Advanced CancerPhase 1NCT06963814
Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
A Phase 1 study testing HC006 and KEYTRUDA ®( Pembrolizumab) in people with Advanced Cancer, run by HC Biopharma Inc. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- HC006 and KEYTRUDA ®( Pembrolizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to 30 May 2027
- 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
- Fully understand this trial and voluntarily sign the informed consent form;
- Advanced solid tumors diagnosed by histology or cytopathology;
- Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;
- At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
- Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;
- The expected survival time is more than 3 months;
- Adequate organ and bone marrow function
- Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of investigational product and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).
Who cannot join
- Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
- Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
- Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
- Conditions may significantly affect the autoimmune status;
- Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:
- Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;
- Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial;
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, 200123
Ye Guo, MD, pattrickguo@gmail.com
About this study
Official title: A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.
Read the detailed description
HC006 is an IgG1 monoclonal antibody targeting CCR8, which can specifically clear CCR8-positive tumor infiltrating Treg cells without affecting CD8+ T cell function, thus enhancing the anti-tumor immune response. It has a synergistic effect on anti-tumor effects when combined with PD-1 inhibitors. Based on the existing evidence-based medicine, HC006 combined with PD-1 inhibitors is expected to provide additional treatment benefits in addition to PD-1 inhibitors for a variety of malignant solid tumors including colorectal cancer, head and neck squamous cell carcinoma, gastric cancer, non-small cell lung cancer, cervical cancer, breast cancer, esophageal cancer, pancreatic cancer, ovarian cancer, melanoma, urothelial cancer and renal cancer.
- Conditions
- Advanced Cancer
- Being tested
- HC006, KEYTRUDA ®( Pembrolizumab)
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
KEYTRUDA ®( Pembrolizumab)Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| HC006+ keytruda Dose Escalation | Experimental | Not described Receives: Drug: HC006; Drug: KEYTRUDA ®( Pembrolizumab) |
| HC006 +keytruda Dose Expansion | Experimental | Not described Receives: Drug: HC006; Drug: KEYTRUDA ®( Pembrolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities(DLTs)
Incidence of Dose Limiting Toxicities(DLTs)
Measured: up to 24 months
Secondary outcomes (3)
Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)
Maximum serum concentration (Cmax)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start4 Jul 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 252 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
- NCT06963814
- Sponsor's protocol ID
- BT-HC006-102
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial
- ClinicalTrials.gov ID
- NCT06963814
- Acronym / sponsor ID
- BT-HC006-102
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 9 May 2025 (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.
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.
Detailed description
HC006 is an IgG1 monoclonal antibody targeting CCR8, which can specifically clear CCR8-positive tumor infiltrating Treg cells without affecting CD8+ T cell function, thus enhancing the anti-tumor immune response. It has a synergistic effect on anti-tumor effects when combined with PD-1 inhibitors. Based on the existing evidence-based medicine, HC006 combined with PD-1 inhibitors is expected to provide additional treatment benefits in addition to PD-1 inhibitors for a variety of malignant solid tumors including colorectal cancer, head and neck squamous cell carcinoma, gastric cancer, non-small cell lung cancer, cervical cancer, breast cancer, esophageal cancer, pancreatic cancer, ovarian cancer, melanoma, urothelial cancer and renal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HC006+ keytruda Dose Escalation | Experimental | Drug: HC006, Drug: KEYTRUDA ®( Pembrolizumab) |
| HC006 +keytruda Dose Expansion | Experimental | Drug: HC006, Drug: KEYTRUDA ®( Pembrolizumab) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully understand this trial and voluntarily sign the informed consent form;
- Advanced solid tumors diagnosed by histology or cytopathology;
- Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;
- At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
- Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;
Key exclusion criteria (7 listed)
- Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
- Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
- Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
- Conditions may significantly affect the autoimmune status;
- Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:
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 +keytruda Dose Expansion, HC006+ keytruda Dose Escalation |
| KEYTRUDA ®( Pembrolizumab)Specified dose on specified days | Drug | HC006 +keytruda Dose Expansion, HC006+ keytruda Dose Escalation |
Primary outcome
Incidence of Dose Limiting Toxicities(DLTs)
Time frame: up to 24 months
Incidence of Dose Limiting Toxicities(DLTs)
3 secondary outcomes
Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)
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
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 17 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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 and KEYTRUDA ®( Pembrolizumab) in people with Advanced Cancer, 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 8 inclusion and 7 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 17 Jul 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 Ke Yao, master (028-85142721, ke.yao@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose Limiting Toxicities(DLTs) (time frame: up to 24 months). 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 17 Jul 2025.