BridgeMD
Tests treatment safety and results for Advanced Solid Tumor
Official title A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06307925
What this study is testing
What is HC010?
HC010 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form...
- Age ≥18 and ≤75, male or female.
- Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no...
- Participants must have at least one measurable lesion according to RECIST Version1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
You likely can't join if
- Receipt of any treatment clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is...
- Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;
- Receipt of systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks...
- Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;
- Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010;
- Patients who have received biomolecule therapy for anti-programmed death receptor 1 (PD-1)/programmed death ligand (PD-L1), anti-cytotoxic...
See the full eligibility criteria
- Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF).
- Age ≥18 and ≤75, male or female.
- Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
- Participants must have at least one measurable lesion according to RECIST Version1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Hepatocellular carcinoma patients with Child-Pugh score ≤ 7
- Expected survival time is at least 3 months
- 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...
- people should provide, whenever possible, freshly obtained or archived tumor tissue sample prior to study treatment that can be used for biomarker analysis
- 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...
- Receipt of any treatment 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...
- Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;
- 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;
- Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;
- Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010;
- 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...
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade≤1;
- 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；
- Previous allogeneic hematopoietic stem cell transplantation or organ transplantation；
- Patients with known active brain metastases, or the presence of meningeal metastases, spinal cord compression, or molluscum contagiosum disease；
- 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...
- Patients with active autoimmune disease, or a history of autoimmune disease；
- 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...
- Unstable systemic disease, including but not limited to, severe cardiovascular disease; pleural effusion, pericardial effusion or peritoneal effusion requiring repeated drainage;
- Severe bleeding tendencies or coagulation disorders;
- History of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy;
- Females who are pregnant or breastfeeding;
- Inappropriate for this study in the opinion of the investigator;
- History of systemic hypersensitivity or anaphylaxis to any component of HC010.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.