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A Study of HC006 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06304571
Recruitment Status : Recruiting
First Posted : March 12, 2024
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
HC Biopharma Inc.

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: HC006 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2024
Estimated Primary Completion Date : March 15, 2026
Estimated Study Completion Date : July 16, 2026

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




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities(DLTs) [ Time Frame: up to 24 months ]
    Incidence of Dose Limiting Toxicities(DLTs)

  2. Incidence of adverse events(AEs) [ Time Frame: up to 24 months ]
    Incidence of adverse events(AEs)

  3. Incidence of Serious adverse events(SAEs) [ Time Frame: up to 24 months ]
    Incidence of Serious adverse events(SAEs)

  4. Clinically Significant changes in safety assessments [ Time Frame: up to 24 months ]
    Clinically Significant changes in safety assessments


Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax) [ Time Frame: up to 24 months ]
    Maximum serum concentration (Cmax)

  2. PK Parameter:Time to reach Cmax (Tmax) [ Time Frame: up to 24 months ]
    Time to reach Cmax (Tmax)

  3. PK Parameter:Area Under the Concentration-time Curve (AUC) [ Time Frame: up to 24 months ]
    Area Under the Concentration-time Curve (AUC)

  4. Immunogenicity [ Time Frame: up to 24 months ]
    Incidence of anti-drug antibodies (ADAs) to HC006

  5. Objective Response Rate (ORR) per RECIST 1.1 [ Time Frame: up to 24 months ]
    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.

  6. progression-Free Survival (PFS) per RECIST 1.1 [ Time Frame: up to 24 months ]
    Time from first dose of the investigational drug to PD or death from any cause.

  7. Overall Survival (OS) [ Time Frame: up to 24 months ]
    Time from first dose of the investigational drug to death from any cause.

  8. Disease Control Rate (DCR) per RECIST 1.1 [ Time Frame: up to 24 months ]
    The sum of proportions of subjects who achieved CR, PR, and SD in imaging evaluation.

  9. Duration of response (DOR) per RECIST 1.1 [ Time Frame: up to 24 months ]
    Time from the first evaluated CR or PR until PD or death from any cause.

  10. Time to progression (TTP) per RECIST 1.1 [ Time Frame: up to 24 months ]
    Time from first dose of the investigational drug to the tumor evaluation of PD.

  11. Time To Response (TTR) per RECIST 1.1 [ Time Frame: up to 24 months ]
    Time from first dose of the investigational drug to the first tumor evaluation of CR or PR.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06304571


Contacts
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Contact: langxi Zhang, PhD 00-86-021-50433368 langxi.zhang@btyy.com

Locations
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China, Shanghai
Shanghai East Hospital Recruiting
Shanghai, Shanghai, China, 200120
Contact: Ye Guo, MD       pattrickguo@gmail.com   
Sponsors and Collaborators
HC Biopharma Inc.
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Responsible Party: HC Biopharma Inc.
ClinicalTrials.gov Identifier: NCT06304571    
Other Study ID Numbers: HC006-001
First Posted: March 12, 2024    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms