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RECRUITING
NCT06223256
PHASE1

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

Sponsor: NovaRock Biotherapeutics, Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

270

Start Date

2024-03-08

Completion Date

2027-01

Last Updated

2024-03-18

Healthy Volunteers

No

Interventions

DRUG

NBL-028

Intravenous infusion (IV), once every two weeks (one treatment cycle is 4 weeks).

Locations (1)

No.896 East Zhongshan Road, Shijiazhuang, Hebei Province, China.

Shijiazhuang, Hebei, China