Advanced Solid TumorPhase 1NCT06304571
A Study of HC006 in Subjects With Advanced Solid Tumors
A Phase 1 study testing HC006 in people with Advanced Solid Tumor, run by HC Biopharma Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HC006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2024to 16 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Ye Guo, MD, pattrickguo@gmail.com
About this study
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
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.
Read the 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
- Being tested
- HC006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC006Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| HC006 Dose Escalation | Experimental | Not described Receives: Drug: HC006 |
| HC006 Dose Expansion | Experimental | Not described Receives: Drug: HC006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol
Incidence of Dose Limiting Toxicities(DLTs)
Measured: up to 24 months
Number of participants with adverse events(AEs) as assessed by CTCAE v5.0
Incidence of adverse events(AEs)
Measured: up to 24 months
Number of participants with Serious adverse events(SAEs)as assessed by CTCAE v5.0
Incidence of Serious adverse events(SAEs)
Measured: up to 24 months
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
Measured: up to 24 months
Secondary outcomes (11)
Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)
Maximum serum concentration (Cmax)
Measured: up to 24 months
PK Parameter:Time to reach Cmax (Tmax)
Time to reach Cmax (Tmax)
Measured: up to 24 months
PK Parameter:Area Under the Concentration-time Curve (AUC)
Area Under the Concentration-time Curve (AUC)
Measured: up to 24 months
Immunogenicity
Incidence of anti-drug antibodies (ADAs) to HC006
Measured: 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.
Measured: 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.
Measured: up to 24 months
Overall Survival (OS)
Time from first dose of the investigational drug to death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Feb 2024
- Primary completion15 Mar 2026 (estimated)
- Study completion16 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HC Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304571
- Sponsor's protocol ID
- HC006-001
- Status last verified
- Apr 2025
- First submitted
- 5 Mar 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06304571
- Acronym / sponsor ID
- HC006-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 16 Jul 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HC006 Dose Escalation | Experimental | Drug: HC006 |
| HC006 Dose Expansion | Experimental | Drug: HC006 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC006Specified dose on specified days | Drug | HC006 Dose Escalation, HC006 Dose Expansion |
Primary outcome
Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol
Time frame: up to 24 months
Incidence of Dose Limiting Toxicities(DLTs)
Number of participants with adverse events(AEs) as assessed by CTCAE v5.0
Time frame: up to 24 months
Incidence of adverse events(AEs)
Number of participants with Serious adverse events(SAEs)as assessed by CTCAE v5.0
Time frame: up to 24 months
Incidence of Serious adverse events(SAEs)
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
Time frame: up to 24 months
Percentage of Participants Experiencing Laboratory and ECG Abnormalities According to the NCI CTCAE v5.0
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC006 in people with Advanced Solid Tumor, run by HC Biopharma Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact langxi Zhang, PhD (00-86-021-50433368, langxi.zhang@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities(DLTs)as assessed by protocol (time frame: up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.