Actively Recruiting
A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer
Led by HC Biopharma Inc. · Updated on 2026-02-02
328
Participants Needed
1
Research Sites
61 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 lung cancer and determine the recommended dose for subsequent studies.
CONDITIONS
Official Title
A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand this trial and voluntarily sign the informed consent form.
- Have locally recurrent or metastatic non-resectable advanced solid tumors diagnosed by pathology and not treatable by radiotherapy.
- For dose expansion: diagnosed with NSCLC without standard care or NSCLC with EGFR-sensitive mutations progressing after EGFR-TKI therapy.
- First-line patients with driver gene negative NSCLC or extensive small cell lung cancer.
- Have at least one measurable lesion according to RECIST v1.1 (excluding only brain lesions).
- Have an ECOG performance score of 0 or 1, stable for 2 weeks before first dose.
- Expected survival time longer than 3 months.
- Adequate organ and bone marrow function.
- Females of childbearing potential must have a negative pregnancy test within 7 days before first dose and not be breastfeeding.
- Agree to use reliable contraception for at least 6 months from consent until after last dose if of childbearing potential.
- Women not of childbearing potential (postmenopausal for at least 1 year or surgically sterilized) are exempt from pregnancy test and contraception requirements.
You will not qualify if you...
- Tumor invades major blood vessels or is not clearly separated from blood vessels on imaging.
- Combination of brain metastasis, meningeal metastasis, and spinal cord compression.
- Prior use of PD-1/PD-L1, CTLA-4, or VEGF targeted drugs.
- Anti-tumor treatments including radiotherapy, biological, endocrine, targeted or immunotherapy within 4 weeks before first dose.
- Conditions affecting immune status such as active autoimmune disease, immunodeficiency, stem cell or organ transplantation (except corneal transplant), recent live vaccine, or recent systemic corticosteroid or immunomodulatory drug use.
- Severe uncontrolled acute or chronic diseases like acute coronary syndrome, uncontrolled hypertension, poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding or coagulation disorders within past 6 months.
- Other cancers within 5 years before first dose.
- Major organ surgery (except biopsy) within 4 weeks before first dose, significant trauma, or planned elective surgery during trial.
- Unresolved adverse reactions from prior anti-tumor treatment worse than grade 5.
- Known allergies to monoclonal antibodies or any components of investigational drug.
- Known or suspected immune-related toxicity leading to permanent discontinuation after prior immunocheckpoint inhibitor therapy.
- Prior anti-angiogenic therapy with grade 3 or higher toxicity.
- Investigator considers participant unsuitable for the trial for other reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Q
QiQi huang Huang, master
CONTACT
L
Li Zhang, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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