West China Hospital is conducting a Phase Ib clinical study titled “A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of SYS6010 Monotherapy in Patients with Advanced Solid Tumors.”
The study plans to recruit up to 806 subjects nationwide. It has been approved by the National Medical Products Administration (NMPA) and the Ethics Committee of our hospital.
Inclusion Criteria
1. Voluntarily participate in this clinical study, understand the procedures, and be able to sign written informed consent;
2. Age 18–75 years (inclusive), any gender;
3. Enroll EGFR‑positive small cell lung cancer (SCLC) patients who have failed first‑line treatment with platinum‑based chemotherapy and PD‑(L)1 antibody, confirmed histologically or cytologically;
4. At least one measurable lesion as defined by RECIST 1.1 at baseline;
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0‑1.
Exclusion Criteria
1. Previous treatment with topoisomerase I inhibitor chemotherapeutic agents (including ADC drugs with topoisomerase I inhibitors as the toxin);
2. Leptomeningeal metastasis; spinal cord compression; symptomatic and unstable brain metastases, unless the subject has completed curative treatment and has been stable without steroid therapy for at least 2 weeks prior to randomization. Asymptomatic brain metastases may be included if the investigator deems no immediate curative treatment is indicated;
3. History of interstitial lung disease (ILD) requiring steroid therapy, drug‑induced ILD, radiation pneumonitis, or any evidence of clinically active ILD.
The above are the main selection criteria. If you meet all entry criteria after screening, you will be formally enrolled in this study.
For more information about this study, please contact:
Contact: Chen
Phone: 13378329919
