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ORB-011 In Patients With Advanced Solid Tumors

NCT05947474 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-02-10

No results posted yet for this study

Summary

The goal of this clinical research study is to determine if an investigational new drug, named ORB-011, developed by Orionis Biosciences is safe and can be tolerated in people diagnosed with an advanced solid tumor.

The study also aims to find the biologically optimal dose of the study medicine by assessing the safety and potential activity in the treatment of solid tumors.

There are three phases to this study: screening, treatment and end of treatment.

Conditions

  • Advanced Solid Cancer

Interventions

DRUG

ORB-011

Drug: ORB-011 is dosed via IV infusion

Sponsors & Collaborators

  • Orionis Biosciences Inc

    lead INDUSTRY

Principal Investigators

  • Robert Petit, PhD · SVP Early Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

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 NCT05947474 on ClinicalTrials.gov