SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

Trial Title: SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors

NCT ID: NCT05631262

Condition: Selected Subjects With Advanced Solid Tumors

Conditions: Official terms:
Neoplasms
Docetaxel

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SKB264
Description: Subjects of Cohot 1-5 and Part II Test group will receive SKB264 monotherapy
Arm group label: Part II Test group
Arm group label: SKB264 (Cohort 1)
Arm group label: SKB264 (Cohort 2)
Arm group label: SKB264 (Cohort 3)
Arm group label: SKB264 (Cohort 4)
Arm group label: SKB264 (Cohort 5)

Intervention type: Drug
Intervention name: Docetaxel
Description: Part II Control group will receive docetaxel monotherapy.
Arm group label: Part II Control group

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 5 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.

Detailed description: The second part of this study is a randomized, open-label, multicenter Phase 2 clinical study of SKB264 monotherapy versus docetaxel in subjects with locally advanced or metastatic non-squamous NSCLC.

Criteria for eligibility:
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, Cohort 5 and Part Ⅱ: histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC); - Part Ⅰ Cohort 4: histologically or cytologically confirmed nonkeratinizing differentiated or undifferentiated nasopharyngeal carcinoma (NPC) ; 3. For subjects enrolled in Part I Cohort 1 and Part II, the following criteria must be met:①EGFR-sensitive mutations confirmed by tumor histology or cytology or hematology;②Failure of prior EGFR-TKI therapy and chemotherapy; 4. For subjects enrolled in Part I Cohort 2, the following criteria must be met:①EGFR-sensitive mutations confirmed by tumor histology or cytology or hematology;②Failure of prior EGFR-TKI therapy;③No prior systemic therapy for locally advanced or metastatic NSCLC other than EGFR-TKI therapy; 5. For subjects enrolled in Part I Cohort 3, the following criteria must be met: ①NSCLC confirmed by tumor histology to be EGFR wild-type and negative for ALK fusion gene; ②Subjects must have met one of the following conditions for prior systemic therapy:A. Have received platinum-based chemotherapy in combination with anti-PD-1/L1 monoclonal antibody therapy as the only prior first-line therapy;B. Have received sequential treatment with platinum-based chemotherapy and anti-PD-1/L1 monoclonal antibody (in either order) as the only prior second-line therapy; 6. For subjects enrolled in Part I Cohort 4, the following criteria must be met: Have received prior second-line or above systemic therapies and have progressed on or after treatment, with prior therapies including platinum-based chemotherapy and anti-PD-1/PD-L1 monoclonal antibody therapy; 7. For subjects enrolled in Part I Cohort 5, the following criteria must be met: ①The presence of other driver gene alterations confirmed by tumor histology or cytology or hematology other than EGFR-sensitive mutations ;②have failed targeted therapy for applicable genetic alterations or chemotherapy; 8. PD as assessed by imaging on or after the most recent treatment for locally advanced or metastatic disease; 9. Ability to provide fresh or archival tumor tissue for biomarker testing and analysis. 10. At least one measurable target lesion per RECIST 1.1; 11. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 12. Expected survival ≥ 12 weeks; 13. Adequate organ and bone marrow function; 14. 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; 15. 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. Other malignancies within 3 years prior to the first dose; 4. Presence of any cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors: 5. Uncontrolled systemic disease as judged by the investigator: 6. 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; 7. Clinically serious lung injuries caused by lung diseases, including but not limited to any underlying lung diseases or prior pneumonectomy; 8. Presence of active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute GI tract bleed; 9. Toxicities treated by prior anti-tumor therapy having not recovered to ≤ Grade 1 (as per NCI CTCAE V5.0) or to the levels specified in the eligibility criteria; 10. Presence of active hepatitis B or hepatitis C; 11. Subjects with HIV test positive or history of AIDS; known active syphilis infection; 12. Known allergy to the study drug or any of its components, and a history of known severe hypersensitivity to other monoclonal antibodies; 13. Prior TROP2-targeted therapy; 14. Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs); 15. Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study; 16. Systemic anti-infective therapy within 2 weeks prior to the first dose; 17. Receipt of any systemic anti-tumor therapy such as macromolecular targeted therapy, immunotherapy, etc. within 4 weeks prior to the first dose; receipt of small molecule TKIs, nonspecific immunomodulatory therapy , and Chinese patent drug preparations for approved anti-tumor indications within 2 weeks prior to the first dose; 18. Ongoing long-term systemic corticosteroid therapy of > 10 mg prednisone or equivalent dose of systemic corticosteroids or equivalent anti-inflammatory active medication or any form of immunosuppressive therapy prior to the first dose; 19. Live vaccines inoculated within 30 days prior to the first dose or planned to be inoculated during the study; 20. Rapid deterioration of disease, such as significant changes in performance status during the screening process prior to the first dose; 21. Pregnant or lactating women; 22. Presence of local or systemic diseases caused by non-malignancies; or diseases or symptoms secondary to tumors that can lead to high medical risks and/or uncertainties in survival evaluation; 23. Any condition that, in the opinion of the investigator, make the subject unsuitable for participation in this study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Sun Yat-sen University Cancer Center

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Li Zhang

Phone: +86-020-87343458
Email: zhangli@sysucc.org.cn

Start date: November 30, 2022

Completion date: October 30, 2025

Lead sponsor:
Agency: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Agency class: Industry

Source: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05631262