Your Chart
For Patients
Call Us First

OCSRI

×

Study Name: Kl264-01 (KPKL264I01)

Status:

Recruiting

Disease Site:

Gastric

Phase:

Phase I, Phase II

Official Title:

Kl264-01 (KPKL264I01) 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:

clinicaltrials.gov/show/NCT04152499

Eligibility:

Male and Female – 18 years and older

Inclusion Criteria:

  • Gastric adenocarcinoma or GE junction adenocarcinoma (GE junction is defined as tumor with center located within 5cm below/above the anatomical esophagogastric junction per Siewert classification)
  • Pts who have been treated with only 1 prior tx of chemo and anti- PD-1/L1 and progressed during/after treatment
  • Prior neoadjuvant/adjuvant tx will be considered a line if pt progressed to unresectable locally advanced, recurrent or metastatic during or within 6 months of completing tx
  • Measurable Disease

Exclusion Criteria:

  • Uncontrolled HTN/DM:   ≥ 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 (pts with stable control of lower limb DVT is allowed)