HER2-expressing or -Mutated Unresectable or Metastatic Solid TumorsPhase 2NCT06516926

SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors

A Phase 2 study testing SHR-4602 in people with HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open-label, randomized, multi-center phase II study to evaluate the safety, tolerability, PK, and efficacy of SHR-4602 monotherapy in subjects with HER2-expressing or -mutated unresectable or metastatic solid tumors. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
What is being tested?: SHR-4602
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteChina
Study dates: 8 Aug 2024to 23 May 2025
Phase: Phase 2
Are there results?: None posted in the registry

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

Aged 18-75 years (inclusive);
ECOG PS of 0 or 1;
Subjects are willing to provide tumor tissue samples for immunohistochemistry, ISH, or genetic testing to confirm HER2 expression or mutation; the sponsor on the enrollment;
Have at least one measurable lesion according to RECIST v1.1;
Expected survival ≥ 3 months;
Major organ functions meet the following criteria ；

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Female subjects of childbearing potential must agree to take contraceptive measures, and use acceptable contraceptive measures with their partners from the signing of the ICF to 8 months after the last dose (see 13.1.2 for details); female subjects must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating, and agree to avoid egg donation during the treatment period until 8 months after the last dose of the investigational drug;
Male subjects with female partners of childbearing potential must agree to use acceptable contraceptive measures during the treatment period until 8 months after the last dose of the investigational drug (see 13.1.2 for details), and agree not to donate sperm during this period. Male subjects whose partner has become pregnant must use condoms, and no other contraceptive methods are required;
Voluntarily participate in this clinical study, be willing and able to comply with procedures related to clinical visits and study, and understand and have signed the informed consent.

Who cannot join

Active brain metastases, carcinomatous meningitis, or primary central nervous system (CNS) tumors that have not been treated with surgery or radiotherapy; s
subjects with peripheral neuropathy (those with mild symptoms that do not require treatment and not affect the study results or increase the risk may be included as judged by the investigator);
Have received surgery (major surgery for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose (palliative radiotherapy within 2 weeks prior to the first dose);
Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;
Subjects with toxicities and/or complications from prior treatment that have not recovered to NCI-CTCAE Grade ≤ 1 may be enrolled if the investigator judges that these conditions are of NCI-CTCAE Grade ≤ 2 and no safety risk to the subjects;

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Have the following lung diseases or medical history: (1) known or suspected interstitial lung disease; (2) moderate to severe lung diseases that seriously affect lung function within the past 3 months, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia/obliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), and obstructive/restrictive lung disease, which may interfere with the testing or management of treatment-related pulmonary toxicities; (3) any autoimmune, connective tissue, or inflammatory disease involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, and sarcoidosis; (4) prior pneumonectomy; (5) Grade ≥ 3 interstitial lung disease during prior treatment with immune checkpoint inhibitors. Subjects with interstitial lung changes may be enrolled if there is no safety risk as judged by the investigator;
Have had pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose;
Have active autoimmune disease, disease requiring treatment with systemic steroids or immunosuppressive drugs, other acquired (HIV infection) or congenital immunodeficiency, or history of organ transplantation (including allogeneic bone marrow transplantation);
Have poorly controlled or severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) acute coronary syndrome, congestive heart failure (New York Heart Association [NYHA] Cardiac Function Class ≥ II), or aortic dissection within 6 months prior to the first dose of the investigational product; (2) new-onset severe/unstable angina within the past 2 months; (3) myocardial ischemia requiring long-term medication and NYHA Class ≥ II cardiac insufficiency; (4) acute myocardial infarction within 6 months before screening; (5) supraventricular arrhythmia or ventricular arrhythmia requiring treatment or interventions; (6) cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, or stroke) and pulmonary embolism within 6 months prior to the first dose of the investigational drug;
Known hereditary or acquired hemorrhage and thrombophilia (such as hemophilia and coagulopathy);
Have untreated active hepatitis (active hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] positive and HBV-DNA ≥ 500 IU/mL; active hepatitis C, defined as hepatitis C virus antibody [HCV-Ab] positive and HCV-RNA above the lower limit of detection);
Have experienced severe infection within 30 days prior to the first dose, including but not limited to infection complications, bacteremia, and severe pneumonia requiring hospitalization; have experienced active infection treated with therapeutic intravenous antibiotics within 2 weeks prior to the first dose. subjects who have received prophylactic antibiotic therapy (e.g., for prevention of urinary tract infection) can be enrolled;
Other malignancies within the past 5 years or currently, except for cured cervical carcinoma in situ and basal or squamous cell carcinoma of skin;
Known to be allergic to any component or excipient of the SHR-4602 product, or have a history of severe anaphylaxis to other monoclonal antibody/fusion protein drugs; Have other severe physical or psychiatric disorders or laboratory abnormalities, which may increase the risk of participating in this study or interfere with the study results, as well as other conditions that make subjects unsuitable for participating in this study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: An Open-label, Randomized, Multi-center Phase II Clinical Study of SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors

During the study, a safety monitoring committee (SMC), consisting of the principal investigator, sponsor representative, etc., will be established to review data from the study regarding safety, PK, efficacy, etc. The SMC will make decisions on study-related issues.

The study includes a screening period (begins when the informed consent form (ICF) is signed and ends at the first dose), a treatment period (from the first dose to the last dose), and a follow-up period (end-of-treatment safety follow-up).

Conditions: HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
Being tested: SHR-4602

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SHR-4602Drug
Intravenous infusion, cycle every 21 days;

Study groups in NCT06516926
Study group	Role	What they receive
Dose 1	Experimental	Not described Receives: Drug: SHR-4602
Dose 2	Experimental	Not described Receives: Drug: SHR-4602
Dose 3	Experimental	Not described Receives: Drug: SHR-4602

What is being measured

The primary outcome is the main question the study is designed to answer.

Two years objective response rate (ORR);
Measured: Two years

Secondary outcomes (9)

Duration of response (dor)
Measured: Two years
Progression-free survival (PFS)
Measured: Two years
Best overall response (BOR)
Measured: Two years
Disease control rate (DCR)
Measured: Two years
Incidence and severity of adverse events (aes)
Measured: Two years
Severe adverse events (saes) (graded as per CTCAE v5.0)
Measured: Two years
Blood concentrations of conjugated antibodies
Measured: Two years
Blood concentrations of total antibodies
Measured: Two years
Blood concentrations of free toxin.
Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 202423 May 2025

First posted24 Jul 2024
Study start8 Aug 2024
Primary completion23 May 2025
Study completion23 May 2025

Why it stopped: The adjustment of the sponsor's R\&D strategy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HER2-expressing or -Mutated Unresectable or Metastatic Solid TumorsStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06516926
Sponsor's protocol ID: SHR-4602-201
Status last verified: Aug 2026
First submitted: 18 Jul 2024
Last updated: 6 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Multi-center Phase II Clinical Study of SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06516926
Acronym / sponsor ID: SHR-4602-201
Conditions: HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The adjustment of the sponsor's R\&D strategy.
Enrolment: 11 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Aug 2024 (actual)
Primary completion: 23 May 2025 (actual)
Study completion: 23 May 2025 (actual)
First posted: 24 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dose 1	Experimental	Drug: SHR-4602
Dose 2	Experimental	Drug: SHR-4602
Dose 3	Experimental	Drug: SHR-4602

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Aged 18-75 years (inclusive);
ECOG PS of 0 or 1;
Subjects are willing to provide tumor tissue samples for immunohistochemistry, ISH, or genetic testing to confirm HER2 expression or mutation; the sponsor on the enrollment;
Have at least one measurable lesion according to RECIST v1.1;
Expected survival ≥ 3 months;

Key exclusion criteria (15 listed)

Active brain metastases, carcinomatous meningitis, or primary central nervous system (CNS) tumors that have not been treated with surgery or radiotherapy; s
subjects with peripheral neuropathy (those with mild symptoms that do not require treatment and not affect the study results or increase the risk may be included as judged by the investigator);
Have received surgery (major surgery for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose (palliative radiotherapy within 2 weeks prior to the first dose);
Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;

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-4602Intravenous infusion, cycle every 21 days;	Drug	Dose 1, Dose 2, Dose 3

Primary outcome

Two years objective response rate (ORR);
Time frame: Two years

9 secondary outcomes

Duration of response (dor)
Time frame: Two years
Progression-free survival (PFS)
Time frame: Two years
Best overall response (BOR)
Time frame: Two years
Disease control rate (DCR)
Time frame: Two years
Incidence and severity of adverse events (aes)
Time frame: Two years
Severe adverse events (saes) (graded as per CTCAE v5.0)
Time frame: Two years
Blood concentrations of conjugated antibodies
Time frame: Two years
Blood concentrations of total antibodies
Time frame: Two years
Blood concentrations of free toxin.
Time frame: Two years

Results and safety

The study was stopped early (reason given: The adjustment of the sponsor's R\&D strategy.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
Individual participant dataSharing planned: Undecided

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-4602 in people with HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors, run by Jiangsu HengRui Medicine 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 15 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: stopped early, as of the sponsor's last update on 6 Aug 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 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?

The study was stopped early (reason given: The adjustment of the sponsor's R\&D strategy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two years objective response rate (ORR); (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06516926.

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 6 Aug 2026.