A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors

Launched by HC BIOPHARMA INC. · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called HC010 for patients with advanced solid tumors, which are types of cancer that form in organs or tissues. The main goal of the study is to see how safe the treatment is and how well it works. It is currently looking for participants aged between 18 and 75 who have solid tumors that have not responded to standard treatments or do not have any available options left. To join the trial, participants need to have a confirmed diagnosis of their cancer, be able to provide a tissue sample for testing, and meet certain health criteria, such as having a good performance status and stable organ function.

If you decide to participate, you will receive HC010 as your only treatment, and the trial will monitor you closely for any side effects and how your cancer responds to the medication. This is a first-stage study, so while it may not offer a guaranteed cure, it could help researchers learn more about the treatment's potential benefits and risks for future patients. It’s important to know that there are specific health conditions and recent treatments that may exclude you from joining, so discussing your situation with your healthcare provider would be a good first step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF).
• • 2. Age ≥18 and ≤75, male or female.
• • 3. Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
• • 4. Participants must have at least one measurable lesion according to RECIST Version1.1
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
• • 6. Hepatocellular carcinoma patients with Child-Pugh score ≤ 7
• • 7. Expected survival time is at least 3 months
• • 8. Adequate organ function: neutrophil count≥1.5×109/L,platelet count ≥100×109/L,hemoglobin≥90g/L,alanine aminotransferase and aspartate aminotransferase ≤2.5×upper limit of normal (ULN); patients with hepatocellular carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN, renal function and cardiopulmonary function are basically normal.
• • 9. Subjects should provide, whenever possible, freshly obtained or archived tumor tissue sample prior to study treatment that can be used for biomarker analysis
• • 10. Participants of childbearing potential (males and females) must agree to effective contraception for at least 90 days from the time of signing the informed consent form to the time of the last dose; females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the HC010
• Exclusion Criteria:
• • 1. Receipt of any interventional clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of the HC010; Receipt of herbal or proprietary Chinese medicine with an anti-tumor indication within 2 weeks prior to the first dose of HC010;
• • 2. Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;
• • 3. Receipt of systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks prior to the first dose of HC010;
• • 4. Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;
• • 5. Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010;
• • 6. Patients who have received biomolecule therapy for anti-programmed death receptor 1 (PD-1)/programmed death ligand (PD-L1), anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) targets in prior antitumor therapy;
• • 7. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade≤1;
• • 8. History of immune-related adverse event (irAE) leading to permanent discontinuation from prior immunotherapy ,or grade ≥3 toxicity related to anti-angiogenic therapy from prior anti-angiogenic therapy；
• • 9. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation；
• • 10. Patients with known active brain metastases, or the presence of meningeal metastases, spinal cord compression, or molluscum contagiosum disease；
• • 11. Combination of other malignancies within 5 years prior to the first dose; excludes radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma and/or radically resected carcinoma in situ;
• • 12. Patients with active autoimmune disease, or a history of autoimmune disease；
• • 13. Infections: 1) active hepatitis B and C; Note: HBsAg and/or hepatitis B core antibody (HBcAb) positive individuals with HBV DNA ≥500 IU/ml (≥2000 IU/ml in patients with hepatocellular carcinoma) tested within 28 days prior to the initiation of treatment are eligible for inclusion.2) known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); 3) known active syphilis; 4) active tuberculosis; 5) active infection within two weeks prior to first dose of HC010;
• • 14. Unstable systemic disease, including but not limited to, severe cardiovascular disease; pleural effusion, pericardial effusion or peritoneal effusion requiring repeated drainage;
• • 15. Severe bleeding tendencies or coagulation disorders;
• • 16. History of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy;
• • 17. Females who are pregnant or breastfeeding;
• • 18. Inappropriate for this study in the opinion of the investigator;
• • 19. History of systemic hypersensitivity or anaphylaxis to any component of HC010.