SHR-4849 combined with other cancer drugs for malignant solid tumors

A Multicenter, Open-label, Phase II Clinical Study of SHR-4849 Injection Combined With Other Antineoplastic Drugs in Patients With Malignant Solid Tumors

This study will test whether adding SHR-4849 to other cancer drugs is safe and can help adults with malignant solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07028281 on ClinicalTrials.gov

What this trial studies

This phase 2 interventional trial gives adults with histologically confirmed malignant solid tumors combinations that include SHR-4849 plus agents such as SHR-1316, SHR-8068, BP102, carboplatin, or cisplatin. Eligible participants must be 18–75 years old, have at least one measurable lesion per RECIST 1.1, an ECOG performance status of 0–1, and adequate organ function. The trial collects safety, tolerability, and preliminary efficacy data through scheduled clinical assessments and imaging across different combination cohorts. Exclusion criteria include active CNS metastases, recent other malignancies within five years, uncontrolled cancer pain, severe cardiovascular disease, and significant bleeding.

Who should consider this trial

Good fit: Ideal candidates are adults (18–75) with histologically or cytologically confirmed malignant solid tumors, at least one measurable lesion, ECOG 0–1, adequate organ function, and agreement to required contraception measures if applicable.

Not a fit: Patients with active brain metastases, recent other cancers, uncontrolled cancer pain, severe heart disease, or clinically significant hemorrhage are unlikely to qualify or derive benefit in this trial.

Why it matters

Potential benefit: If successful, these combinations could provide a new treatment option that improves tumor control for some patients with advanced solid tumors.

How similar studies have performed: Combination approaches pairing targeted agents or immunotherapies with chemotherapy have shown benefits in other solid tumors, but SHR-4849-containing regimens are novel and currently unproven.

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 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 8 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 investigational drugs
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

Jinan, Shandong

• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Wei Hou

Conditions Malignant Solid Tumors