Actively Recruiting
Study of HB0025 Injection Combined With Chemotherapy for Safety and Preliminary Effectiveness in Advanced Solid Tumors A Multicenter Phase Ib/II Trial in Non-Small Cell Lung and Endometrial Cancer
Led by Huabo Biopharm Co., Ltd. · Updated on 2025-01-23
282
Participants Needed
14
Research Sites
108 weeks
Total Duration
On this page
Sponsors
H
Huabo Biopharm Co., Ltd.
Lead Sponsor
S
Shanghai Huaota Biopharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter Phase Ib/II study to evaluate the safety, tolerability, and preliminary effectiveness of HB0025 combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) and advanced endometrial cancer (EC). The trial includes two phases: a dose escalation phase to determine the maximum tolerated dose and dose-limiting toxicities, and a dose expansion phase to assess the efficacy and safety of selected doses in larger patient groups. In the dose escalation phase, HB0025 is given intravenously every 3 weeks at varying doses (6 to 30 mg/kg) combined with fixed chemotherapy regimens depending on the cancer type. For non-squamous NSCLC, HB0025 is combined with pemetrexed and carboplatin; for squamous NSCLC and endometrial cancer, it is combined with paclitaxel and carboplatin. After initial cycles, patients may continue maintenance treatment with HB0025 plus pemetrexed or HB0025 alone until intolerable toxicity, disease progression, or other study endpoints occur. The dose expansion phase enrolls about 40 patients per cohort at selected doses to further evaluate treatment safety and preliminary response. Participants will undergo multiple treatment cycles with scheduled assessments including tumor measurements by RECIST 1.1 criteria, safety monitoring, laboratory tests, and evaluation of response over up to 24 months. The primary outcome measured is the objective response rate. Patients are monitored closely for adverse effects throughout treatment and maintenance until disease progression, withdrawal, or study completion. This study aims to better understand the potential of HB0025 combined with chemotherapy in treating these advanced cancers.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 75 years old
- Able to understand and voluntarily sign informed consent and comply with study procedures
- For dose escalation phase: NSCLC confirmed by histology or cytology, not suitable for surgery, recurrent/metastatic/locally advanced, with specific mutation and treatment history criteria
- For dose escalation phase: Endometrial cancer confirmed by histology or cytology, not suitable for surgery, recurrent/metastatic/locally advanced, no prior systemic anti-tumor treatment
- For dose expansion phase: NSCLC (non-squamous or squamous) confirmed by histology or cytology, not suitable for surgery, recurrent/metastatic/locally advanced, negative for specific mutations, no prior systemic anti-tumor treatment with exceptions
- For dose expansion phase: Endometrial cancer confirmed by histology or cytology, not suitable for surgery, recurrent/metastatic/locally advanced, no prior systemic anti-tumor treatment with exceptions
- No anti-tumor treatment or clinical trial drugs within 4 weeks before first HB0025 dose
- At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status 0 or 1
- Expected survival of at least 12 weeks
- Specific laboratory test criteria for blood counts, kidney, liver function, coagulation, and urine protein
- Toxicity from previous treatments recovered to grade 1 except certain exceptions
- Women and men of childbearing potential agree to effective contraception during and 3 months post-study; females must have negative pregnancy test
You will not qualify if you...
- Brain metastasis with central nervous system symptoms unless stable and treated as defined
- Active autoimmune diseases or history requiring systemic treatment within 2 years, with some exceptions
- Use of systemic glucocorticoids or immunosuppressants within 2 weeks before screening, with some topical treatment exceptions
- Active infections including recent infections requiring antibiotics, active pulmonary tuberculosis, HIV positive, active hepatitis B or C, with some exceptions
- Prior treatment with immune checkpoint inhibitors combined with anti-vascular therapy
- History of severe allergies or serious immune-related adverse events, or known allergies to study drugs or components
- Uncontrolled high blood pressure despite treatment
- Serious comorbidities including recent thrombosis, bleeding disorders, significant cardiovascular or cerebrovascular diseases, gastrointestinal conditions causing bleeding or perforation, unhealed fistulas or abscesses, hydronephrosis, poorly controlled effusions, tumor invasion of important vessels, acute COPD exacerbation
- Use of anticoagulants or platelet aggregation inhibitors within 7 days before treatment
- Recent major surgery, biopsy, or trauma within specified timeframes
- Past or current lung diseases that interfere with pulmonary toxicity assessment
- Pregnant or breastfeeding women
- History of organ or stem cell transplantation
- Second tumor within 5 years except certain cured cancers
- Receipt of live virus vaccine within 30 days before screening
- Intolerance to specific chemotherapy regimens during screening
- Investigator assessment of unsuitability for trial participation
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Affiliated Hospital of Hebei University / School of Clinical Medicine
Baoding, Hebei, China, 0312
Actively Recruiting
2
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 0451
Actively Recruiting
3
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 0379
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 0371
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5
The First People'S Hospital of Lianyungãng
Lianyungang, Jiangsu, China, 0518
Actively Recruiting
6
Liaoning Cancer Hospital＆Institute
Shenyang, Liaoning, China, 024
Actively Recruiting
7
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 0531
Actively Recruiting
8
Linyi Cancer Hospital
Linyi, Shandong, China, 0539
Actively Recruiting
9
Weifang People'S Hospital
Weifang, Shandong, China, 0536
Actively Recruiting
10
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 021
Actively Recruiting
11
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 0351
Actively Recruiting
12
The First Affiliated Hospitalof Xi'an Jiaotong University
Xi’an, Shanxi, China, 029
Actively Recruiting
13
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 0871
Actively Recruiting
14
The First Affiliated Hospitalzhejiang University School of Medicine
Hangzhou, Zhejiang, China, 0571
Actively Recruiting
Research Team
C
Caicun Zhou, PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Frequently Asked Questions
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