25). Dose-expansion part: Subjects received GEN-725 tablets orally at a dose that depends on the outcome of dose-escalation, administered once daily for 21 consecutive days per cycle. | Drug | Experimental |
Primary outcome
Number of patients with Dose-Limiting Toxicity (DLT) (Dose-escalation part)
Time frame: Day 25
Incidence and severity of adverse events (AEs) (Dose-escalation part)
Time frame: From the signing of the Informed Consent Form (ICF) by the subjects until 28±7 days after the last administration of the study drug.
AEs are assessed based on NCI CTCAE v5.0.
Overall Response Rate (ORR) (Dose-expansion part)
Time frame: Up to approximately 24 months.
11 secondary outcomes
Maximum Plasma Concentration (Cmax) of GEN-725 (Dose-escalation part and dose-expansion part)
Time frame: Up to 72 hours post-dose in dose-escalation part and 24 hours post-dose in dose-expansion part.
Time to Maximum Plasma Concentration (Tmax) of GEN-725 (Dose-escalation part and dose-expansion part)
Time frame: Up to 72 hours post-dose in dose-escalation part and 24 hours post-dose in dose-expansion part.
Steady-State Valley Concentration (Css,min) of GEN-725 (Dose-escalation part and dose-expansion part)
Time frame: Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.
Steady-State Peak Concentration (Css,max) of GEN-725 (Dose-escalation part and dose-expansion part)
Time frame: Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.
Overall Response Rate (ORR) (Dose-escalation part)
Time frame: Up to approximately 24 months.
Disease Control Rate (DCR) (Dose-escalation part and dose-expansion part)
Time frame: Up to approximately 24 months.
Duration of Response (DOR) (Dose-escalation part and dose-expansion part)
Time frame: Up to approximately 24 months.
Progression-Free Survival (PFS) (Dose-escalation part and dose-expansion part)
Time frame: Up to approximately 24 months.
Overall Survival (OS) (Dose-escalation part and dose-expansion part)
Time frame: Up to approximately 24 months.
Evaluation of life quality per EORTC QLQ-C30 score changes (Dose-escalation part and dose-expansion part)
Time frame: Up to approximately 24 months.
Incidence and severity of adverse events (AEs) (Dose-expansion part)
Time frame: From the signing of the Informed Consent Form (ICF) by the subjects until 28±7 days after the last administration of the study drug.
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 17 Nov 2025.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEN-725 tablets in people with Advanced Solid Tumors, run by Henan Genuine Biotech Co., Ltd. at 4 sites 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 16 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Caicun Zhou (021-38804518, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Dose-Limiting Toxicity (DLT) (Dose-escalation part) (time frame: Day 25). The study lists 3 primary outcomes in all. 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 17 Nov 2025.