Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

BH3120: BH3120 will be administered as an IV infusion over 90 minutes on Day 1 of every 3-week treatment cycle

pembrolizumab: Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle

Study summary

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.

Eligibility

Primary outcome measure(s)

• Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. — Throughout the study until end of safety follow-up period (90 days after the last treatment)
  To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration
• Incidence and nature of DLTs — At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
  To evaluate safety and tolerability of BH3120 as a single agent and in combination with pembrolizumab administration

Trial sites (10)

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