Solid TumorPhase 1/2NCT07069062
A Phase I/Ⅱ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors
A Phase 1/2 study testing Test product HY0001a for injection in people with Solid Tumor, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a multicenter, open-label, phase I/Ⅱ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Test product HY0001a for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to Sep 2027
- Phase
- Phase 1/2
- 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
- Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;
- ≥18 years old and ≤75 years old, gender: male or female;
- Patients have histological or cytological diagnosis with advanced solid tumors, cann't benefit from existing standard treatment options;The solid tumors included in the dose-expansion phase are as follows: Cohort 1: Esophageal cancer (patients who have previously received at least two lines of standard therapy);Cohort 2: Non-small cell lung cancer (patients who have previously received at least two lines of standard therapy);Cohort 3: Other tumors, such as cervical cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, breast cancer, etc. (patients who have failed or are intolerant to standard therapy).
- In the dose-escalation phase, patients must have evaluable tumor lesions; in the dose-expansion phase, patients must have at least one measurable tumor lesion (according to RECIST 1.1 version);
- In the dose-escalation phase, enrollment does not require the expression of CDCP1 (CUB domain containing protein 1). In the dose-expansion phase, enrollment is required to be positive for CDCP1
- Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
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- Life expectancy ≥3 months;
- Participant must have adequate main organ function;
- Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.
Who cannot join
- Having received anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks prior to the first administration of the study drug
- Known history of severe allergic reactions, or individuals who have experienced an allergic reaction to any of the excipients in the formulation of HY0001a for injection
- Participants who have previously failed treatment with antibody-drug conjugates (ADCs) that use microtubule inhibitors (Monomethyl auristatin E/Monomethyl auristatin F) as toxins
- Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;
- Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;
- Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;
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- Participants who are currently receiving, or who have received treatment with strong CYP3A4 or P-gp inducers or inhibitors within at least one week or five half-lives (whichever is longer) prior to the first administration of the study drug (limited to the dose-escalation phase).
- Participants with uncontrolled, unstable, or active central nervous system (CNS) metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and before radiological assessment
- Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure > 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator);
- Participants who have received allogenic tissue/organ transplants in the past;
- Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;
- Presence of ophthalmic diseases or symptoms that are deemed by the investigator as not meeting the eligibility criteria at the screening stage.
- Presence of sensory and/or motor neuropathy of Grade ≥2 during the screening period (according to CTCAE Version 5.0)
- Individuals with any of the following cardiac conditions: a. Left ventricular ejection fraction (LVEF) ≤ 50% (Echocardiography, abbreviated as ECHO); New York Heart Association (NYHA) Class III or IV congestive heart failure; b. Significant arrhythmias requiring treatment, including a QTcF (corrected QT interval) ≥ 480 ms measured by electrocardiogram (ECG) (QTcF = QT/(RR^0.33)); c. History of myocardial infarction, unstable angina, or clinically significant valvular disease within 6 months prior to dosing; other cardiac diseases deemed by the investigator as unsuitable for enrollment.
- Presence of other diseases that severely endanger the safety of the participant or affect the participant's ability to complete the trial, such as active gastrointestinal bleeding, active peptic ulcer, intestinal obstruction, intestinal ileus, renal failure, and uncontrolled diabetes (glycated hemoglobin (HbA1c) > 8% during the screening period)
- Participants with active infections deemed inappropriate for entry into the study by the investigator;
- Participants with uncontrolled third-space effusion requiring clinical intervention;
- Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes;
- Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified);
- Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration;
- Known history of hypersensitivity to any of the components of the test formulation.
- Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin.
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
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100143
Lin Shen, Doctor, 010-88196340, linshenpku@163.com
About this study
Official title: A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Clinical Efficacy of HY0001a for Injection in Patients With Advanced Malignant Solid Tumors
This is a multicenter, open-label, phase I/Ⅱ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.
Read the detailed description
This is a first-in-human (FIH), Phase I/II, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HY0001a for injection in patients with advanced/metastatic solid tumors. HY0001a for injection is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）. In addition, the maximum-tolerated dose and recommended Phase II dose for HY0001a for injection will be determined.
- Conditions
- Solid Tumor
- Being tested
- Test product HY0001a for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product HY0001a for injectionDrug
HY0010a for injection should be administered at the recommended dosage
| Study group | Role | What they receive |
|---|---|---|
| Test product HY0001a for injection | Experimental | HY0010a for injection should be administered at the recommended dosage Receives: Drug: Test product HY0001a for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)
Dose-Limiting Toxicity (DLT) will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: 21 days during the first 3-week cycle
Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 2 years
Dose Expansion (Part Two): Objective Response Rate (ORR)
Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)
Measured: Up to 2 years
Secondary outcomes (10)
Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: Up to 2 years
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free monomethyl auristatin E (MMAE, i.e., the toxin) Cmax
Maximum concentration observed (Cmax) observed from the pharmacokinetic profile
Measured: Up to 2 years
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free MMAE (i.e., the toxin) AUC
Area under the concentration versus time curve calculated using the trapezoidal method
Measured: Up to 2 years
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free MMAE (i.e., the toxin) T1/2
The time it takes for half the drug concentration to be eliminated calculated using slope of the terminal line
Measured: Up to 2 years
Dose Escalation (Part One): Objective Response Rate (ORR)
Proportion of participants who have a confirmed complete response (CR) or a Partial Response (PR) determined by Investigator per the Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
Measured: Up to 2 years
Dose Escalation and Expansion: Duration Of Response (DOR) assessed by investigator per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
Duration Of Response (DOR) is defined as the time from the measurement criteria are first met for complete response (CR) /Partial Response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease.
Measured: Up to 2 years
Dose Escalation and Expansion: Disease Control Rate (DCR) assessed by investigator per RECIST Version 1.1
Disease Control Rate is defined as the percentage of participants who have achieved CR or PR or have demonstrated stable disease
Measured: Up to 2 years
Dose Escalation and Expansion: Progression-Free Survival (PFS) assessed by investigator per RECIST Version 1.1
Progression-Free Survival (PFS) is defined as the time from the date of first administration of HY0001a to the date of the first documented disease progression determined by Investigator as per RECIST 1.1 or death from any cause, whichever occurs first
Measured: Up to 2 years
Dose Escalation and Expansion: Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first administration of HY0001a to death due to any cause
Measured: Up to 2 years
Immunogenicity assessment indicator: Anti-drug antibodies (ADA)
Incidence, duration, titer of serum anti-HY0001a ADA
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start21 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Sichuan Huiyu Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069062
- Sponsor's protocol ID
- HY0001-101
- Status last verified
- Mar 2026
- First submitted
- 26 Jun 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Clinical Efficacy of HY0001a for Injection in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07069062
- Acronym / sponsor ID
- HY0001-101
- Conditions
- Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Jul 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 a multicenter, open-label, phase I/Ⅱ study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of HY0001a for injection in participants with advanced solid tumors.
Detailed description
This is a first-in-human (FIH), Phase I/II, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HY0001a for injection in patients with advanced/metastatic solid tumors. HY0001a for injection is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD) and dose-limiting toxicities（DLT）. In addition, the maximum-tolerated dose and recommended Phase II dose for HY0001a for injection will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test product HY0001a for injection | Experimental | Drug: Test product HY0001a for injectionHY0010a for injection should be administered at the recommended dosage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;
- ≥18 years old and ≤75 years old, gender: male or female;
- Patients have histological or cytological diagnosis with advanced solid tumors, cann't benefit from existing standard treatment options;The solid tumors included in the dose-expansion phase are as follows: Cohort 1: Esophageal cancer (patients who have previously received at least two lines of standard therapy);Cohort 2: Non-small cell lung cancer (patients who have previously received at least two lines of standard therapy);Cohort 3: Other tumors, such as cervical cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, breast cancer, etc. (patients who have failed or are intolerant to standard therapy).
- In the dose-escalation phase, patients must have evaluable tumor lesions; in the dose-expansion phase, patients must have at least one measurable tumor lesion (according to RECIST 1.1 version);
- In the dose-escalation phase, enrollment does not require the expression of CDCP1 (CUB domain containing protein 1). In the dose-expansion phase, enrollment is required to be positive for CDCP1
Key exclusion criteria (22 listed)
- Having received anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks prior to the first administration of the study drug
- Known history of severe allergic reactions, or individuals who have experienced an allergic reaction to any of the excipients in the formulation of HY0001a for injection
- Participants who have previously failed treatment with antibody-drug conjugates (ADCs) that use microtubule inhibitors (Monomethyl auristatin E/Monomethyl auristatin F) as toxins
- Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;
- Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;
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 |
|---|---|---|
| Test product HY0001a for injectionHY0010a for injection should be administered at the recommended dosage | Drug | Test product HY0001a for injection |
Primary outcome
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)
Time frame: 21 days during the first 3-week cycle
Dose-Limiting Toxicity (DLT) will be defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Dose Expansion (Part Two): Objective Response Rate (ORR)
Time frame: Up to 2 years
Proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR)
10 secondary outcomes
Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free monomethyl auristatin E (MMAE, i.e., the toxin) Cmax
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free MMAE (i.e., the toxin) AUC
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY0001a for injection, HY0001a-TAb, and free MMAE (i.e., the toxin) T1/2
Time frame: Up to 2 years
Dose Escalation (Part One): Objective Response Rate (ORR)
Time frame: Up to 2 years
Dose Escalation and Expansion: Duration Of Response (DOR) assessed by investigator per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
Time frame: Up to 2 years
Dose Escalation and Expansion: Disease Control Rate (DCR) assessed by investigator per RECIST Version 1.1
Time frame: Up to 2 years
Dose Escalation and Expansion: Progression-Free Survival (PFS) assessed by investigator per RECIST Version 1.1
Time frame: Up to 2 years
Dose Escalation and Expansion: Overall Survival (OS)
Time frame: Up to 2 years
Immunogenicity assessment indicator: Anti-drug antibodies (ADA)
Time frame: Up to 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 9 Mar 2026.
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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.
Lin Shen study director
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Test product HY0001a for injection in people with Solid Tumor, run by Sichuan Huiyu Pharmaceutical Co., Ltd 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 9 inclusion and 22 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 9 Mar 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lin Shen, Doctor (010-88196340, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT) (time frame: 21 days during the first 3-week cycle). The study lists 3 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 9 Mar 2026.