Status:
Recruiting
Disease Site:
Bladder
Phase:
Phase I, Phase II
Official Title:
A Phase I-II, First in Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
NCT ID:
NCT#04152499
Link to Full Details:
Eligibility:
Male and Female – 18 years and older
Inclusion Criteria:
- Urothelial carcinoma (including urothelial carcinoma of the renal pelvis, bladder, ureter, or urethra)
- Mixed histologies are eligible provided the urothelial component is > 50% and plasmacytoid is < 10%; Pts whose tumors contain any neuroendocrine component are not eligible
- Measurable Disease
- Pts who have failed prior first-line platinum-based treatment and received prior anti-PD-1/L1 and progressed during/after the latest treatment
- Prior neoadjuvant/adjuvant will be counted as a line of treatment if the patient progressed to unresectable locally advanced, recurrent or metastatic during or within 12 months after completing treatment
Exclusion Criteria:
- Uncontrolled hypertension or diabetes: BP ≥ 160/100 or HbA1C ≥9.0%
- Ascites requiring paracentesis >1 per week
- Symptomatic pleural effusion (<90% oxygen saturation)
- New diagnosis of thromboembolic events that requires therapeutic intervention over the last 6 months (stable control of lower limb DVT is allowed)