Clinical trial · Interventional
A Trial of SHR-4849 Combined With Other Antitumor Drugs in Patients With 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
NCT07028281CI-TRIAL-00104406recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-4849 injection combined with other antitumor drugs in patients with malignant solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group A
- interventionNames
- Drug: SHR-4849、SHR-1316、SHR-8068、BP102、carboplatin、cisplatin
Primary outcomes (3)
- measure
- DLT：the incidence of events associated with the investigational drug determined by the investigator during the observation period(The first stage)
- timeFrame
- up to 21 days
- measure
- Incidence and severity of AE/SAE：According to NCI-CTCAE v5.0 evaluation criteria, from the signing of informed consent to the end of safety follow-up(The first stage)
- timeFrame
- up to 24 months
- measure
- Objective Response Rate (ORR) as Assessed by investigators(The second stage)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available
No reference posted for this study.