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A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib

A Phase Ⅰ/Ⅱa Clinical Study Evaluating the Efficacy and Safety of GEN-725 in Combination With Dositinib in Patients With Locally Advanced or Metastatic EGFR-Mutant Non-small Cell Lung Cancer

NCT07362940•Henan Genuine Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label phase I/phase II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GEN-725 in combination with Dositinib in participants with locally advanced or metastatic EGFR-mutant non-small cell lung cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18-75 years old (including 18 and 75 years old), male or female.
•2. Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not amenable to curative surgery or radiotherapy. (For subjects naive to EGFR-TKI therapy, paraffin-embedded tissue blocks, unstained slides, or fresh tumor tissue samples must be available for EGFR testing.)
•3. Patients with a positive EGFR mutation. (For patients with prior third-generation EGFR-TKI therapy, post-progression EGFR mutation test results are recommended.)
•4. a) Phase Ⅰ Dose Escalation Stage: EGFR-mutant NSCLC patients who have received at least one prior line of therapy (chemotherapy or targeted therapy are allowed). Patients who have received prior neoadjuvant, adjuvant, and/or radical concurrent/sequential chemoradiotherapy (including chemotherapy, immunotherapy, targeted therapy, etc.) must have documented disease recurrence or progression within \<6 months of completing the last regimen. b) Phase Ⅱa Dose Expansion Stage: Cohort 1: NSCLC patients with disease progression on a prior third-generation EGFR-TKI. Cohort 2: EGFR mutant NSCLC patients who are EGFR-TKI-naive.
•5. Patients with at least one measurable or evaluable lesion per RECIST 1.1 criteria.
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a life expectancy of at least 12 weeks.
•7. Adequate organ function must meet the following criteria (with no transfusion of blood, blood products, no administration of hematopoietic growth factors, or no infusion of albumin/blood products within 14 days before laboratory testing):
•1. Absolute neutrophil (NE) count ≥ 1.5 × 10\^9/L.
•2. Platelet (PLT) count ≥ 100 × 10\^9/L.
•3. Hemoglobin (HGB) ≥ 100 g/L.
+12 more criteria

Exclusion Criteria

•1. Patients have previously received any of the following treatments:
•1. Undergone major surgery within 4 weeks prior to the first administration;
•2. Antitumor therapy including chemotherapy, immunotherapy, targeted therapy, etc., within 4 weeks prior to the first administration; for oral small-molecule targeted drugs, within 2 weeks or within 5 half-lives prior to the first administration (whichever is shorter);
•3. Radiation therapy involving \>30% of the bone marrow or large-field radiation therapy within 4 weeks prior to the first administration;
•4. Strong inhibitors or inducers of CYP3A4 within 7 days prior to the first administration;
•5. Traditional Chinese medicine (TCM) or TCM preparations that have antitumor indications, or that are intended for tumor adjuvant therapy within 14 days prior to the first administration;
•2. Presence of unresolved toxicities from previous anticancer therapy, with Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade \>1 (except alopecia) at the start of study treatment. The pre-existing neuropathy from previous platinum-therapy is allowed up to grade 2;
•3. Patients with meaningful bypass mutations of corresponding marketed drugs, including but not limited to: MET exon 14 skipping mutation, MET amplification, ALK fusion, HER-2 mutation, ROS-1 fusion, RET fusion, BRAF V600E mutation, KRAS G12C, NTRK fusion, etc. (Applicable only to the dose expansion period, and will be adjusted according to the gene detection results from the dose escalation period);
•4. Patients with disease progression (PD) or stable disease (SD) with a duration of ≤3 months following treatment with a third-generation EGFR-TKI;
•5. Patients with any uncontrolled systemic disease, as determined by the investigator, such as uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg after optimal medical therapy), uncontrolled diabetes, coronary artery stenosis, aortic dissection, aortic aneurysm, active bleeding diathesis, etc.;
+12 more criteria

Locations (5)

Beijing Cancer Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital, Shandong cancer prevention and treatment institute)

Jinan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

Henan Cancer Hospital

Zhengzhou, China

Key Dates

Start Date

November 27, 2025

Primary Completion Date

July 31, 2027

Completion Date

December 31, 2028

Last Updated

January 23, 2026

Enrollment

110

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

GEN-725 tablets + Dositinib mesylate tablets

DRUG

Contacts

Jun Zhou

CONTACT

010-88196456 ohjerry@163.com

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Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase Ⅰ/Ⅱa Clinical Study of GEN-725 in Combination With Dositinib

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)