Advanced Solid TumorPhase 1NCT06307925
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
A Phase 1 study testing HC010 in people with Advanced Solid Tumor, run by HC Biopharma Inc. at 1 site in China.
Trial summary
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients 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?
- HC010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to 31 Dec 2025
- 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
- Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF).
- Age ≥18 and ≤75, male or female.
- Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
- Participants must have at least one measurable lesion according to RECIST Version1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
- Hepatocellular carcinoma patients with Child-Pugh score ≤ 7
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- Expected survival time is at least 3 months
- Adequate organ function: neutrophil count≥1.5×109/L,platelet count ≥100×109/L,hemoglobin≥90g/L,alanine aminotransferase and aspartate aminotransferase ≤2.5×upper limit of normal (ULN); patients with hepatocellular carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN, renal function and cardiopulmonary function are basically normal.
- Subjects should provide, whenever possible, freshly obtained or archived tumor tissue sample prior to study treatment that can be used for biomarker analysis
- Participants of childbearing potential (males and females) must agree to effective contraception for at least 90 days from the time of signing the informed consent form to the time of the last dose; females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the HC010
Who cannot join
- Receipt of any interventional clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of the HC010; Receipt of herbal or proprietary Chinese medicine with an anti-tumor indication within 2 weeks prior to the first dose of HC010;
- Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;
- Receipt of systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks prior to the first dose of HC010;
- Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;
- Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010;
- Patients who have received biomolecule therapy for anti-programmed death receptor 1 (PD-1)/programmed death ligand (PD-L1), anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) targets in prior antitumor therapy;
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- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade≤1;
- History of immune-related adverse event (irAE) leading to permanent discontinuation from prior immunotherapy ,or grade ≥3 toxicity related to anti-angiogenic therapy from prior anti-angiogenic therapy；
- Previous allogeneic hematopoietic stem cell transplantation or organ transplantation；
- Patients with known active brain metastases, or the presence of meningeal metastases, spinal cord compression, or molluscum contagiosum disease；
- Combination of other malignancies within 5 years prior to the first dose; excludes radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, papillary thyroid carcinoma and/or radically resected carcinoma in situ;
- Patients with active autoimmune disease, or a history of autoimmune disease；
- Infections: 1) active hepatitis B and C; Note: HBsAg and/or hepatitis B core antibody (HBcAb) positive individuals with HBV DNA ≥500 IU/ml (≥2000 IU/ml in patients with hepatocellular carcinoma) tested within 28 days prior to the initiation of treatment are eligible for inclusion.2) known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); 3) known active syphilis; 4) active tuberculosis; 5) active infection within two weeks prior to first dose of HC010;
- Unstable systemic disease, including but not limited to, severe cardiovascular disease; pleural effusion, pericardial effusion or peritoneal effusion requiring repeated drainage;
- Severe bleeding tendencies or coagulation disorders;
- History of non-infectious pneumonia/interstitial lung disease requiring systemic glucocorticoid therapy;
- Females who are pregnant or breastfeeding;
- Inappropriate for this study in the opinion of the investigator;
- History of systemic hypersensitivity or anaphylaxis to any component of HC010.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Li Zhang, MD, +86 139 0228 2893, zhangli@sysucc.org.cn
About this study
Official title: A Phase I Open-label, Multi-center, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
Read the detailed description
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.Enrollment is for patients with advanced adult solid tumors (including but not limited to non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer, triple-negative breast cancer, gastric cancer/gastroesophageal junction adenocarcinoma, ovarian cancer, pancreatic cancer, bladder cancer, and renal cancer) who have either failed to respond to standard of care or who are unable to receive/do not have access to standard of care.Subjects received HC010 monotherapy by intravenous infusion every two weeks in 1 cycle of 28 days, and were treated until completion of 2 years of study treatment, disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or fulfillment of other criteria for termination of treatment, whichever occurred first. The primary study endpoints were safety and tolerability, maximum tolerated dose (MTD) and/or recommended dose for phase II clinical studies (RP2D); secondary endpoint indicators included pharmacokinetic indicators, efficacy indicators [objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)], immunogenicity indicators such as anti-drug antibody (ADA) and neutralizing antibody (Nab). Exploratory endpoints included the pharmacokinetic (PD) index of HC010, the relationship between peripheral blood T-cell receptor occupancy (RO) and safety and efficacy, as well as the correlation between PD-L1 expression level in tumor tissues and efficacy.
- Conditions
- Advanced Solid Tumor
- Being tested
- HC010
- Keywords
- advanced solid tumor, Non-small cell lung cancer, Hepatocellular carcinoma, colorectal cancer, cervical cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular, Colorectal Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC010Drug
HC010 Q2W/28d intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| dose-escalation phase | Experimental | HC010 0.15mg/kg to 20mg/kg Q2w/28d intravenous infusion Receives: Drug: HC010 |
| dose expansion phase | Experimental | Fixed dose of HC010 Q2w/28d intravenous infusion Receives: Drug: HC010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity
Incidence of dose-limiting toxicity
Measured: 28 days
Adverse events
Adverse events
Measured: 2 years
serious adverse events
serious adverse events
Measured: 2 years
Maximum Tolerated Dose
Maximum Tolerated Dose
Measured: 2 years
Recommended Dose for Phase II Clinical Studies
Recommended Dose for Phase II Clinical Studies
Measured: 2 years
Secondary outcomes (9)
pharmacokinetics:Cmax
pharmacokinetics:Cmax
Measured: 2 years
Objective response rate
Objective response rate (ORR)
Measured: 2 years
duration of response
duration of response (DoR)
Measured: 2 years
progression-free survival
progression-free survival
Measured: 2 years
overall survival
overall survival
Measured: 2 years
Disease control rate
Disease control rate
Measured: 2 years
pharmacokinetics:AUC0-last
pharmacokinetics:AUC0-last
Measured: 2 years
pharmacokinetics:tmax
pharmacokinetics:tmax
Measured: 2 years
pharmacokinetics:Vd
pharmacokinetics:Vd
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start27 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 122 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
- NCT06307925
- Sponsor's protocol ID
- HC010-001
- Status last verified
- May 2025
- First submitted
- 6 Mar 2024
- Last updated
- 13 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Multi-center, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06307925
- Acronym / sponsor ID
- HC010-001
- Conditions
- Advanced Solid Tumor
- Keywords
- advanced solid tumor, Non-small cell lung cancer, Hepatocellular carcinoma, colorectal cancer, cervical cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 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.
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
Detailed description
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.Enrollment is for patients with advanced adult solid tumors (including but not limited to non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer, triple-negative breast cancer, gastric cancer/gastroesophageal junction adenocarcinoma, ovarian cancer, pancreatic cancer, bladder cancer, and renal cancer) who have either failed to respond to standard of care or who are unable to receive/do not have access to standard of care.Subjects received HC010 monotherapy by intravenous infusion every two weeks in 1 cycle of 28 days, and were treated until completion of 2 years of study treatment, disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, death, or fulfillment of other criteria for termination of treatment, whichever occurred first. The primary study endpoints were safety and tolerability, maximum tolerated dose (MTD) and/or recommended dose for phase II clinical studies (RP2D); secondary endpoint indicators included pharmacokinetic indicators, efficacy indicators [objective response rate (ORR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)], immunogenicity indicators such as anti-drug antibody (ADA) and neutralizing antibody (Nab). Exploratory endpoints included the pharmacokinetic (PD) index of HC010, the relationship between peripheral blood T-cell receptor occupancy (RO) and safety and efficacy, as well as the correlation between PD-L1 expression level in tumor tissues and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose-escalation phase | Experimental | Drug: HC010HC010 0.15mg/kg to 20mg/kg Q2w/28d intravenous infusion |
| dose expansion phase | Experimental | Drug: HC010Fixed dose of HC010 Q2w/28d intravenous infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF).
- Age ≥18 and ≤75, male or female.
- Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available.
- Participants must have at least one measurable lesion according to RECIST Version1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
Key exclusion criteria (19 listed)
- Receipt of any interventional clinical trial treatment or other systemic chemotherapy, radiotherapy, etc. within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of the HC010; Receipt of herbal or proprietary Chinese medicine with an anti-tumor indication within 2 weeks prior to the first dose of HC010;
- Underwent surgery, experienced severe trauma, etc,within 4 weeks prior to the first administration of HC010 ;
- Receipt of systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 2 weeks prior to the first dose of HC010;
- Receipt of immunomodulatory drugs within 2 weeks prior to the first dose of HC010;
- Receipt of live attenuated vaccination within 4 weeks prior to the first dose of HC010;
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 |
|---|---|---|
| HC010HC010 Q2W/28d intravenous infusion | Drug | dose expansion phase, dose-escalation phase |
Primary outcome
Incidence of dose-limiting toxicity
Time frame: 28 days
Incidence of dose-limiting toxicity
Adverse events
Time frame: 2 years
Adverse events
serious adverse events
Time frame: 2 years
serious adverse events
Maximum Tolerated Dose
Time frame: 2 years
Maximum Tolerated Dose
Recommended Dose for Phase II Clinical Studies
Time frame: 2 years
Recommended Dose for Phase II Clinical Studies
9 secondary outcomes
pharmacokinetics:Cmax
Time frame: 2 years
Objective response rate
Time frame: 2 years
duration of response
Time frame: 2 years
progression-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
Disease control rate
Time frame: 2 years
pharmacokinetics:AUC0-last
Time frame: 2 years
pharmacokinetics:tmax
Time frame: 2 years
pharmacokinetics:Vd
Time frame: 2 years
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 13 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 HC010 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 10 inclusion and 19 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 13 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, Ph.D (+86 21 5043 3368, langxi.zhang@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 toxicity (time frame: 28 days). The study lists 5 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 13 May 2025.