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Advanced Malignant TumorPhase 1NCT06059508

Phase I Clinical Study of SHR-5495 in the Treatment of Patients With Advanced Malignant Tumors

A Phase 1 study testing SHR-5495 for injection in people with Advanced Malignant Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Malignant Tumor
What is being tested?
SHR-5495 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
25 Oct 2023to 31 Dec 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range from 18 to 70 years old (including 18 and 70 years old), both male and female
  • Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan
  • ECOG score: 0-1
  • Expected survival time ≥ 12 weeks
  • Existence of measurable lesions that meet RECIST 1.1 standards
  • Sufficient Hematology and end organ function shall be completed within 7 days before the first study treatment
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  • Left ventricular Ejection fraction (LVEF) ≥ 50% within 28 days before the first administration
  • Women of childbearing age must carry out serum Pregnancy test within 7 days before the first administration, and the result is negative. Female subjects of childbearing age and male subjects with partners of childbearing age must agree to use efficient methods of contraception or abstinence within at least 26 weeks (female subjects) or 14 weeks (male subjects) from the date of signing the informed consent form until the last administration
  • The patient voluntarily joined this study, signed an informed consent form, had good understand the research procedures, and have signed informed consent

Who cannot join

  • Has received treatment with interleukin
  • Previously received immune checkpoint inhibitors
  • Central nervous system metastasis with clinical symptoms in patients
  • The third space effusion with clinical symptoms needs repeated drainage, such as pericardial effusion, Pleural effusion and peritoneal effusion that cannot be controlled after pumping or other treatment
  • Subjects who received anti-tumor therapy and systemic immune stimulation therapy within 4 weeks prior to the first dose of the study drug; Received traditional Chinese patent medicines and simple preparations anti-tumor treatment within 2 weeks before the first dose of study drug
  • Subjects who received>30Gy of non thoracic radical radiation therapy within 28 days before the first medication, those who received>30Gy of chest radiation therapy within 24 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 14 days before the first medication
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  • Subjects who have received systemic Immunosuppressive drug treatment within 2 weeks before the first administration, or who are expected to require systemic immunosuppressive drug treatment during the study treatment.
  • Patients who have not recovered to ≤ CTCAE level 1 (CTCAE v5.0) due to adverse events caused by previous treatment
  • Having autoimmune diseases
  • Other malignant tumors within 2 years before screening, excluding fully treated cervical Carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal Carcinoma in situ after radical surgery
  • Subjects with known or suspected interstitial pneumonia; Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function
  • Subjects with severe cardio cerebral Vascular disease
  • Clinically significant bleeding symptoms or tendency to bleed within one month before the first administration
  • Arteriovenous thrombotic events that occurred within 3 months before the first administration
  • Uncontrolled tumor related pain or symptomatic hypercalcemia. Subjects who require painkillers must already have a stable painkillers treatment plan at the time of entry into the study; Symptomatic lesions suitable for palliative radiotherapy should be treated before entering the study
  • Active hepatitis B or active hepatitis C
  • Abnormal electrocardiogram (ECG) examination, judged by the researcher to have clinical significance
  • Have a history of immune deficiency
  • Evidence of active tuberculosis infection within 1 year prior to the first administration, or a history of active tuberculosis infection more than 1 year ago without formal treatment
  • Serious infection occurred within 4 weeks before the first administration; Active infections that have received therapeutic intravenous or oral antibiotics within 2 weeks prior to starting the study.
  • History of live attenuated vaccine administration within 28 days prior to initial administration or expected study period
  • Within 28 days prior to the first administration, major surgeries other than diagnosis or biopsy have been performed; Traumatic minor surgery experienced within 7 days prior to first administration
  • Subjects who have previously received or are preparing to receive allogeneic bone marrow transplantation or solid organ transplantation
  • Has a history of severe allergic reactions to other monoclonal antibodies/fusion protein drugs, and is allergic to any component of the research treatment plan
  • Female subjects during pregnancy, lactation, or planning to conceive during the study period
  • The subject has a known history of psychotropic substance abuse, alcoholism, or drug abuse
  • Researchers believe that any other medical, psychiatric, or social condition may interfere with the subjects' rights, safety, health, or ability to sign informed consent, cooperate and participate in the study, or interfere with the evaluation of the study medication

Trial locations and contacts

1 site in 1 country.

Li Song contact

+86-0518-81220121

li.song@hengrui.com

China1 site, 1 recruiting

  • Shandong First Medical University Affiliated Cancer Hospital

    Jinan, Shandong, 250117

    Jinming Yu

    Yuping Sun

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5495 for Injection in Patients With Advanced Malignancies

This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.

Being tested
SHR-5495 for injection

What participants receive

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

  • SHR-5495 for injectionDrug

    SHR-5495 for injection

Study groups in NCT06059508
Study groupRoleWhat they receive
SHR-5495 for injectionExperimentalNot described
Receives: Drug: SHR-5495 for injection

What is being measured

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

  1. Dose limited toxicity (DLT) of SHR-5495

    Measured: up to 21 days

  2. AEs+SAEs

    Measured: from the first drug administration to within 90 days for the last treatment dose

  3. Maximum tolerated dose（MTD）of SHR-5495

    Measured: up to 21 days

  4. Maximum administrated dose（MAD）of SHR-5495

    Measured: up to 21 days

  5. Recommended Phase II Dose (RP2D) of SHR-5495

    Measured: up to 21 days

Secondary outcomes (14)

  1. Evaluation of pharmacokinetic parameter of SHR-5495: Cmax

    Measured: 12 months

  2. Evaluation of pharmacokinetic parameter of SHR-5495: Tmax

    Measured: 12 months

  3. Evaluation of pharmacokinetic parameter of SHR-5495: AUClast

    Measured: 12 months

  4. Evaluation of pharmacokinetic parameter of SHR-5495: AUCinf

    Measured: 12 months

  5. Evaluation of pharmacokinetic parameter of SHR-5495: t1/2

    Measured: 12 months

  6. Evaluation of pharmacokinetic parameter of SHR-5495: CL

    Measured: 12 months

  7. Evaluation of pharmacokinetic parameter of SHR-5495: Vss

    Measured: 12 months

  8. Receptor occupancy rate

    Measured: 12 months

  9. Objective Response Rate (ORR)

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  10. Duration of response (DoR)

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  11. Disease control rate (DCR)

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  12. Progression free survival（PFS）

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  13. Overall survival (OS)

    Measured: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  14. Target cell count

    Measured: 12 months

Timeline

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

  1. First posted28 Sep 2023
  2. Study start25 Oct 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059508
Sponsor's protocol ID
SHR-5495-I-101
Status last verified
Jul 2023
First submitted
20 Sep 2023
Last updated
7 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-5495 for injection in people with Advanced Malignant Tumor, 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 9 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li Song (+86-0518-81220121, li.song@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicity (DLT) of SHR-5495 (time frame: up to 21 days). The study lists 5 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 NCT06059508.

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 7 Nov 2023.

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