- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06059508
Phase I Clinical Study of SHR-5495 in the Treatment of Patients With Advanced Malignant Tumors
November 2, 2023 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li Song
- Phone Number: +86-0518-81220121
- Email: li.song@hengrui.com
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Recruiting
- Shandong First Medical University Affiliated Cancer Hospital
-
Principal Investigator:
- Yuping Sun
-
Principal Investigator:
- Jinming Yu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SHR-5495 for injection
|
SHR-5495 for injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limited toxicity (DLT) of SHR-5495
Time Frame: up to 21 days
|
up to 21 days
|
AEs+SAEs
Time Frame: from the first drug administration to within 90 days for the last treatment dose
|
from the first drug administration to within 90 days for the last treatment dose
|
Maximum tolerated dose(MTD)of SHR-5495
Time Frame: up to 21 days
|
up to 21 days
|
Maximum administrated dose(MAD)of SHR-5495
Time Frame: up to 21 days
|
up to 21 days
|
Recommended Phase II Dose (RP2D) of SHR-5495
Time Frame: up to 21 days
|
up to 21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of pharmacokinetic parameter of SHR-5495: Cmax
Time Frame: 12 months
|
12 months
|
Evaluation of pharmacokinetic parameter of SHR-5495: Tmax
Time Frame: 12 months
|
12 months
|
Evaluation of pharmacokinetic parameter of SHR-5495: AUClast
Time Frame: 12 months
|
12 months
|
Evaluation of pharmacokinetic parameter of SHR-5495: AUCinf
Time Frame: 12 months
|
12 months
|
Evaluation of pharmacokinetic parameter of SHR-5495: t1/2
Time Frame: 12 months
|
12 months
|
Evaluation of pharmacokinetic parameter of SHR-5495: CL
Time Frame: 12 months
|
12 months
|
Evaluation of pharmacokinetic parameter of SHR-5495: Vss
Time Frame: 12 months
|
12 months
|
Receptor occupancy rate
Time Frame: 12 months
|
12 months
|
Objective Response Rate (ORR)
Time Frame: 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
|
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
|
Duration of response (DoR)
Time Frame: 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
|
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
|
Disease control rate (DCR)
Time Frame: 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
|
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
|
Progression free survival(PFS)
Time Frame: 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
|
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
|
Overall survival (OS)
Time Frame: 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
|
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
|
Target cell count
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2023
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 20, 2023
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
September 28, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-5495-I-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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