HC010 with chemotherapy for advanced gastrointestinal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Lin Shen
• Email: doctorshenlin@sina.cn
• Phone: 010-88196591

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Added tissue or liquid biopsy profiling to guide advanced solid tumor treatment

  This study tests how comprehensive genomic profiling from tumor tissue or blood can help tailor treatment decisions for adults with advanced solid tumors or primary CNS cancers at multiple centers.

  Recruiting at 14 sites The Belgian Society of Medical Oncology · Anderlecht and 13 other locations · NCT07713550

• EASE: A new approach to help adults with advanced cancer cope with fear of progression

  This study tests a written exposure-based coping program to see if it reduces fear of cancer progression and related distress in adults with advanced solid tumors.

  Recruiting at 2 sites University of Colorado, Boulder · Aurora, Colorado and 1 other locations · NCT07636200

• First-in-human test of ZE94-0605 for advanced solid tumors

  This first-in-human trial tests ZE94-0605, an oral CDK2 inhibitor, in adults with advanced or metastatic solid tumors to find a safe dose and explore early signs of activity.

  Recruiting at 3 sites Phase 1 Eilean Therapeutics · Kogarah, New South Wales and 2 other locations · NCT07524140

• BNT3214 for adults with advanced solid tumors

  This trial will test whether the experimental drug BNT3214 is safe and shows signs of benefit for adults whose advanced solid tumors have progressed after standard treatments.

  Recruiting at 6 sites Phase 1/2 BioNTech SE · Clayton and 15 other locations · NCT07455734

• Phase II LM-24C5 treatment for CEACAM5-positive advanced solid tumors

  This trial tests whether giving LM-24C5 together with other therapies is safe and helps adults (18–80) who have CEACAM5-positive advanced solid tumors.

  Recruiting Phase 2 LaNova Medicines Limited · Fuzhou, Fujian and 1 other locations · NCT07387081

• HC010 combined with chemotherapy for advanced lung cancer — Phase Ib dosing and safety

  This trial tests whether adding HC010 to standard chemotherapy is safe and finds the best dose in people with advanced lung cancer while looking for early signs it helps.

  Recruiting Phase 1 HC Biopharma Inc. · Guangzhou, Guangdong · NCT07381829

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.