Advanced Solid Tumor CancerPhase 1NCT07381829
A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer
A Phase 1 study testing HC010, Paclitaxel (Chemotherapy) and Pemetrexed in people with Advanced Solid Tumor Cancer, run by HC Biopharma Inc. at 1 site in China.
Trial summary
Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor Cancer
- What is being tested?
- HC010, Paclitaxel (Chemotherapy) and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2025to 30 Dec 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
- 1. Fully understand this trial and voluntarily sign the informed consent form.
- 2. For locally recurrent or metastatic non-resectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions, while the dose-expansion stage is limited to NSCLC without standard of care, NSCLC with EGFR-sensitive mutations and progressing after adequate EGFR-TKI therapy. First-line population with driver gene negative non-small cell lung cancer and first-line population with extensive small cell lung cancer.
- 3. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).
- 4. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.
- 5. The expected survival time is more than 3 months.
- 6. Adequate organ and bone marrow function.
- 7. Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the investigational drug 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
- 1. Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.
- 2. Combination of brain metastasis, meningeal metastasis and spinal cord compression.
- 3. Prior concurrent 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) target drugs.
- 4. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.
- 5. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.
- 6. Concurrent with severe, uncontrolled and unrecovered acute and chronic diseases, such as acute coronary syndrome, uncontrolled hypertension, serious or poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding tendency or coagulation disorders within the first 6 months.
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- 7. Subjects with other malignant tumors within 5 years before the first dose of study drug.
- 8. 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.
- 9. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.
- 10. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.
- 11. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.
- 12. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.
- 13. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.
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, 020-87343458, zhangli@sysucc.org.cn
About this study
Official title: Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of the Combination Therapy With HC010 for Injection in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose Range-Finding and Multiple Cohort Dose Expansion Phase Ib Clinical Trial-Lung Cancer Population
Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
Read the detailed description
This clinical trial is a multicenter, open-label, dose range-finding and multiple cohort dose expansion Phase Ib Clinical Trial-Lung Cancer Population.The goal of this study is to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
- Conditions
- Advanced Solid Tumor Cancer
- Being tested
- HC010, Paclitaxel (Chemotherapy), Pemetrexed, Etoposide, Carboplatin/Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC010Drug
HC010 once every 3 weeks (Q3W) by intravenous drip
Paclitaxel (Chemotherapy)Drug
the combination chemotherapy regimens are all commonly used in clinical practice
PemetrexedDrug
the combination chemotherapy regimens are all commonly used in clinical practice
EtoposideDrug
the combination chemotherapy regimens are all commonly used in clinical practice
Carboplatin/CisplatinDrug
the combination chemotherapy regimens are all commonly used in clinical practice
DocetaxelDrug
the combination chemotherapy regimens are all commonly used in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| HC010 + Docetaxel | Experimental | HC010 once every 3 weeks (Q3W) by intravenous drip Receives: Drug: HC010; Drug: Docetaxel |
| HC010 + Paclitaxel + Carboplatin/Cisplatin | Experimental | HC010 once every 3 weeks (Q3W) by intravenous drip Receives: Drug: HC010; Drug: Paclitaxel (Chemotherapy); Drug: Carboplatin/Cisplatin |
| HC010 + Pemetrexed + Carboplatin/Cisplatin | Experimental | HC010 once every 3 weeks (Q3W) by intravenous drip Receives: Drug: HC010; Drug: Pemetrexed; Drug: Carboplatin/Cisplatin |
| HC010 + Etoposide + Carboplatin/Cisplatin | Experimental | HC010 once every 3 weeks (Q3W) by intravenous drip Receives: Drug: HC010; Drug: Etoposide; Drug: Carboplatin/Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: From first dose to 21 days
Secondary outcomes (6)
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria;
Measured: Up to approximately 2 years
Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria
Measured: Up to approximately 2 years
Maximum concentration (Cmax) of HC010
Measured: Up to approximately 2 years
Number of positive cases of HC010 anti-drug antibody (ADA)
Measured: Up to approximately 2 years
Area under the curve (AUC) of HC010
Measured: Up to approximately 2 years
Number of participants with adverse events (AEs)
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start27 Oct 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 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 Tumor 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
- 328 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
- NCT07381829
- Sponsor's protocol ID
- BT-HC010-102-A
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of the Combination Therapy With HC010 for Injection in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose Range-Finding and Multiple Cohort Dose Expansion Phase Ib Clinical Trial-Lung Cancer Population
- ClinicalTrials.gov ID
- NCT07381829
- Acronym / sponsor ID
- BT-HC010-102-A
- Conditions
- Advanced Solid Tumor Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
Detailed description
This clinical trial is a multicenter, open-label, dose range-finding and multiple cohort dose expansion Phase Ib Clinical Trial-Lung Cancer Population.The goal of this study is to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HC010 + Docetaxel | Experimental | Drug: HC010, Drug: DocetaxelHC010 once every 3 weeks (Q3W) by intravenous drip |
| HC010 + Paclitaxel + Carboplatin/Cisplatin | Experimental | Drug: HC010, Drug: Paclitaxel (Chemotherapy), Drug: Carboplatin/CisplatinHC010 once every 3 weeks (Q3W) by intravenous drip |
| HC010 + Pemetrexed + Carboplatin/Cisplatin | Experimental | Drug: HC010, Drug: Pemetrexed, Drug: Carboplatin/CisplatinHC010 once every 3 weeks (Q3W) by intravenous drip |
| HC010 + Etoposide + Carboplatin/Cisplatin | Experimental | Drug: HC010, Drug: Etoposide, Drug: Carboplatin/CisplatinHC010 once every 3 weeks (Q3W) by intravenous drip |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Fully understand this trial and voluntarily sign the informed consent form.
- 2. For locally recurrent or metastatic non-resectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions, while the dose-expansion stage is limited to NSCLC without standard of care, NSCLC with EGFR-sensitive mutations and progressing after adequate EGFR-TKI therapy. First-line population with driver gene negative non-small cell lung cancer and first-line population with extensive small cell lung cancer.
- 3. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).
- 4. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.
- 5. The expected survival time is more than 3 months.
Key exclusion criteria (13 listed)
- 1. Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.
- 2. Combination of brain metastasis, meningeal metastasis and spinal cord compression.
- 3. Prior concurrent 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) target drugs.
- 4. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.
- 5. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.
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 once every 3 weeks (Q3W) by intravenous drip | Drug | HC010 + Docetaxel, HC010 + Etoposide + Carboplatin/Cisplatin, HC010 + Paclitaxel + Carboplatin/Cisplatin, HC010 + Pemetrexed + Carboplatin/Cisplatin |
| Paclitaxel (Chemotherapy)the combination chemotherapy regimens are all commonly used in clinical practice | Drug | HC010 + Paclitaxel + Carboplatin/Cisplatin |
| Pemetrexedthe combination chemotherapy regimens are all commonly used in clinical practice | Drug | HC010 + Pemetrexed + Carboplatin/Cisplatin |
| Etoposidethe combination chemotherapy regimens are all commonly used in clinical practice | Drug | HC010 + Etoposide + Carboplatin/Cisplatin |
| Carboplatin/Cisplatinthe combination chemotherapy regimens are all commonly used in clinical practice | Drug | HC010 + Etoposide + Carboplatin/Cisplatin, HC010 + Paclitaxel + Carboplatin/Cisplatin, HC010 + Pemetrexed + Carboplatin/Cisplatin |
| Docetaxelthe combination chemotherapy regimens are all commonly used in clinical practice | Drug | HC010 + Docetaxel |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: From first dose to 21 days
6 secondary outcomes
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria;
Time frame: Up to approximately 2 years
Disease control rate (DCR) as assessed by the investigator according to RECIST 1.1 criteria
Time frame: Up to approximately 2 years
Maximum concentration (Cmax) of HC010
Time frame: Up to approximately 2 years
Number of positive cases of HC010 anti-drug antibody (ADA)
Time frame: Up to approximately 2 years
Area under the curve (AUC) of HC010
Time frame: Up to approximately 2 years
Number of participants with adverse events (AEs)
Time frame: Up to approximately 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 2 Feb 2026.
- 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, Paclitaxel (Chemotherapy) and Pemetrexed in people with Advanced Solid Tumor 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 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 2 Feb 2026. 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 QiQi huang Huang, master (+8618221247718, qiqi.huang@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: From first dose to 21 days). 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 2 Feb 2026.