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Malignant TumoursPhase 1NCT04414150

A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours

A Phase 1 study testing SHR-1802 in people with Malignant Tumours, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Tumours
What is being tested?
SHR-1802
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
17 Jun 2020to 15 Mar 2022
Phase
Phase 1
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

  • Voluntary participation and written informed consent;
  • Aged 18-75 years (inclusive), males and females;
  • Patient must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
  • At least one measurable lesion according to RECIST v1.1;
  • ECOG score of 0-1;
  • Expected survival ≥ 12 weeks;
  • Adequate bone marrow reserve and organ function were confirmed by baseline examination
  • For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;

Who cannot join

  • The presence of any active, known, or suspected autoimmune disease. Type 1 diabetes, which was admitted to receive stable dose of insulin, hypothyroidism, which required only hormone replacement therapy, skin disease with no need to systemic treatment and no acute exacerbation within 1 year before the screening period;
  • Subjects who had received systemic treatment with corticosteroids or other immunosuppressive agents within 28 days prior to initial administration.
  • Known and untreated central nervous system (CNS) or leptomeningeal metastases;
  • Uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures;
  • Uncontrolled cardiac diseases or symptoms;
  • Known hereditary or acquired bleeding and thrombotic tendencies;
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  • Patients who have previously received chemotherapy, radiotherapy or surgery which ended within 4 weeks prior to the start of this study; oral molecular targeted therapy with < 5 drug half-lives from the first study dose; or patients with AEs caused by previous treatment (except for alopecia) that have not returned to CTCAE Grade ≤ 1;
  • Known active infection,;
  • Congenital and acquired immune deficiency;
  • HBsAg-positive and HBV DNA > 2000 IU/mL(or 104 copies/mL); HCV RNA copies > ULN;
  • Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: Tolerability, Safety and Pharmacokinetic Characteristics of SHR-1802 in Patients With Advanced Malignancy: a Phase I Clinical Study

This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.

Being tested
SHR-1802
Medical subject headings
Neoplasms

What participants receive

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

  • SHR-1802Drug

    This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.

Study groups in NCT04414150
Study groupRoleWhat they receive
SHR-1802ExperimentalNot described
Receives: Drug: SHR-1802

What is being measured

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

  1. Dose limiting toxicity

    Measured: Days 1-21

Secondary outcomes (13)

  1. Percentage of patients with adverse events

    Measured: from the first drug administration to within 90 days for the last SHR-1802 dose

  2. Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events

    Measured: At pre-defined intervals from initial dose up to 24 months

  3. ORR

    Measured: At pre-defined intervals from initial dose up to 24 months

  4. DOR

    Measured: At pre-defined intervals from initial dose up to 24 months

  5. DCR

    Measured: At pre-defined intervals from initial dose up to 24 months

  6. PFS

    Measured: At pre-defined intervals from initial dose up to 24 months

  7. Maximum Concentration (Cmax) of SHR-1802

    Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)

  8. Time of Maximum Concentration (Tmax) of SHR-1802

    Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)

  9. Area Under the Curve (AUC) of SHR-1802

    Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)

  10. Terminal Half-Life (T1/2) of SHR-1802

    Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)

  11. Clearance (CL) of SHR-1802

    Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)

  12. Volume of Distribution at Steady State (Vss) of SHR-1802

    Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)

  13. Evaluation of the immunogenicity of SHR-1802

    Serum sampling to assess the potential for anti-drug antibody (ADA) formation.

    Measured: At pre-defined intervals from initial dose through final study visit (up to 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 posted4 Jun 2020
  2. Study start17 Jun 2020
  3. Primary completion13 Jan 2022
  4. Study completion15 Mar 2022

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414150
Sponsor's protocol ID
SHR-1802-I-101
Status last verified
Jun 2022
First submitted
25 May 2020
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Deng T, Liu Z, Han Z, Zhou H, Liu R, Li Y, Li S, Xiu P, Wang S, Zhang Y, Ba Y. Safety, tolerability, and pharmacokinetics of an anti-LAG-3 antibody SHR-1802 in patients with advanced solid tumors: a phase I dose-escalation and dose-expansion study. Ther Adv Med Oncol. 2023 Jul 29;15:17588359231186025. doi: 10.1177/17588359231186025. eCollection 2023.

    PubMed 37529157

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR-1802 in people with Malignant Tumours, 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 26 Oct 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 limiting toxicity (time frame: Days 1-21). 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 NCT04414150, which also lists 1 linked publication.

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 Oct 2022.

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