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Recruiting NCT06304571

A Study of HC006 in Subjects With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HC006.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug HC006
    Specified dose on specified days

Primary outcome measures

  • Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol [Time frame: up to 24 months]
  • Number of participants with adverse events(AEs) as assessed by CTCAE v5.0 [Time frame: up to 24 months]
  • Number of participants with Serious adverse events(SAEs)as assessed by CTCAE v5.0 [Time frame: up to 24 months]
  • Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0 [Time frame: up to 24 months]
Secondary outcome measures (11)
  • Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax) [Time frame: up to 24 months]
  • PK Parameter:Time to reach Cmax (Tmax) [Time frame: up to 24 months]
  • PK Parameter:Area Under the Concentration-time Curve (AUC) [Time frame: up to 24 months]
  • Immunogenicity [Time frame: up to 24 months]
  • Objective Response Rate (ORR) per RECIST 1.1 [Time frame: up to 24 months]
  • progression-Free Survival (PFS) per RECIST 1.1 [Time frame: up to 24 months]
  • Overall Survival (OS) [Time frame: up to 24 months]
  • Disease Control Rate (DCR) per RECIST 1.1 [Time frame: up to 24 months]
  • Duration of response (DOR) per RECIST 1.1 [Time frame: up to 24 months]
  • Time to progression (TTP) per RECIST 1.1 [Time frame: up to 24 months]
  • Time To Response (TTR) per RECIST 1.1 [Time frame: up to 24 months]

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.

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
  • Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT06304571 · HC006-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗