Evaluating SHR-4849 for Advanced Solid Tumors

A Phase I ,Open-label, Multicenter Clinical Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Efficacy of SHR-4849 in Patients With Advanced Solid Tumors

This study is testing a new injection called SHR-4849 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jilin, Changchun)
• Trial ID: NCT06443489 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, and efficacy of SHR-4849 injection in patients with advanced solid tumors. The study will explore the appropriate dosage of SHR-4849 while monitoring participants for any adverse effects. Eligible patients will receive the treatment and be evaluated based on measurable lesions as per RECIST 1.1 criteria. The trial is designed to gather data that could inform future treatment protocols for this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with histologically confirmed advanced solid tumors and a life expectancy of at least 3 months.

Not a fit: Patients with active central nervous system metastasis or those with severe cardiovascular disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in targeting advanced solid tumors with novel therapies.

Eligibility criteria

Inclusion Criteria:

1. Subject has provided informed consent prior to initiation of any study-procedures
2. Age from 18 to 75 years old at the time of signing the informed consent
3. Histologically or cytologically confirmed advanced solid tumors
4. At least one measurable lesion was identified per RECIST 1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
6. Has a life expectancy of at least 3 months.
7. Adequate organ function
8. Subjects of both genders of child-bearing potential were required to use highly effective contraception from the time they provided written informed consent until 6 months after the last dose of the trial drug

Exclusion Criteria:

1. Subjects with active central nervous system (CNS) metastasis.
2. Subjects with a history of malignant tumors within 5 years prior to the first dose
3. Subjects with uncontrolled cancer pain.
4. Subjects with severe cardiovascular disease.
5. Subjects with clinically significant hemorrhage
6. Subjects with uncontrolled pleural effusion, peritoneal effusion and pericardial effusion
7. Subjects highly suspected of interstitial lung disease
8. Subjects with serious infection within 4 weeks prior to the first dose
9. Known history of human immunodeficiency virus (HIV)，active hepatitis B virus or hepatitis C virus infection.
10. The adverse events of previous antineoplastic therapy did not recover to NCI-CTCAE≤ grade 1
11. Subjects who received anti-cancer treatment within 4 weeks prior to the first dose
12. Subjects who received major surgery within 4 weeks prior to the first dose
13. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
14. Female subjects who were pregnant, lactating, or planned to become pregnant during the study period
15. Known allergic to any component of SHR-4849 products
16. Alcohol abuse, drug abuse, other serious medical conditions (including mental illness) requiring combined treatment, and other conditions that may affect subject safety or data collection.
17. Based on the investigator's judgment, subjects with other conditions that may affect study results, interfere with study procedures,

Where this trial is running

Jilin, Changchun

• Jilin Cancer Hospital — Jilin, Changchun, China (Recruiting)

Study contacts

• Study coordinator: wei Hou

Conditions Advanced Solid Tumors