Clinical trial · Interventional
A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients
- 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 safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.
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 |
|---|---|---|---|
| Advanced Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group
- interventionNames
- Drug: SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection
Primary outcomes (3)
- measure
- Maximum tolerated dose
- timeFrame
- first dose of study medication up to 21 days
- description
- The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
- measure
- Recommended phase II dose
- timeFrame
- first dose of study medication up to 21 days
- description
- The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Male or female aged ≥18 years and ≤70 years at the time of signing the ICF; 3. Histopathologically or cytologically documented advanced or metastatic malignancies; 4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 5. Life expectancy ≥12 weeks; 6. Adequate organ functions as defined; 7. Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding. Exclusion Criteria: 1. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 2. Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ; 3. Patients with tumor-related pain that cannot be controlled as determined by the investigator; 4. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 5. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment; 6. Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment; 7. Patients who have received \>30 Gy of radical radiotherapy within 28 days before the first dose of study treatment; 8. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy; 9. Use of live attenuated vaccines within 28 days before the first dose of the study treatment; 10. Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment; 11. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy; 12. History of autoimmune diseases; 13. History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment; 14. History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment; 15. Evidence or history of arterial/venous thrombosis within 3 months before the first dose; 16. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 17. Known history of serious allergic reactions to the investigational product or its main ingredients; 18. History of immunodeficiency; 19. Presence of active hepatitis B or active hepatitis C; 20. Severe infections within 4 weeks prior to the first study treatment; 21. Evidence or history of active pulmonary tuberculosis within 1 year before study entry; 22. any other conditions that are not suitable for participation in the study in the investigator's opinion.
References
Publications (0)
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