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Trial Title: A Study of HC006 in Subjects With Advanced Solid Tumors

NCT ID: NCT06304571

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HC006
Description: Specified dose on specified days
Arm group label: HC006 Dose Escalation
Arm group label: HC006 Dose Expansion

Summary: The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.

Detailed description: HC006, a novel therapeutic monoclonal antibody that specifically binds to human C-C motif chemokine receptor 8 (CCR8) and is designed to selectively deplete tumor-infiltrating T regulatory cells (Tregs) with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). In mouse tumor models, HC006 has demonstrated excellent antitumor activity and safety profile. This first-in-human (FIH) study will be conducted in two parts. In the Dose-Escalation part, testing will be done on up to 31 subjects to determine the maximum tolerated dose (MTD) and the recommended dose (RD). In the Dose-expansion part, we will evaluate the safety and efficacy of the recommended dose of HC006 in the treatment of advanced solid tumor subjects without standard therapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists. - At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion) - Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts. - Life expectancy ≥12 weeks - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Have adequate organ function as described in the protocol. - Agree to adopt effective contraceptive measures. Exclusion Criteria: - Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug. - Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug. - Use of any live attenuated vaccines within 28 days. - With primary central nervous system (CNS) tumors or unstable CNS metastases. - Have active or history of autoimmune disease or immunodeficiency disease. - With active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. - With any mental or cognitive impairment that may limit their understanding, implementation. - Major surgery within 4 weeks of study drug administration. - Have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion. - Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. - History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma. - Women who are pregnant or breastfeeding. - Other protocol defined exclusion criteria may apply.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai East Hospital

Address:
City: Shanghai
Zip: 200120
Country: China

Status: Recruiting

Contact:
Last name: Ye Guo, MD
Email: pattrickguo@gmail.com

Start date: February 27, 2024

Completion date: July 16, 2026

Lead sponsor:
Agency: HC Biopharma Inc.
Agency class: Industry

Source: HC Biopharma Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06304571

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