SafetyPhase 1/2NCT06639256
Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
A Phase 1/2 study testing Test Product HY07121 in people with Safety and Tolerability, run by Sichuan Huiyu Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Safety, Tolerability, Efficacy
- What is being tested?
- Test Product HY07121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 26 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent;
- ≥18 years old and ≤80 years old, gender: male or female;
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;
- Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
- 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
- Within the defined washout periods for prior anti-cancer treatments;
- Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.
- Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.
- Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).
- Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;
- Major surgery within 4 weeks of receiving the first dose of study treatment;
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- Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment;
- Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;
- Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension;
- 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;
- Active known or suspected autoimmune disease.
- History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;
- History of severe allergy;
- History of allogeneic organ transplantation or graft-versus-host disease;
- Have received live/attenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live/attenuated vaccines and mRNA vaccines during the study period;
- Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment;
- Known psychiatric disorder or drug abuse that would interfere the trial requirements;
- Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage;
- In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.);
- Participants considered unsuitable for participation in this study by the investigators.
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
Cancer Hospital of Shandong First Medical University
Jinan
Jinmin Yu, Doctor, +86-521-67626971, sdyujinming@126.com
About this study
Official title: An Open-label, Multiple-center, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.
Read the detailed description
The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2). The main purpose of this study is to evaluate the safety and tolerability of the drug HY07121 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) and preliminary anti-tumor activity. Additional purposes of the study are to evaluate the pharmacokinetics (PK) properties, immunogenicity, correlation of the biomarkers and PK profile with anti-tumor activity.
- Conditions
- Safety, Tolerability, Efficacy
- Being tested
- Test Product HY07121
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product HY07121Drug
Also called HY0007-101
HY07121 should be administered intravenously at recommended dose.
| Study group | Role | What they receive |
|---|---|---|
| Test product HY07121 for Dose Escalation | Experimental | PART ONE- Dose escalation: HY07121 should be administered intravenously at recommended dose. The purpose of the Dose Escalation Phase (Part one) is to characterize the safety and tolerability of the test product HY07121 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) based on the frequency of the occurrence of Dose-Limiting Toxicity (DLT) in each cohort during the DLT evaluation period. Receives: Drug: Test Product HY07121 |
| Test product HY07121 for Dose Expansion | Experimental | PART TWO- Dose expansion: HY07121 should be administered intravenously at recommended dose. Patients will be administered a recommended dose of HY07121 established from the Dose Escalation Phase of the study. Receives: Drug: Test Product HY07121 |
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 or American Society for Transplantation and Cellular Therapy (ASTCT) criteria for Cytokine Release Syndrome (CRS).
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 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Measured: Up to 2 years
Dose Escalation (Part One): Percentage of participants experiencing Adverse Event (AE) related dose interruptions, dose delays, and dose intensity
Occurrence of Adverse Event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure)
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 (13)
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 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Measured: Up to 2 years
Dose Expansion (Part Two): Percentage of participants experiencing adverse event (AE) related dose interruptions, dose delays, and dose intensity
Occurrence of adverse event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure).
Measured: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 Cmax
Maximum concentration observed (Cmax) observed from the pharmacokinetic profile
Measured: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 AUC
Area under the concentration versus time curve calculated using the trapezoidal method
Measured: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 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 and Expansion: Assessment of HY07121 anti-drug-antibody (ADA)
Incidence, duration, titer of serum anti-HY07121 antibody (ADA)
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 HY07121 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: Time-To-Progression (TTP) assessed by investigator per RECIST Version 1.1
Time-To-Progression (TTP) is defined as the time from the date of first administration of HY07121 to the date of the first documented disease progression
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 HY07121 to death due to any cause
Measured: Up to 2 years
Dose Escalation and Expansion: The correlation between tumor biomarkers and efficacy
Objective Response Rate (ORR) is defined as proportion of participants who have a confirmed Complete Response (CR) or a Partial Response (PR) determined by Investigator per RECIST version 1.1. Tumor biomarkers will be tested using Immunohistochemistry (IHC) and scored using Tumor Proportion Score (TPS) and/or Combined Positive Score (CPS) algorithm.
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 posted15 Oct 2024
- Study start24 Oct 2024
- Primary completion26 May 2027 (estimated)
- Study completion26 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiyura666! Yu, Doctor, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639256
- Sponsor's protocol ID
- HY0007-101
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-center, Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06639256
- Acronym / sponsor ID
- HY0007-101
- Conditions
- Safety, Tolerability, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Sichuan Huiyu Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 26 Oct 2027 (estimated)
- First posted
- 15 Oct 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 is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.
Detailed description
The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2). The main purpose of this study is to evaluate the safety and tolerability of the drug HY07121 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) and preliminary anti-tumor activity. Additional purposes of the study are to evaluate the pharmacokinetics (PK) properties, immunogenicity, correlation of the biomarkers and PK profile with anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product HY07121 for Dose Escalation | Experimental | Drug: Test Product HY07121PART ONE- Dose escalation: HY07121 should be administered intravenously at recommended dose. The purpose of the Dose Escalation Phase (Part one) is to characterize the safety and tolerability of the test product HY07121 and determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose(s) (RD) based on the frequency of the occurrence of Dose-Limiting Toxicity (DLT) in each cohort during the DLT evaluation period. |
| Test product HY07121 for Dose Expansion | Experimental | Drug: Test Product HY07121PART TWO- Dose expansion: HY07121 should be administered intravenously at recommended dose. Patients will be administered a recommended dose of HY07121 established from the Dose Escalation Phase of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent;
- ≥18 years old and ≤80 years old, gender: male or female;
- Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;
- Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
Key exclusion criteria (21 listed)
- Within the defined washout periods for prior anti-cancer treatments;
- Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.
- Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.
- Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).
- Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer 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 |
|---|---|---|
| Test Product HY07121Also: HY0007-101HY07121 should be administered intravenously at recommended dose. | Drug | Test product HY07121 for Dose Escalation, Test product HY07121 for Dose Expansion |
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 or American Society for Transplantation and Cellular Therapy (ASTCT) criteria for Cytokine Release Syndrome (CRS).
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 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading
Dose Escalation (Part One): Percentage of participants experiencing Adverse Event (AE) related dose interruptions, dose delays, and dose intensity
Time frame: Up to 2 years
Occurrence of Adverse Event (AE) related dose interruptions, dose delays and dose intensity (duration of HY07121 exposure)
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)
13 secondary outcomes
Dose Expansion (Part Two): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Dose Expansion (Part Two): Percentage of participants experiencing adverse event (AE) related dose interruptions, dose delays, and dose intensity
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 Cmax
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 AUC
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 T1/2
Time frame: Up to 2 years
Dose Escalation and Expansion: Assessment of HY07121 anti-drug-antibody (ADA)
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: Time-To-Progression (TTP) 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
Dose Escalation and Expansion: The correlation between tumor biomarkers and efficacy
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 13 Oct 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.
Huiyura666! Yu, Doctor principal investigator
Shandong Cancer Hospital and 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 HY07121 in people with Safety and Tolerability, 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 8 inclusion and 21 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 Oct 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 Jinmin Yu, Doctor (+86-521-67626971, sdyujinming@126.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 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 13 Oct 2026.