A Study of HC006 in Subjects With Advanced Solid Tumors

NCT ID: NCT06304571

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2026-07-16

Brief 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HC006 Dose Escalation

Group Type: EXPERIMENTAL

HC006

Intervention Type: DRUG

Specified dose on specified days

HC006 Dose Expansion

Group Type: EXPERIMENTAL

HC006

Intervention Type: DRUG

Specified dose on specified days

Interventions

HC006

Specified dose on specified days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HC Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

langxi Zhang, PhD

Role: CONTACT

langxi.zhang@btyy.com

00-86-021-50433368

Facility Contacts

Ye Guo, MD

Role: primary

pattrickguo@gmail.com

Other Identifiers

HC006-001

Identifier Type: -

Identifier Source: org_study_id