NCT06223256

A Study of NBL-028 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: NovaRock Biotherapeutics, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	NBL-028	Intravenous infusion (IV), once every two weeks (one treatment cycle is 4 weeks).

Timeline

• Start date: 2024-03-08
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-01-25
• Last updated: 2024-03-18

Locations

1 site across 1 country: China