A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors

NCT07229898 | Recruiting Phase 1 DMC

• 1 other identifier: GEN-725-R001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors; GEN-725

Outcome Measures

Primary Outcomes (3)

• Number of patients with Dose-Limiting Toxicity (DLT) (Dose-escalation part)

  Day 25

• Incidence and severity of adverse events (AEs) (Dose-escalation part)

  AEs are assessed based on NCI CTCAE v5.0.

  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)

  Up to approximately 24 months.

Secondary Outcomes (11)

• Maximum Plasma Concentration (Cmax) of GEN-725 (Dose-escalation part and dose-expansion part)

  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)

  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)

  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)

  Up to Day 26 in dose-escalation part and Day 22 in dose-expansion part.

• Overall Response Rate (ORR) (Dose-escalation part)

  Up to approximately 24 months.

Study Arms (1)

Experimental

EXPERIMENTAL

Dose-escalation part and dose-expansion part

Drug: GEN-725 tablets

Interventions

GEN-725 tablets DRUG

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.

Experimental

Eligibility Criteria

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

You may qualify if:

• Understand and voluntarily sign the informed consent form (ICF).
• Aged ≥ 18 years and ≤ 75 years, regardless of gender.
• Subjects must meet the following criteria:
• a) 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.
• 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%.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Henan Genuine Biotech Co., Ltd.: lead

Study Sites (4)

Harbin Medical University Cancer Hospital

Harbin, China

RECRUITING

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, China

RECRUITING

Shanghai East Hospital

Shanghai, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

RECRUITING

Central Study Contacts

Caicun Zhou

CONTACT

021-38804518; caicunzhoudr@163.com

Study Design

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

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (4)