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

Official title

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.

Overview

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.

Interventions

• Drug HC010
  HC010 once every 3 weeks (Q3W) by intravenous drip
• Drug Paclitaxel
  the combination chemotherapy regimens are all commonly used in clinical practice
• Drug Oxaliplatin
  the combination chemotherapy regimens are all commonly used in clinical practice
• Drug Capecitabine
  the combination chemotherapy regimens are all commonly used in clinical practice
• Drug HC006
  HC006 once every 3 weeks (Q3W) by intravenous drip

Primary outcome measures

• Incidence of dose-limiting toxicities (DLTs) [Time frame: From first dose to 21 days]

Secondary outcome measures (6)

• Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria [Time frame: Up to approximately 2 years]
• Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria [Time frame: Up to approximately 2 years]
• Maximum concentration (Cmax) of HC010 [Time frame: Up to approximately 2 years]
• Number of positive cases of HC010 anti-drug antibody (ADA) [Time frame: Up to approximately 2 years]
• Area under the curve (AUC) of HC010 [Time frame: Up to approximately 2 years]
• Number of participants with adverse events (AEs) [Time frame: Up to approximately 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07477743 · BT-HC010-102-B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗