Actively Recruiting
Study to Evaluate Safety, Behavior, and Effects of HB0036 in Adults With Advanced Solid Tumors Including Non-Small Cell Lung Cancer
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
Researchers are evaluating HB0036 in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), in a Phase I/II, open-label, multicenter study. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of HB0036. Phase I focuses on safety and tolerability in patients with advanced solid tumors who have exhausted standard treatments. Phase II evaluates the safety and efficacy of HB0036 at a recommended dose in patients with NSCLC and other solid tumors, with a Safety Review Committee monitoring treatment safety throughout the study. Participants receive fixed doses of HB0036 administered intravenously every three weeks. Dose regimens are assigned in order of enrollment. Phase I involves dose escalation to find safe dosing, while Phase II includes cohorts with specific tumor types such as NSCLC and melanoma. Tumor samples are collected to confirm eligibility and PD-L1 expression for NSCLC patients. The study allows adjustments to dosing and frequency based on safety findings. Participants undergo various assessments including tumor imaging by CT or MRI to measure lesions, laboratory tests for organ function, and pregnancy tests for women of childbearing potential. Safety and tolerability are monitored for up to 12 months, and the maximum tolerated dose is assessed up to 24 months. Researchers also track adverse events and patient performance status. The total participation duration depends on treatment response and safety outcomes.
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
Complete this quick 3-step screening to check your eligibility
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
Y
Yang Zheng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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