A Study of HC006 in Subjects With Advanced Solid Tumors

A Phase I, Open-label, Dose-Escalation and Dose-expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of HC006 in Advanced Solid Tumor Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: HC006

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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: langxi Zhang, PhD; Phone Number: 00-86-021-50433368; Email: langxi.zhang@btyy.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital
      • Contact: Ye Guo, MD; Email: pattrickguo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HC006 Dose Escalation	Drug: HC006; Specified dose on specified days
Experimental: HC006 Dose Expansion	Drug: HC006; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose Limiting Toxicities(DLTs)	Incidence of Dose Limiting Toxicities(DLTs)	up to 24 months
Incidence of adverse events(AEs)	Incidence of adverse events(AEs)	up to 24 months
Incidence of Serious adverse events(SAEs)	Incidence of Serious adverse events(SAEs)	up to 24 months
Clinically Significant changes in safety assessments	Clinically Significant changes in safety assessments	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)	Maximum serum concentration (Cmax)	up to 24 months
PK Parameter:Time to reach Cmax (Tmax)	Time to reach Cmax (Tmax)	up to 24 months
PK Parameter:Area Under the Concentration-time Curve (AUC)	Area Under the Concentration-time Curve (AUC)	up to 24 months
Immunogenicity	Incidence of anti-drug antibodies (ADAs) to HC006	up to 24 months
Objective Response Rate (ORR) per RECIST 1.1	The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.	up to 24 months
progression-Free Survival (PFS) per RECIST 1.1	Time from first dose of the investigational drug to PD or death from any cause.	up to 24 months
Overall Survival (OS)	Time from first dose of the investigational drug to death from any cause.	up to 24 months
Disease Control Rate (DCR) per RECIST 1.1	The sum of proportions of subjects who achieved CR, PR, and SD in imaging evaluation.	up to 24 months
Duration of response (DOR) per RECIST 1.1	Time from the first evaluated CR or PR until PD or death from any cause.	up to 24 months
Time to progression (TTP) per RECIST 1.1	Time from first dose of the investigational drug to the tumor evaluation of PD.	up to 24 months
Time To Response (TTR) per RECIST 1.1	Time from first dose of the investigational drug to the first tumor evaluation of CR or PR.	up to 24 months

Collaborators and Investigators

• Sponsor: HC Biopharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): July 16, 2026

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HC006-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No