Actively Recruiting
A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
Led by Shanghai Huaota Biopharmaceutical Co., Ltd. · Updated on 2025-01-03
80
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is a Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- For Phase I: Histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors or clinically diagnosed hepatocellular carcinoma that failed all standard therapies
- For Phase II: Histologically or cytologically documented locally advanced, recurrent, or metastatic cancer, including NSCLC and other solid tumors
- Availability of tumor specimens for NSCLC patients and tumor PD-L1 expression with TPS ≥1%
- Negative for actionable molecular markers such as EGFR and ALK mutations
- At least one measurable lesion as per RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function within 14 days of first dose
- Negative pregnancy test for women of childbearing potential within 3 days prior to treatment
- Agreement to use effective contraception during and for 90 days after study treatment
- Recovery to Grade 0-1 from prior anticancer therapy adverse events except for certain mild conditions
- Ability to understand and sign informed consent and comply with study procedures
You will not qualify if you...
- Concurrent malignancy within 5 years except certain treated cancers
- Prior treatments targeting TIGIT pathway (Phase I) or prior simultaneous PD-1 and TIGIT inhibitor therapy (Phase II)
- Antibiotic treatment lasting over 1 week within 28 days before first dose
- Active central nervous system metastases or carcinomatous meningitis unless stable and asymptomatic
- History of interstitial lung disease or non-infectious pneumonitis except from radiotherapy
- Active autoimmune disease or history requiring systemic therapy within 2 years except specific conditions
- History of severe immune-related adverse events or discontinuation due to such events
- Use of systemic corticosteroids above 10 mg/day prednisone or immunosuppressive agents within 2 weeks prior to screening
- Recent anticancer therapy, radiation, or major surgery within specified time frames
- Recent cardiovascular events or uncontrolled arrhythmias
- Prior allogeneic stem cell or solid organ transplantation
- Recent live vaccine except COVID-19 vaccine
- Significant clinical or laboratory abnormalities affecting study evaluation
- Positive HIV test
- Active hepatitis B or C infection except controlled cases
- Positive COVID-19 test during screening unless negative after quarantine
- Active tuberculosis under treatment or recent treatment within 1 year
- Pregnancy, lactation, or refusal to use contraception
- History of severe allergic reactions to monoclonal antibodies or components of HB0036
- Participation in another clinical trial within 4 weeks prior to first dose
- Substance abuse within 2 years
- Other serious medical or psychiatric conditions or investigator judgment against participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Horizon Oncology
Lafayette, Indiana, United States, 47905
Actively Recruiting
2
Next Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
3
Summit Cancer Centers
Spokane, Washington, United States, 99216
Actively Recruiting
4
Shandong Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
Research Team
J
Jingjing Wang, Master
CONTACT
Y
Yang Zheng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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