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

A Phase I Open-label, Multi-center, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: HC010

Detailed Description

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.Enrollment is for patients with advanced adult solid tumors (including but not limited to non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer, triple-negative breast cancer, gastric cancer/gastroesophageal junction adenocarcinoma, ovarian cancer, pancreatic cancer, bladder cancer, and renal cancer) who have either failed to respond to standard of care or who are unable to receive/do not have access to standard of care.Subjects received HC010 monotherapy by intravenous infusion every two weeks in 1 cycle of 28 days, and were treated until completion of 2 years of study treatment, disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or fulfillment of other criteria for termination of treatment, whichever occurred first. The primary study endpoints were safety and tolerability, maximum tolerated dose (MTD) and/or recommended dose for phase II clinical studies (RP2D); secondary endpoint indicators included pharmacokinetic indicators, efficacy indicators [objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)], immunogenicity indicators such as anti-drug antibody (ADA) and neutralizing antibody (Nab). Exploratory endpoints included the pharmacokinetic (PD) index of HC010, the relationship between peripheral blood T-cell receptor occupancy (RO) and safety and efficacy, as well as the correlation between PD-L1 expression level in tumor tissues and efficacy.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Langxi Zhang, Ph.D; Phone Number: +86 21 5043 3368; Email: langxi.zhang@btyy.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Li Zhang, MD; Phone Number: +86 139 0228 2893; Email: zhangli@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose-escalation phase; HC010 0.15mg/kg to 20mg/kg Q2w/28d intravenous infusion	Drug: HC010; HC010 Q2W/28d intravenous infusion
Experimental: dose expansion phase; Fixed dose of HC010 Q2w/28d intravenous infusion	Drug: HC010; HC010 Q2W/28d intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events	2 years
Incidence of dose-limiting toxicity	Incidence of dose-limiting toxicity	28 days
serious adverse events	serious adverse events	2 years
Maximum Tolerated Dose	Maximum Tolerated Dose	2 years
Recommended Dose for Phase II Clinical Studies	Recommended Dose for Phase II Clinical Studies	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival	2 years
progression-free survival	progression-free survival	2 years
pharmacokinetics:Cmax	pharmacokinetics:Cmax	2 years
Objective response rate	Objective response rate (ORR)	2 years
duration of response	duration of response (DoR)	2 years
Disease control rate	Disease control rate	2 years
pharmacokinetics:AUC0-last	pharmacokinetics:AUC0-last	2 years
pharmacokinetics:tmax	pharmacokinetics:tmax	2 years
pharmacokinetics:Vd	pharmacokinetics:Vd	2 years

Collaborators and Investigators

• Sponsor: HC Biopharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; Non-small cell lung cancer; Hepatocellular carcinoma; advanced solid tumor; cervical cancer
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HC010-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No