HC010 with chemotherapy for advanced gastrointestinal cancers

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.

This Phase Ib test will see if adding HC010 to common chemotherapy is safe and shows early benefit for people with advanced gastrointestinal cancers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 331 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: HC Biopharma Inc. (Industry-sponsored)
• Drugs / interventions: immunotherapy, chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07477743 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label Phase Ib dose range-finding trial with multiple cohort dose-expansion arms testing HC010 in combination with chemotherapy regimens (including paclitaxel, oxaliplatin, and capecitabine) and HC006 in patients with advanced gastrointestinal cancers. The study will escalate doses to define tolerability and pharmacokinetics, then expand selected dose cohorts to collect preliminary efficacy and safety data. Key entry requirements include measurable disease per RECIST v1.1, ECOG performance status 0–1, expected survival >3 months, and adequate organ and marrow function. The main goal is to determine a recommended dose for subsequent studies while monitoring adverse events and early signs of tumor response.

Who should consider this trial

Good fit: Adults with unresectable or metastatic gastrointestinal cancers who have at least one measurable lesion, ECOG 0–1, adequate organ function, and an expected survival beyond three months are the intended candidates.

Not a fit: Patients with only brain lesions as target lesions, an ECOG score of 2 or higher, very limited life expectancy (≤3 months), or significant organ dysfunction are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, combining HC010 with standard chemotherapy could increase treatment activity or help control disease longer for some patients with advanced gastrointestinal cancers.

How similar studies have performed: Adding novel targeted agents to chemotherapy has led to meaningful benefits in some cancer types in later-phase studies, but many early-phase combinations remain unproven and require dose-finding work like this trial.

Eligibility criteria

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.

  11\. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.

  12\. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.

  13\. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Lin Shen

Conditions Advanced Solid Tumor Cancer