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Active, not recruitingNCT06993116Updated Jan 28, 2026

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

A Phase 1 interventional study of SHR-4712 Injection in Advanced Solid Tumor, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-28.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. The subject has a history of or currently has meningeal metastases, or has symptomatic and active central nervous system metastases.
  2. The subject has spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
  3. The subject has uncontrollable tumor-related pain as judged by the investigator.
  4. The subject has clinically symptomatic moderate or severe ascites, uncontrollable pleural effusion or pericardial effusion of moderate amount or more.
  5. The subject has received systemic immunosuppressive treatment within 14 days before the first study drug administration.
  6. The subject has active autoimmune diseases or a history of autoimmune diseases with a possibility of recurrence.
  7. The subject has severe cardiovascular and cerebrovascular diseases.
  8. The subject has other uncontrolled concomitant diseases before the first drug administration.
  9. The subject has a history of severe allergic reactions to the test drug and its main formulation components.
  10. The subject has a history of immunodeficiency, including positive HIV serological test results, and other acquired or congenital immunodeficiency diseases.
  11. The subject has had a severe infection within 4 weeks before the first drug administration.
  12. 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.
  13. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    SHR-4712 Group

    Drug: SHR-4712 Injection

Interventions

  • DrugSHR-4712 Injection

    SHR-4712 injection.

06

What researchers measure

Primary outcomes

  1. Dose Limited Toxicity (DLT)

    Time frame: First 21 days of treatment.

  2. Adverse Events (AEs)

    Time frame: Approximately 24 months.

Secondary outcomes

  1. Time to peak concentration (Tmax)

    Time frame: Approximately 24 months.

  2. Peak concentration (Cmax)

    Time frame: Approximately 24 months.

  3. Trough concentration (Ctrough)

    Time frame: Approximately 24 months.

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

    Time frame: Approximately 24 months.

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

    Time frame: Approximately 24 months.

  6. Elimination half-life (t1/2)

    Time frame: Approximately 24 months.

  7. Apparent clearance (CL/F)

    Time frame: Approximately 24 months.

  8. Apparent volume of distribution (Vz/F)

    Time frame: Approximately 24 months.

  9. Objective response rate (ORR)

    Time frame: Approximately 24 months.

  10. Duration of objective tumor response (DoR)

    Time frame: Approximately 24 months.

  11. Disease control rate (DCR)

    Time frame: Approximately 24 months.

  12. Progression-free survival (PFS)

    Time frame: Approximately 24 months.

  13. Overall survival (OS)

    Time frame: Approximately 24 months.

07

Study locations

2 sites
  • Fujian Cancer Hospital
    Fuzhou, Fujian 350014, China
  • Hunan Cancer Hospital
    Changsha, Hunan 410013, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06993116
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 28, 2025
Start date
Jun 9, 2025
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Jan 28, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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