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Advanced Solid TumorsPhase 2NCT06704828

A Phase II Study of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Advanced Solid Tumors

A Phase 2 study testing SHR-4602 in people with Advanced Solid Tumors, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SHR-4602
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Dec 2024to Apr 2027
Phase
Phase 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

  • 18-80 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment;
  • Provide archived or fresh tumor tissue；HER2 expression is required for subjects in Stage I;
  • At least one measurable lesion according to RECIST v1.1；
  • Expected survival ≥12 weeks
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  • Good level of organ function；
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating. Male subjects whose partners are women of childbearing age and female subjects who are fertile must agree to avoid sperm or egg donation during the treatment period until 8 months after the last dose of the investigational drug;
  • 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；

Who cannot join

  • Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
  • Subjects with peripheral neuropathy；
  • Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment;
  • Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;
  • Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment;
  • Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;
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  • Toxicity and/or complications of previous antitumor therapy has not resolved to NCI-CTCAE level ≤1 or exclusion criteria；
  • 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; (3) any autoimmune, connective tissue, or inflammatory disease involving the lungs; (4) prior pneumonectomy; (5) Grade ≥ 3 interstitial lung disease during prior treatment with immune checkpoint inhibitors.
  • Stage 2: ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；
  • Have any active, known or suspected autoimmune diseases;
  • Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；
  • The presence of clinical cardiac symptoms or diseases that are not well controlled；
  • Known hereditary or acquired hemorrhage and thrombophilia；
  • Have untreated active hepatitis；
  • Subjects who had a severe infection within 30 days prior to the first dose；
  • Any other malignancy diagnosed within the previous 5 years；
  • Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；
  • History of immune deficiency；
  • Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；
  • Known severe allergic reactions to any component of SHR-4602, or other monoclonal antibody/fusion protein drugs；
  • Female subjects who are pregnant or plan to become pregnant during the study period；
  • The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；
  • In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fan Liang contact

+86 13761090346

fan.liang@hengrui.com

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Jun Guo

Other trials in China

About this study

Official title: An Open-label, Multi-center Phase II Study to Evaluate the Safety, Tolerablity, Pharmacokinetics, and Efficacy of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Sujbects With Advanced Solid Tumors

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced 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

    SHR-4602

Study groups in NCT06704828
Study groupRoleWhat they receive
SHR-4602ExperimentalNot described
Receives: Drug: SHR-4602

What is being measured

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

  1. ORR by investigator assessment

    ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years;

    Measured: Up to approximately 5 years;

Secondary outcomes (5)

  1. DCR by investigator assessment,

    DCR by investigator assessment was defined as the percentage of participants with confirmed response (CR or PR), or SD, per RECIST v1.1 per investigator, Up to approximately 5 years;

    Measured: Up to approximately 5 years;

  2. DoR by investigator assessment,

    DoR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first, Up to approximately 5 years;

    Measured: Up to approximately 5 year

  3. PFS by investigator assessment,

    PFS was defined as the time from date of start of study treatment to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first, Up to approximately 5 years;

    Measured: Up to approximately 5 years;

  4. OS

    OS is defined as the time from start of study treatment to death from any cause, Up to approximately 5 years;

    Measured: Up to approximately 5 years;

  5. Number of participants with adverse events (AEs),

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship, Up to approximately 5 years;

    Measured: Up to approximately 5 years;

Timeline

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

  1. First posted26 Nov 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06704828
Sponsor's protocol ID
SHR-4602-202
Status last verified
Nov 2024
First submitted
22 Nov 2024
Last updated
26 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-4602 in people with Advanced Solid Tumors, run by Shanghai Hengrui 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 23 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 26 Nov 2024. 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?

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 Fan Liang (+86 13761090346, fan.liang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR by investigator assessment (time frame: Up to approximately 5 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 NCT06704828.

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 26 Nov 2024.

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