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Advanced Malignant CancerPhase 1NCT06131216

Phase I Study of SHR-2022 Injection in the Treatment of Patients With Advanced Malignant Tumors

A Phase 1 study testing SHR-2022 Injection in people with Advanced Malignant Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Malignant Cancer
What is being tested?
SHR-2022 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
No sites listed yet
Study dates
Dec 2023to Dec 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
  • Age 18-80 years old (including both ends), both male and female
  • Subjects with advanced or metastatic malignant tumors confirmed by pathological tissue or cytology, and who have failed previous standard treatments, are intolerant to standard treatments, or have no standard treatments
  • Have measurable lesions
  • ECOG PS score: 0-1
  • Have a life expectancy of at least 3 months
  • The functional level of the major organs must meet the requirements
  • Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating

Who cannot join

  • Central nervous system metastasis or meningeal metastasis with clinical symptoms
  • Spinal cord compression that has not been treated radically by surgery and/or radiotherapy
  • Patients with uncontrolled tumor-related pain as judged by the investigator
  • A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator
  • Systemic antitumor therapy was administered within 28 days prior to treatment in the first study
  • Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period
Show all 21Show fewer
  • Received within 28 days prior to the first investigational dose Non-radical chest radiation therapy of 30Gy received within 24 weeks prior to initial dosing. Patients receiving 30Gy of chest radiation therapy, and those receiving palliative radiation ≤30Gy within 14 days prior to the first dose
  • The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1
  • Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment
  • Systemic immunosuppressive therapy was administered within 14 days prior to the first study
  • Accompanied by interstitial pneumonia or interstitial lung disease
  • Patients with a history of autoimmune disease
  • The first study studied patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before medication
  • The first study was conducted in subjects with severe cardiovascular and cerebrovascular disease within 6 months prior to medication
  • Arterial/venous thrombosis events occurred within 3 months prior to initial administration
  • The first study studied any other malignancy within 5 years prior to medication
  • A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients
  • Have a history of immune deficiency or organ transplantation, and have active hepatitis B or C
  • Severe infection within 4 weeks prior to the first dose
  • Patients with active pulmonary tuberculosis within 1 year prior to enrollment were found by history or CT examination
  • The presence of other serious physical or mental illness, known alcohol or drug dependence, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yanbo Liu contact

0518-82342973

yanbo.liu@hengrui.com

Zhenqun Lu contact

0518-82342973

zhenqun.lu@hengrui.com

About this study

Official title: Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-2022 Injection Alone or in Combination With Other Anti-tumor Treatments in Patients With Advanced Malignant Tumors

To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D

Being tested
SHR-2022 Injection

What participants receive

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

  • SHR-2022 InjectionDrug

    SHR-2022 Injection is administered by intravenous (IV) infusion

Study groups in NCT06131216
Study groupRoleWhat they receive
SHR-2022 InjectionExperimentalNot described
Receives: Drug: SHR-2022 Injection

What is being measured

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

  1. Incidence of adverse events

    Measured: up to 3 years

  2. Severity of adverse events

    Measured: up to 3 years

  3. MTD

    Measured: up to 3 years

  4. RP2D

    Measured: up to 3 years

Secondary outcomes (5)

  1. Time to maximum concentration (Tmax)

    Measured: up to 3 year

  2. Maximum concentration (Cmax)

    Measured: up to 3 year

  3. Receptor Occupancy（OR） of SHR-2022

    Measured: up to 3 year

  4. Anti-drug antibody (ADA) of SHR-2022

    Measured: up to 3 year

  5. Objective response rate (ORR)

    Measured: up to 3 year

Timeline

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

  1. First posted14 Nov 2023
  2. Study startDec 2023 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (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
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131216
Sponsor's protocol ID
SHR-2022-I-101
Status last verified
Nov 2023
First submitted
8 Nov 2023
Last updated
14 Nov 2023
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-2022 Injection in people with Advanced Malignant Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd..

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: opening soon, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 Yanbo Liu (0518-82342973, yanbo.liu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: up to 3 years). The study lists 4 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 NCT06131216.

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 14 Nov 2023.

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