A Study of the Safety and Tolerability of IBI321 in Patients With Advanced Solid Tumors

NCT04911881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-03-01

No results posted yet for this study

Summary

This first-in-human open-label,dose-escalation study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable.

Conditions

Interventions

DRUG

IBI321

Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2023-02-23
Completion
2023-02-23

Countries

  • China

Study Locations

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Entities

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 NCT04911881 on ClinicalTrials.gov