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Study identifier: NCT06758557 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor

Condition: Advanced NSCLC · Advanced Endometrial Cancer  ·  Sponsor: Huabo Biopharm Co., Ltd.

PhasePhase 1/Phase 2
Planned participants282
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

This study is a multicenter, two-tumor, multi-cohort, dose-escalation and dose-expansion Phase Ib/II clinical trial of HB0025 combined with chemotherapy, consists of two phases: the dose escalation phase (Ib) and the dose expansion phase (II). 1. The dose escalation phase (Phase Ⅰb) The primary purpose is to determine the Maximum Tolerated Dose(MTD) and/or dose limiting toxicity (DLT) of HB0025 combined with chemotherapy. The dose escalation is carried out using the "3+3 dose escalation" principle. In the initial stage of the dose escalation process, the chemotherapy dose remains unchanged to explore the safety and tolerability of the currently confirmed safe doses of HB0025 as monotherapy at 10mg/kg, and 20mg/kg, combined with chemotherapy(Pemetrexed 500 mg/m² iv d1+Carboplatin AUC 5 iv d1) in the treatment of advanced non-squamous non-samll cell lung cancer(Non-sq-NSCLC), and combined with chemotherapy( Paclitaxel 175 mg/m² iv d1+ Carboplatin AUC 5 iv d1 ) in advance Endometrial carcinoma(EC). After completing the first cycle of treatment (DLT evaluation period), if the investigator determines that the subject may benefit from the combined treatment, the subject will continue the treatment cycles (2nd to 4th/5th/6th cycle of HB0025 combined with chemotherapy); if there is no disease progression and no intolerable toxicity, the subject can continue to receive the maintenance treatment with HB0025 + pemetrexed (for non-sq NSCLC) or HB0025 alone (for EC, sq NSCLC), until …

This description comes directly from the study's public registry record.

Talk to the study team

Caicun Zhou, PhD.  ·  +8613301825532  ·  caicunzhoudr@163.com

Always discuss trial participation with your own doctor first.

Locations (14)

Affiliated Hospital of Hebei University / School of Clinical MedicineBaoding, Hebei, ChinaRecruiting
Harbin Medical University Cancer HospitalHarbin, Heilongjiang, ChinaRecruiting
The First Affiliated Hospital of Henan University of Science & TechnologyLuoyang, Henan, ChinaRecruiting
Henan Cancer HospitalZhengzhou, Henan, ChinaRecruiting
The First People'S Hospital of LianyungãngLianyungang, Jiangsu, ChinaRecruiting
Liaoning Cancer Hospital&InstituteShenyang, Liaoning, ChinaRecruiting
Central Hospital Affiliated to Shandong First Medical UniversityJinan, Shandong, ChinaRecruiting
Linyi Cancer HospitalLinyi, Shandong, ChinaRecruiting
Weifang People'S HospitalWeifang, Shandong, ChinaRecruiting
Shanghai Pulmonary HospitalShanghai, Shanghai Municipality, ChinaRecruiting
Shanxi Cancer hospitalTaiyuan, Shanxi, ChinaRecruiting
The First Affiliated Hospitalof Xi'an Jiaotong UniversityXi’an, Shanxi, ChinaRecruiting

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06758557