Actively Recruiting
A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors
Led by HC Biopharma Inc. · Updated on 2026-03-17
331
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal cancer and determine the recommended dose for subsequent studies.
CONDITIONS
Official Title
A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the trial and voluntarily sign informed consent.
- Have locally recurrent or metastatic unresectable advanced solid tumors confirmed by pathology.
- Have at least one measurable lesion per RECIST v1.1 (excluding brain-only lesions).
- Eastern Cancer Assistance Group (ECOG) performance status of 0 or 1, stable for at least 2 weeks before first dose.
- Expected survival time greater than 3 months.
- Adequate organ and bone marrow function.
- Use effective contraception during treatment and for 6 months after last dose if of reproductive capacity.
You will not qualify if you...
- Tumor invading major blood vessels or poorly defined from vessels on imaging.
- Presence of brain metastasis, meningeal metastasis, or spinal cord compression.
- Prior use of anti-PD-1/PD-L1, anti-CTLA-4, or anti-VEGF targeted drugs.
- Anti-tumor therapy within 4 weeks before first study drug dose.
- Conditions affecting immune status such as active autoimmune disease, immunodeficiency, stem cell or organ transplantation (except corneal), recent live vaccine, or recent systemic corticosteroid/immunomodulatory use.
- Severe uncontrolled acute or chronic diseases including acute coronary syndrome, uncontrolled hypertension, poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding or coagulation disorders within 6 months.
- Other malignancies within 5 years prior to first dose.
- Major organ surgery within 4 weeks before first dose or significant trauma or planned elective surgery during trial.
- Unresolved adverse reactions from prior anti-tumor therapy worse than Grade 5.0.
- Known hypersensitivity to monoclonal antibodies or investigational drug components.
- Immune-related toxicity requiring permanent discontinuation from prior immunocheckpoint inhibitor therapy.
- Prior anti-angiogenic therapy with Grade 3 or higher toxicity.
- Investigator judgement that participation is unsuitable for other reasons.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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