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Advanced Solid TumorPhase 1NCT06993116

A Phase I Study of SHR-4712 in Patients With Advanced Solid Tumors

A Phase 1 study testing SHR-4712 Injection in people with Advanced Solid Tumor, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 1, open label, first-in-human study to evaluate safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and anti-tumor activity of SHR-4712 in patients with advanced solid tumors. Patients will treat with SHR-4712 until unacceptable toxicity or disease progression. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SHR-4712 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesChina
Study dates
9 Jun 2025to May 2027
Phase
Phase 1
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

  • The subject voluntarily participates in this study and signs the informed consent form.
  • The subject is aged between 18 and 75 years old (inclusive), regardless of gender.
  • The subject must provide tumor tissue samples for biomarker testing.
  • The subject's ECOG performance status is 0 or 1.
  • The expected survival time is ≥ 12 weeks.
  • The subject has at least one measurable lesion that meets the requirements of RECIST v1.1.
  • Laboratory test results confirm that the subject has sufficient functions of vital organs.
  • Female subjects of child-bearing potential must not be breastfeeding, have no possibility of pregnancy, and agree to comply with relevant contraceptive requirements.

Who cannot join

  • The subject has a history of or currently has meningeal metastases, or has symptomatic and active central nervous system metastases.
  • The subject has spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
  • The subject has uncontrollable tumor-related pain as judged by the investigator.
  • The subject has clinically symptomatic moderate or severe ascites, uncontrollable pleural effusion or pericardial effusion of moderate amount or more.
  • The subject has received systemic immunosuppressive treatment within 14 days before the first study drug administration.
  • The subject has active autoimmune diseases or a history of autoimmune diseases with a possibility of recurrence.
Show all 13Show fewer
  • The subject has severe cardiovascular and cerebrovascular diseases.
  • The subject has other uncontrolled concomitant diseases before the first drug administration.
  • The subject has a history of severe allergic reactions to the test drug and its main formulation components.
  • The subject has a history of immunodeficiency, including positive HIV serological test results, and other acquired or congenital immunodeficiency diseases.
  • The subject has had a severe infection within 4 weeks before the first drug administration.
  • The subject has a history of active pulmonary tuberculosis infection within 1 year before enrollment as found through medical history or CT examination, or has a history of active pulmonary tuberculosis infection more than 1 year ago but has not received regular treatment.
  • The subject has other serious physical or mental diseases, known alcohol or drug dependence, abnormal laboratory test results, and other factors that may increase the risk of participating in the study or interfere with the study results, and any other situations that the investigator deems unsuitable for participation in this study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

Other trials in China

About this study

Official title: A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4712 in Patients With Advanced Solid Tumors

This is a Phase 1, open label, first-in-human study to evaluate safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and anti-tumor activity of SHR-4712 in patients with advanced solid tumors. Patients will treat with SHR-4712 until unacceptable toxicity or disease progression.

Being tested
SHR-4712 Injection

What participants receive

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

  • SHR-4712 InjectionDrug

    SHR-4712 injection.

Study groups in NCT06993116
Study groupRoleWhat they receive
SHR-4712 GroupExperimentalNot described
Receives: Drug: SHR-4712 Injection

What is being measured

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

  1. Dose Limited Toxicity (DLT)

    Measured: First 21 days of treatment.

  2. Adverse Events (AEs)

    Measured: Approximately 24 months.

Secondary outcomes (13)

  1. Time to peak concentration (Tmax)

    Measured: Approximately 24 months.

  2. Peak concentration (Cmax)

    Measured: Approximately 24 months.

  3. Trough concentration (Ctrough)

    Measured: Approximately 24 months.

  4. Area under the concentration-time curve from time zero to the last measurable time point (AUC0-t)

    Measured: Approximately 24 months.

  5. Area under the concentration-time curve from time zero to infinity (AUC0-∞)

    Measured: Approximately 24 months.

  6. Elimination half-life (t1/2)

    Measured: Approximately 24 months.

  7. Apparent clearance (CL/F)

    Measured: Approximately 24 months.

  8. Apparent volume of distribution (Vz/F)

    Measured: Approximately 24 months.

  9. Objective response rate (ORR)

    Measured: Approximately 24 months.

  10. Duration of objective tumor response (DoR)

    Measured: Approximately 24 months.

  11. Disease control rate (DCR)

    Measured: Approximately 24 months.

  12. Progression-free survival (PFS)

    Measured: Approximately 24 months.

  13. Overall survival (OS)

    Measured: Approximately 24 months.

Timeline

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

  1. First posted28 May 2025
  2. Study start9 Jun 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06993116
Sponsor's protocol ID
SHR-4712-101
Status last verified
Jan 2026
First submitted
19 May 2025
Last updated
28 Jan 2026
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 1 study testing SHR-4712 Injection in people with Advanced Solid Tumor, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 2 sites 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 13 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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.

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?

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?

Dose Limited Toxicity (DLT) (time frame: First 21 days of treatment.). 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?

On the ClinicalTrials.gov record for NCT06993116.

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 28 Jan 2026.

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