ORB-021 In Patients With Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Orionis Biosciences Inc
Study ID
NCT06607939
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ORB-021 — DRUG
    ORB-021 is dosed via IV infusion

Study Details

The goal of this clinical research study is to determine if an investigational new drug, named ORB-021, 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.

Key Dates

Start date
Nov 21, 2024
Status verified
Feb 2026
Primary completion
May 29, 2026
Completion
May 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Dose Escalation ORB-021
    ORB-012 Dose Escalation Participants will be administered study drug at dose levels corresponding to their Cohort. Cohort 1 will be treated with the lowest dose, and the dose will be escalated for future cohorts once the previous dose has been observed not to be associated with DLTs. Up to 5 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates.

Primary Outcome Measure

Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-011 [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Honor Health Clinical ResearchScottsdaleArizona85258
Justin Moser, MD Associate Clinical Investigator, HonorHealth, MD
[email protected]
+1 480-583-7219
Justin Moser, MD Associate Clinical Investigator, HonorHealth, MD (PRINCIPAL_INVESTIGATOR)
MDACHoustonTexas77030
Aung Naing, MD
[email protected]
Ashabari Sprenger, PhD
[email protected]
713-834-6993
Aung Naing, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
Honor Health Clinical Research· Scottsdale, AZMDAC· Houston, TX

Related Studies