A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors

NCT07477743 | Recruiting Phase 1

• 1 other identifier: BT-HC010-102-B
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal cancer and determine the recommended dose for subsequent studies.

Conditions

Advanced Solid Tumor Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicities (DLTs)

  From first dose to 21 days

Secondary Outcomes (6)

• Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria

  Up to approximately 2 years

• Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria

  Up to approximately 2 years

• Maximum concentration (Cmax) of HC010

  Up to approximately 2 years

• Number of positive cases of HC010 anti-drug antibody (ADA)

  Up to approximately 2 years

• Area under the curve (AUC) of HC010

  Up to approximately 2 years

Study Arms (3)

HC010 + Paclitaxel

EXPERIMENTAL

HC010 once every 3 weeks (Q3W) by intravenous drip

Drug: HC010; Drug: Paclitaxel

HC010 + Oxaliplatin + Capecitabine

EXPERIMENTAL

HC010 once every 3 weeks (Q3W) by intravenous drip

Drug: HC010; Drug: Oxaliplatin; Drug: Capecitabine

HC010 + HC006

EXPERIMENTAL

HC010 once every 3 weeks (Q3W) by intravenous drip

Drug: HC010; Drug: HC006

Interventions

HC010 DRUG

HC010 once every 3 weeks (Q3W) by intravenous drip

HC010 + HC006; HC010 + Oxaliplatin + Capecitabine; HC010 + Paclitaxel

Paclitaxel DRUG

the combination chemotherapy regimens are all commonly used in clinical practice

HC010 + Paclitaxel

Oxaliplatin DRUG

the combination chemotherapy regimens are all commonly used in clinical practice

HC010 + Oxaliplatin + Capecitabine

Capecitabine DRUG

the combination chemotherapy regimens are all commonly used in clinical practice

HC010 + Oxaliplatin + Capecitabine

HC006 DRUG

HC006 once every 3 weeks (Q3W) by intravenous drip

HC010 + HC006

Eligibility Criteria

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

You may qualify if:

• \. Fully understand this trial and voluntarily sign the informed consent form. 2. For locally recurrent or metastatic unresectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions.
• \. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).
• \. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.
• \. The expected survival time is more than 3 months. 6. Have adequate organ and bone marrow functions. 7.For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration.

You may not qualify if:

• Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.
• \. Combination of brain metastasis, meningeal metastasis and spinal cord compression.
• \. Prior concurrent 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) target drugs.
• \. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.
• \. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.
• \. Concurrent with severe, uncontrolled and unrecovered acute and chronic diseases, such as acute coronary syndrome, uncontrolled hypertension, serious or poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding tendency or coagulation disorders within the first 6 months.
• \. Subjects with other malignant tumors within 5 years before the first dose of study drug.
• \. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial.
• \. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.
• \. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.
• \. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.
• \. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.
• \. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.

Sponsors & Collaborators

• HC Biopharma Inc.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Lin Shen

CONTACT

010-88196591; doctorshenlin@sina.cn

Study Design

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

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)