Actively Recruiting
A Multicenter, Open Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HB0025 Injection Combined With Chemotherapy in Patients With Advanced Solid Tumor
Led by Huabo Biopharm Co., Ltd. · Updated on 2025-01-23
282
Participants Needed
14
Research Sites
17 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 studying the safety, tolerability, and preliminary effectiveness of a drug called HB0025 combined with chemotherapy in patients with advanced solid tumors, including non-squamous and squamous non-small cell lung cancer (NSCLC) and advanced endometrial cancer (EC). This multicenter Phase Ib/II clinical trial involves dose escalation to find the maximum safe dose and dose expansion to evaluate the drug's effects. The study aims to understand how well HB0025 works with chemotherapy in these patients, particularly those who have limited treatment options or have experienced disease progression after previous therapies. The trial has two main phases: Phase Ib focuses on dose escalation using a 3+3 method to determine the maximum tolerated dose and dose-limiting toxicities of HB0025 combined with fixed doses of chemotherapy drugs, including pemetrexed, carboplatin, and paclitaxel. After initial evaluation, patients may continue multiple cycles of combined treatment followed by maintenance therapy with HB0025 alone or combined with pemetrexed, depending on their cancer type. Phase II expands the study with multiple cohorts receiving specific doses of HB0025 combined with chemotherapy to further assess safety and preliminary efficacy, with approximately 40 subjects per cohort. Participants will undergo treatment cycles every three weeks, with evaluations including tumor assessments, laboratory tests, and monitoring for side effects. Researchers will measure outcomes such as objective response rate, disease control, overall survival, progression-free survival, and treatment-related adverse events over up to 24 months. Safety and response will be closely monitored throughout the trial, with treatment continuing until disease progression, unacceptable toxicity, withdrawal, or study completion. This study provides ongoing follow-up to evaluate the drug's impact and tolerability in advanced cancer patients.
CONDITIONS
Brief 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 aged 18 to 75 years
- Able to understand and voluntarily sign informed consent and comply with study procedures
- For dose escalation phase non-small cell lung cancer (NSCLC): confirmed NSCLC by histology or cytology, unsuitable for surgery, recurrent or metastatic, with specific EGFR or ALK mutations after progression or intolerance to targeted drugs, and no other oncogenic driver mutations with approved therapies
- For dose escalation phase endometrial cancer (EC): confirmed EC by histology or cytology with specified pathological types, unsuitable for surgery, recurrent or metastatic, no prior systemic anti-tumor treatment except adjuvant/neoadjuvant
- For dose expansion phase NSCLC: confirmed non-squamous or squamous NSCLC, unsuitable for surgery, recurrent or metastatic, negative for EGFR and ALK mutations, no other oncogenic driver mutations with approved therapies, no prior systemic anti-tumor treatment except certain adjuvant/neoadjuvant cases
- For dose expansion phase EC: confirmed EC with specified pathological types, unsuitable for surgery, recurrent or metastatic, no prior systemic anti-tumor treatment except certain adjuvant/neoadjuvant cases
- 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 score of 0 or 1
- Expected survival of at least 12 weeks
- Meet specified laboratory criteria for blood counts, liver and kidney function, coagulation, and urine protein
- Toxicity from prior treatment recovered to grade 1 or less
- Agree to effective contraception if of childbearing potential and have negative pregnancy test
You will not qualify if you...
- Brain metastasis with central nervous system symptoms unless stable after treatment
- Active or recent autoimmune diseases requiring systemic treatment within 2 years
- Use of systemic glucocorticoids or immunosuppressants above specified doses within 2 weeks before screening
- Active infection requiring long antibiotic treatment, active tuberculosis, HIV positive, active hepatitis B or C except stable carriers
- Prior immune checkpoint inhibitors combined with anti-vascular therapy
- History of severe allergies or immune-related adverse events to monoclonal antibodies or study drugs
- Uncontrolled high blood pressure despite treatment
- Serious comorbidities including recent thrombosis or bleeding disorders, significant cardiovascular or gastrointestinal diseases, unresolved fistulas, severe hydronephrosis, uncontrolled effusions, tumor invasion of major blood vessels, recent COPD exacerbation
- Use of anticoagulants or platelet aggregation inhibitors within 7 days before study treatment
- Recent major surgery, trauma, or invasive procedures within specified timeframes
- Past or current interstitial lung disease or severe lung impairment
- Pregnant or breastfeeding women
- History of organ or stem cell transplantation
- Second tumors within 5 years except some cured cancers
- Live virus vaccine within 30 days before screening
- Intolerance to specified chemotherapy regimens
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive HB0025 combined with chemotherapy drugs (Pemetrexed and Carboplatin or Paclitaxel and Carboplatin) administered intravenously every 3 weeks.
Treatment visits every 3 weeks with chemotherapy on Day 1 of each cycle
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
Actively Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here