NCT05924906

A Dose Escalation and Expansion Study of NB002 in Participants With Advanced or Metastatic Solid Tumors

Phase 1a/1b, First-in-Human, Open Label, Dose Escalation and Dose Expansion Study of NB002, a Multifunctional TIM-3 Blocking Antibody, in Subjects With Advanced or Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Suzhou Neologics Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a first-in-human, multicenter, open label, uncontrolled, non-randomized, phase 1a/1b study, to evaluate the safety, tolerability, and preliminary antitumor activity of NB002 in subjects with advanced solid tumors.

Detailed description

This study is a first-in-human, multicenter, open-label, uncontrolled, non-randomized, phase 1a/1b study. The study consists of a dose escalation part and a dose expansion part. In the escalation part, the primary objectives are to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) to establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or maximum administered dose (MAD) of NB002. The expansion part is to further evaluate the safety and tolerability of NB002 at the RDE dose established in the dose escalation part and to explore antitumor activity in the selected population. All subjects will be treated with NB002 via IV infusion at predefined dose levels Q3W on Day 1 of each 21-day Cycle. The design of the dose escalation part will be provided below. Further details on dose expansion part will be updated later once more information on potentially benefiting tumor types is confirmed.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	NB002	Strength: 100 mg:5 mL solution in a single-use vial Administration: intravenous infusion

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2023-06-29
• Last updated: 2023-07-03

Regulatory

• FDA-regulated drug study