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

NCT06223256 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2024-03-18

No results posted yet for this study

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

DRUG

NBL-028

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

Sponsors & Collaborators

  • NovaRock Biotherapeutics, Ltd

    lead INDUSTRY

Principal Investigators

  • Ruihua Xu, Ph.D · Sun Yat-Sen University (SYSU) Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223256 on ClinicalTrials.gov