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

NCT06307925 | Recruiting Phase 1 DMC

• 1 other identifier: HC010-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumor

Keywords

advanced solid tumor; Non-small cell lung cancer; Hepatocellular carcinoma; colorectal cancer; cervical cancer

Outcome Measures

Primary Outcomes (5)

• Incidence of dose-limiting toxicity

  Incidence of dose-limiting toxicity

  28 days

• Adverse events

  Adverse events

  2 years

• 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 Outcomes (9)

• pharmacokinetics:Cmax

  2 years

• Objective response rate

  2 years

• duration of response

  2 years

• progression-free survival

  2 years

• overall survival

  2 years

Study Arms (2)

dose-escalation phase

EXPERIMENTAL

HC010 0.15mg/kg to 20mg/kg Q2w/28d intravenous infusion

Drug: HC010

dose expansion phase

EXPERIMENTAL

Fixed dose of HC010 Q2w/28d intravenous infusion

Drug: HC010

Interventions

HC010 DRUG

HC010 Q2W/28d intravenous infusion

dose expansion phase; dose-escalation phase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN, renal function and cardiopulmonary function are basically normal.
• Subjects 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 childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the HC010

You may not qualify if:

• 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;
• 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 (VEGF) targets in prior antitumor therapy;
• 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 resected carcinoma in situ;
• Patients with active autoimmune disease, or a history of autoimmune disease；
• 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;

Sponsors & Collaborators

• HC Biopharma Inc.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular; Colorectal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Langxi Zhang, Ph.D

CONTACT

+86 21 5043 3368; langxi.zhang@btyy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: March 27, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)