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Advanced MalignanciesPhase 1NCT03995472

A Study of SHR-1501 Combined With SHR-1316 in Patients With Advanced Tumors

A Phase 1 study testing SHR-1501 and SHR-1316 in people with Advanced Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 5 sites in 2 countries.

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

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignancies
What is being tested?
SHR-1501 and SHR-1316
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
5 sitesin 2 countries
Study dates
14 Feb 2020to 12 Jan 2023
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

  • All Patients All patients must meet all the following criteria to be eligible to participate:
  • Voluntarily participate in this clinical study, understand the research procedure and be able to sign informed consent in writing;
  • Subjects must be willing and able to follow the research protocol;
  • Aged 18-75 years old when the informed consent form is signed;
  • Have a histologically or cytologically confirmed diagnosis of advanced or metastatic tumor malignancy;
  • Patients' malignancies must be relapsed or refractory to standard treatment, or patients cannot tolerate standard treatment, or patients have actively refused standard therapy;
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  • FFPE tumor tissue or unstained slides of tumor sample must be obtained from patients enrolled in the dose expansion or indication expansion stage, both preserved samples collected within 6 months before the first dose (or up to 12 months prior to the first dose) and fresh samples (preferred) are acceptable;
  • Eastern Cooperative Oncology Group ECOG PS score of 0-1;
  • Have a life expectancy of ≥ 12 weeks;
  • Adequate organ function defined according to the protocol, These results should be completed within 14 days prior to the first study treatment:
  • Non-surgically sterilized women of childbearing age or male subjects are required to consent to the use of at least one medically approved contraceptive (eg intrauterine devices, contraceptives or condoms) is performed during the study treatment period and within 3 months of the end of the study treatment period.

Who cannot join

  • Patients with cancerous meningitis (ie meningeal metastasis);
  • Patients with active central nervous system (CNS) metastasis.
  • Spinal cord compression that cannot be radically treated with surgery and/or radiotherapy cannot be enrolled.
  • Patients with double cancer or more serious cancer;
  • Patients with a history of autoimmune diseases;
  • Significant clinical significance in the history of cardiovascular disease;
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  • Arterial/venous thrombosis events such as cerebrovascular accidents deep vein thrombosis and pulmonary embolism within 6 months prior to first administration;
  • Have a history of immunodeficiency including HIV infection;
  • Active hepatitis B or hepatitis C patients;
  • Any disease or symptom that is not appropriate for inclusion in this study determined by the investigator.;
  • Patients have undergone major surgery within 28 days prior to the first dose (except for diagnostics);
  • Those who used a live attenuated vaccine within 4 weeks prior to the first dose or expect a live attenuated vaccine during the study period;
  • Those who received other clinical trials within 4 weeks prior to the first study;
  • Those who received systemic immunosuppressive therapy within 2 weeks prior to the first study dose;
  • Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
  • A history of severe allergic reactions to other monoclonal antibody/fusion protein drugs;
  • Mental illness, alcohol abuse, drug abuse or substance abuse;
  • Any disease or condition that causes reasonable suspicion to prohibit the use of the study drug or affect the interpretation of the study results or the patient is at high risk of treatment complications (any other disease, metabolic disorder, physical examination results or laboratory tests abnormalities);
  • Pregnant or lactating women or women planning to become pregnant during the study.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Australia4 sites

  • Sydney Southwest Private Hospital

    Liverpool, New South Wales, 2170

  • Scientia Clinical Research

    Randwick, New South Wales, 2031

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101

  • John Flynn Private Hospital

    Tugun, Queensland, 4224

Other trials in Australia

China1 site

  • Guangdong General Hospital & Guangdong Academy of Medical Sciences

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination With SHR-1316 in Patients With Advanced Malignancies

The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies.

Being tested
SHR-1501, SHR-1316

What participants receive

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

  • SHR-1501Drug

    Administered subcutaneously

  • SHR-1316Drug

    Administered intravenously

Study groups in NCT03995472
Study groupRoleWhat they receive
SHR-1501 and SHR-1316 dose escalationExperimentalSHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.
Receives: Drug: SHR-1501; Drug: SHR-1316
SHR-1501 and SHR-1316 dose expansionExperimentalSHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.
Receives: Drug: SHR-1501; Drug: SHR-1316
SHR-1501 and SHR-1316 Indication expansionExperimentalSHR-1501 given subcutaneously with a recommended dose. SHR-1316 given intravenously.
Receives: Drug: SHR-1501; Drug: SHR-1316

What is being measured

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

  1. Dose-limiting toxicity and Maximum tolerated dose

    Dose-limiting toxicity and Maximum tolerated dose in patients with advanced tumors treated by SHR-1501 combined with SHR-1316.

    Measured: Approximately 42 Days.

  2. Recommended Phase 2 dose (RP2D)

    Recommended Phase 2 dose (RP2D) based on comprehensive evaluation

    Measured: Approximately 2 years

  3. Adverse event/Serious adverse event

    Incidence/severity of adverse events/serious adverse events (rated based on CTC AE v5.0)

    Measured: Approximately 2 years

Secondary outcomes (25)

  1. Pharmacokinetic (PK)

    Single dose: maximum concentration (Cmax)

    Measured: Approximately 2 years

  2. Pharmacokinetic (PK)

    Single dose: time to maximum concentration (Tmax)

    Measured: Approximately 2 years

  3. Pharmacokinetic (PK)

    Single dose: areas under the concentration-time curve (AUClast and AUCinf)

    Measured: Approximately 2 years

  4. Pharmacokinetic (PK)

    Single dose: half-life (t1/2)

    Measured: Approximately 2 years

  5. Pharmacokinetic (PK)

    Single dose: clearance (CL)

    Measured: Approximately 2 years

  6. Pharmacokinetic (PK)

    Single dose: mean residence time (MRT)

    Measured: Approximately 2 years

  7. Pharmacokinetic (PK)

    Single dose: volume at steady state (Vss)

    Measured: Approximately 2 years

  8. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): maximum concentration at steady state （Css_max）

    Measured: Approximately 2 years

  9. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): time to maximum concentration （Tss_max）

    Measured: Approximately 2 years

  10. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): area under the concentration-time curve at steady state （AUCss）

    Measured: Approximately 2 years

  11. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): t1/2

    Measured: Approximately 2 years

  12. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable):steady-state minimum concentration at steady state （Css_min）

    Measured: Approximately 2 years

  13. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): average concentration at steady state（Css_av）

    Measured: Approximately 2 years

  14. Pharmacokinetic (PK)

    Multiple doses (at steady state, if applicable): accumulation ratio （Rac）

    Measured: Approximately 2 years

  15. Immune related features

    indicated by the count of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  16. Immune related features

    indicated by the percentage of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  17. Immune related features

    indicated by the count of natural killer (NK) cells in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  18. Immune related features

    indicated by the percentage of natural killer (NK) cells in peripheral blood at scheduled post-dose time points.

    Measured: Approximately 2 years

  19. Objective response rate

    Percentage of participants with CR or PR.

    Measured: Approximately 2 years

  20. Disease control rate

    Percentage of participants with CR or PR or SD.

    Measured: Approximately 2 years

  21. Duration of response

    Duration of time of tumor remission.

    Measured: Approximately 2 years

  22. progression-free survival

    Progression-free survival time.

    Measured: Approximately 2 years

  23. 12 months overall survival

    12-month survival rate.

    Measured: Approximately 2 years

  24. Durable clinical benefit rate at 6 month

    Percentage of participants with CR or PR or SD lasts over six months.

    Measured: Approximately 2 years

  25. Immunogenicity

    The immunogenicity of SHR-1501 single drug and the immunogenicity of SHR-1316 combined with SHR-1501. The indicator includes number of participants with anti-drug antibody positive or neutralizing antibody positive.

    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 posted24 Jun 2019
  2. Study start14 Feb 2020
  3. Primary completion12 Jan 2023
  4. Study completion12 Jan 2023

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03995472
Sponsor's protocol ID
SHR-1501-I-101
Status last verified
Sep 2023
First submitted
9 May 2019
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
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-1501 and SHR-1316 in people with Advanced Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 5 sites in 2 countries.

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 11 inclusion and 19 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, 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 and Maximum tolerated dose (time frame: Approximately 42 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 NCT03995472.

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 Sep 2023.

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