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Advanced Solid TumorsPhase 1NCT06094556

An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors

A Phase 1 study testing SHR-1826 in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SHR-1826
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
25 Dec 2023to 31 Jul 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

  • Able and willing to provide a written informed consent.
  • 18-75 years old ，Male or female.
  • ECOG score is 0 or 1.
  • Subjects with advanced or metastatic solid tumors that have been documented by histopathology and are not responding to or tolerated by standard treatment, or have no effective standard treatment options.
  • Have at least one measurable lesion according to RECIST v1.1 criteria.
  • Expected survival ≥3 months .
  • With good vital organ function.
  • Contraception.

Who cannot join

  • With untreated or active Central nervous system (CNS) tumor metastasis. Subjects with a history or current history of meningeal metastasis.
  • Previous or co-existing malignant tumors.
  • Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
  • Patients with uncontrolled tumor-related pain.
  • Received systemic antitumor therapy 4 weeks before starting study treatment; Previously receiving small molecule targeted therapy, the interval of not less than 5 half-lives of the drug can be enrolled.
  • Previously received antibody-coupled drug therapy.
Show all 21Show fewer
  • Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing.
  • First study subjects receiving >30Gy non-radical chest radiation within 28 days prior to administration, >30Gy chest radiation within 24 weeks prior to first administration, and ≤30Gy palliative radiation within 14 days prior to first administration;If previously received radioisotope therapy, the interval of not less than 5 half-lives of the isotope drug can be included.
  • Is participating in another clinical study or the time of first administration is less than 4 weeks from the end of the previous clinical study (last administration), or the 5 half-life of the investigational drug, whichever is the older.
  • The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1.
  • Other severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity within the first three months of administration that significantly affect respiratory function; Any autoimmune, connective tissue, or inflammatory disease with lung involvement; Prior left or right total lung resection.
  • Pleural effusion, ascites, or pericardial effusion requiring intervention occurred within 2 weeks prior to the first dose.
  • Have an active autoimmune disease, or other acquired (HIV infection), congenital immunodeficiency disease, or a history of organ transplantation.
  • Have poorly controlled or severe cardiovascular disease.
  • Known hereditary or acquired bleeding and thrombotic tendencies, and clinically significant bleeding symptoms and arterial/venous thrombosis events in the 3 months prior to the first dose.
  • Untreated active hepatitis.
  • Subjects who had a severe infection within 30 days prior to the first dose; Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment were found by medical history or CT examination, or had a history of active pulmonary tuberculosis infection more than 1 year ago but had not received regular treatment.
  • Live attenuated vaccine should be administered within 30 days prior to the first dose.
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Known allergy to any component or excipient of the SHR-1826 product.
  • The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study, or interfere with the study results, as well as conditions that the investigator deems inappropriate to participate in the study.

Trial locations and contacts

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

Yijun Jia contact

+0518-81220121

yijun.jia@hengrui.com

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Ruihua Xu, Doctor, +86-020-87343468, ruihxu@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open Phase I Clinical Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-1826 for Injection in Patients With Advanced Solid Tumors

This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. The whole study was divided into three stages: dose increment, dose extension and therapeutic effect extension.

Being tested
SHR-1826

What participants receive

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

  • SHR-1826Drug

    dose is calculated based on the subjects' baseline weight.

Study groups in NCT06094556
Study groupRoleWhat they receive
SHR-1826ExperimentalDose escalation; Dose expansion; Therapeutic effect expansion.
Receives: Drug: SHR-1826

What is being measured

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

  1. Dose-limiting toxicity

    evaluate the safety in the doses escalation

    Measured: 21 Days

  2. Maximum tolerated dose or Maximum-administered dose

    evaluate the safety in the doses escalation

    Measured: Approximately 1 year

  3. Recommended Phase 2 dose (RP2D)

    evaluate the safety and curative effect in the doses escalation

    Measured: Approximately 2 years

Secondary outcomes (14)

  1. Maximum concentration (Cmax) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  2. Time to maximum concentration (Tmax) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  3. Areas under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  4. Areas under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  5. Half-life (t1/2) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  6. Mean retention times (MRT) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  7. Clearance rate (CL) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  8. Volume of distribution at the steady state (Vss) of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  9. Anti-drug antibody of SHR-1826

    To evaluate the pharmacokinetic characteristics of SHR-1826

    Measured: Approximately 2 years

  10. Objective response rate (ORR)

    Preliminary evaluation of the effectiveness of SHR-1826

    Measured: Approximately 2 years

  11. Duration of response (DoR)

    Preliminary evaluation of the effectiveness of SHR-1826

    Measured: Approximately 2 years

  12. Disease control rate (DCR)

    Preliminary evaluation of the effectiveness of SHR-1826

    Measured: Approximately 2 years

  13. Progression free survival (PFS)

    Preliminary evaluation of the effectiveness of SHR-1826

    Measured: Approximately 2 years

  14. Overall survival (OS)

    Preliminary evaluation of the effectiveness of SHR-1826

    Measured: Approximately 2 years

Timeline

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

  1. First posted23 Oct 2023
  2. Study start25 Dec 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 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
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06094556
Sponsor's protocol ID
SHR-1826-I-101
Status last verified
Apr 2025
First submitted
16 Oct 2023
Last updated
13 Apr 2025
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-1826 in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals 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 8 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 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?

Contact Yijun Jia (+0518-81220121, yijun.jia@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: 21 Days). The study lists 3 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 NCT06094556.

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 13 Apr 2025.

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