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

RECRUITINGPHASE1

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

Phase Ib Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HC010 Combinations in Patients With Advanced Solid Tumors and Determine the Recommended Dose for Subsequent Studies.

NCT07477743•HC Biopharma Inc.

View on ClinicalTrials.gov

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.

Detailed Description

This clinical trial is a multicenter, open-label, dose range-finding and multiple cohort dose expansion Phase Ib Clinical Trial- Gastrointestinal Cancer Population. The objective of this study is 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. 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.
•3\. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).
•4\. 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.
•5\. 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.

Exclusion Criteria

•1.Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.
•2\. Combination of brain metastasis, meningeal metastasis and spinal cord compression.
•3\. 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.
•4\. 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.
•5\. 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.
•6\. 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.
•7\. Subjects with other malignant tumors within 5 years before the first dose of study drug.
•8\. 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.
•9\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.
•10\. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.
+3 more criteria

Locations (1)

Beijing Cancer Hospital

Beijing, China

Key Dates

Start Date

March 17, 2026

Primary Completion Date

December 31, 2027

Completion Date

March 31, 2028

Last Updated

March 17, 2026

Enrollment

331

ESTIMATED participants

Conditions

Advanced Solid Tumor Cancer

Interventions

HC010

DRUG

Paclitaxel

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

HC006

DRUG

Contacts

Lin Shen

CONTACT

010-88196591 doctorshenlin@sina.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma

Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GH2616 in Subjects With Advanced Solid Tumor.