SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of SKB264 monotherapy in subjects with selected advanced solid tumors.The study is divided into two parts: the Part Ⅰ consists of 4 cohorts, and the Part Ⅱ for expansion. Eligible subjects will receive SKB264 monotherapy, until there is no longer clinical benefit, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Criteria

Inclusion Criteria:

1. Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;

2. The following histologically or cytologically confirmed tumor types will be enrolled:

• Part Ⅰ Cohort 1, Cohort 2, Cohort 3, and Part Ⅱ: histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC), locally advanced (stage ⅢB/ⅢC) or metastatic (stage Ⅳ) NSCLC not amenable to radical surgery and/or radical radiotherapy (regardless of concurrent/sequential chemotherapy) ;

• Part Ⅰ Cohort 4: histologically or cytologically confirmed nonkeratinizing differentiated or undifferentiated nasopharyngeal carcinoma (NPC) with metastatic (stage ⅣB) NPC not amenable to radical local therapy ;

3. Ability to provide fresh or archival tumor tissue for biomarker testing and analysis.

4. At least one measurable target lesion per RECIST 1.1; brain lesions will not considered as target lesions;

5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

6. Expected survival ≥ 12 weeks;

7. Adequate organ and bone marrow function;

8. Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception during the study treatment period and for 6 months after the end of dosing;

9. Subjects who voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol- specified visits and relevant procedures.

Exclusion Criteria:

1. For NSCLC, histologically or cytologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components;

2. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active brain metastases.

3. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;

4. History of (noninfectious) interstitial pneumonia (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;

5. Subjects with HIV test positive or history of AIDS; known active syphilis infection;

6. Pregnant or lactating women;

7. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 2 weeks prior to the first dose;

8. Requiring strong inhibitors or inducers of CYP3A4 within 2 weeks prior to first dose and during the study (strong inhibitors or inducers of CYP3A4 are not allowed in this study);

9. Live vaccines inoculated within 30 days prior to the first dose or planned to be inoculated during the study.