Study of XB010 in Subjects With Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

XB010: IV administration of XB010

Pembrolizumab: IV administration of Pembrolizumab

Study summary

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.

Eligibility

Primary outcome measure(s)

• Dose-Escalation Stage: Maximum tolerated dose (MTD) and/or Recommended dose(s) for Expansion [RDE(s)] for XB010 — 18 months
  To determine the MTD and/or RDE(s) for further evaluation of IV administration of XB010 alone and in combination therapy.
• Dose-Escalation Stage: Safety of XB010 — 18 months
  To evaluate the safety of XB010 alone and in combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)
• Dose-Escalation Stage: Duration of exposure of XB010 [Tolerability] — 18 months
  To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the duration of exposure of each component
• Dose-Escalation Stage: Dose intensity of XB010 [Tolerability] — 18 months
  To evaluate the tolerability of XB010 alone and in combination therapy through the evaluation of the dose intensity of each component
• Cohort-Expansion Stage: Preliminary antitumor activity of XB010 — 24 months
  Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1

Trial sites (20)