Solid TumorsPhase 1/2NCT06955390
Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SHR-A2102+HRS-4642 in people with Solid Tumors, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- SHR-A2102+HRS-4642
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 1 Dec 2026
- 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
- Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
- The age of signing the informed consent is from 18 to 75 years old, regardless of gender
- Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
- The ECOG score is 0 or 1
- Expected survival ≥12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Good level of organ function
- Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods
Who cannot join
- subjects with uncontrolled or active brain metastasis；
- subjects with clinical significant lung disease;
- subjects with history of autoimmune diseases;
- Known active hepatitis B or C infection;
- Subjects with severe cardiovascular and cerebrovascular diseases
- Uncontrolled tumor-related pain
Show all 11Show fewer
- Severe infections that require intravenous antibiotic, antiviral or antifungal control
- Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
- Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- Known allergic to any compound of SHR-A2102 or HRS-4642
- Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhen He, Professor contact
China1 site
Henan Cancer Hospital
Zhengzhou, Henan
Zhen He, Professor, 13523530961, hezhenriver@126.com
About this study
Official title: An Exploratory Clinical Study of HRS-4642 in Combination With SHR-A2102 for the Treatment of Advanced Solid Tumors
The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors
Read the detailed description
This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.
- Conditions
- Solid Tumors
- Being tested
- SHR-A2102+HRS-4642
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A2102+HRS-4642Drug
A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | SHR-A2102+HRS-4642 Receives: Drug: SHR-A2102+HRS-4642 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity(DLT)
one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.
Measured: At the end of Cycle 1 (each cycle is 14 days)
Objective Response Rate (ORR)
the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 1 year
Secondary outcomes (5)
Progression-free Survival (PFS)
the time from treatment initiation to the first disease progression or death from any cause
Measured: up to 2 year
Overall survival(OS)
the time from treatment initiation until death from any reason
Measured: up to 2 year
Disease Control Rate (DCR)
the proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
Measured: up to 1 year
Duration of response (DoR)
Assessed by Investigator According to RECIST v1.1
Measured: up to 1 year
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory
Assess safety and tolerability by way of adverse events (CTCAE v5.0)
Measured: Begin from sign the ICF until the end of the safety follow-up period，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 May 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qiming Wang, Professor, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955390
- Sponsor's protocol ID
- ST-HRS4642-SHRA2102
- Status last verified
- Oct 2024
- First submitted
- 20 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of HRS-4642 in Combination With SHR-A2102 for the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06955390
- Acronym / sponsor ID
- ST-HRS4642-SHRA2102
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 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.
The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors
Detailed description
This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-A2102+HRS-4642SHR-A2102+HRS-4642 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
- The age of signing the informed consent is from 18 to 75 years old, regardless of gender
- Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
- The ECOG score is 0 or 1
- Expected survival ≥12 weeks
Key exclusion criteria (11 listed)
- subjects with uncontrolled or active brain metastasis；
- subjects with clinical significant lung disease;
- subjects with history of autoimmune diseases;
- Known active hepatitis B or C infection;
- Subjects with severe cardiovascular and cerebrovascular 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 |
|---|---|---|
| SHR-A2102+HRS-4642A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted. | Drug | Treatment group |
Primary outcome
Dose Limited Toxicity(DLT)
Time frame: At the end of Cycle 1 (each cycle is 14 days)
one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle.
Objective Response Rate (ORR)
Time frame: up to 1 year
the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5 secondary outcomes
Progression-free Survival (PFS)
Time frame: up to 2 year
Overall survival(OS)
Time frame: up to 2 year
Disease Control Rate (DCR)
Time frame: up to 1 year
Duration of response (DoR)
Time frame: up to 1 year
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory
Time frame: Begin from sign the ICF until the end of the safety follow-up period，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 May 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Zhen He, Professor contact
Qiming Wang, Professor principal investigator
Henan Cancer Hospital
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 SHR-A2102+HRS-4642 in people with Solid Tumors, run by Henan Cancer Hospital 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 11 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: opening soon, as of the sponsor's last update on 2 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 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 Qiming Wang, Professor (+8613783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity(DLT) (time frame: At the end of Cycle 1 (each cycle is 14 days)). The study lists 2 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 2 May 2025.