SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors (NCT05631262) | Clinical Trial Compass
Active — Not RecruitingPhase 2
SKB264 Monotherapy in Selected Subjects With Advanced Solid Tumors
China321 participantsStarted 2022-11-30
Plain-language 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 â… consists of 5 cohorts, and the Part â…¡ 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
✓. The following histologically or cytologically confirmed tumor types will be enrolled:
✓. 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;
✓. 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;
✓. For subjects enrolled in Part I Cohort 3, the following criteria must be met:
✓. For subjects enrolled in Part I Cohort 4, the following criteria must be met:
✓. For subjects enrolled in Part I Cohort 5, the following criteria must be met:
✓. PD as assessed by imaging on or after the most recent treatment for locally advanced or metastatic disease;
Exclusion criteria
✕. For NSCLC, histologically or cytologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components;
✕. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active brain metastases.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From baseline until disease progression, death, or other protocol defined reason, up to approximately 21 months.
2
Incidence and severity of adverse events (AEs)
Timeframe: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment.
. Other malignancies within 3 years prior to the first dose;
✕. Presence of any cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors:
✕. Uncontrolled systemic disease as judged by the investigator:
✕. 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;
✕. Clinically serious lung injuries caused by lung diseases, including but not limited to any underlying lung diseases or prior pneumonectomy;
✕. Presence of active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute GI tract bleed;