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

NCT06059508 | Unknown Phase 1

• 1 other identifier: SHR-5495-I-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (5)

• Dose limited toxicity (DLT) of SHR-5495

  up to 21 days

• AEs+SAEs

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

• Maximum tolerated dose（MTD）of SHR-5495

  up to 21 days

• Maximum administrated dose（MAD）of SHR-5495

  up to 21 days

• Recommended Phase II Dose (RP2D) of SHR-5495

  up to 21 days

Secondary Outcomes (14)

• Evaluation of pharmacokinetic parameter of SHR-5495: Cmax

  12 months

• Evaluation of pharmacokinetic parameter of SHR-5495: Tmax

  12 months

• Evaluation of pharmacokinetic parameter of SHR-5495: AUClast

  12 months

• Evaluation of pharmacokinetic parameter of SHR-5495: AUCinf

  12 months

• Evaluation of pharmacokinetic parameter of SHR-5495: t1/2

  12 months

Study Arms (1)

SHR-5495 for injection

EXPERIMENTAL

Drug: SHR-5495 for injection

Interventions

SHR-5495 for injection DRUG

SHR-5495 for injection

SHR-5495 for injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University Affiliated Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Li Song

CONTACT

+86-0518-81220121; li.song@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: October 25, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-07

Locations

CN (1)