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ORB-021 for Cancer (OR2-01 Trial)

Phase 1

Waitlist Available

Research Sponsored by Orionis Biosciences Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Age 18 years or older

Must not have

Active infection with Tuberculosis, Hepatitis B (HBV) or hepatitis C Virus (HBC), HIV, SARS-COV2 (PCR positive)

Patients with prior grade 3 irAE or any irAE that resulted in discontinuation of PD-1 or PD-L1 ICI treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new drug called ORB-021 to see if it is safe for people with advanced solid tumors. The study will also try to find the best dose of the drug for

Who is the study for?

This trial is for individuals with advanced solid tumors. Participants must meet certain health criteria, but the specific inclusion and exclusion details are not provided here.

What is being tested?

The study tests ORB-021, a new drug by Orionis Biosciences, to see if it's safe for people with advanced solid tumors and to find the best dose. The trial includes screening, treatment, and end of treatment phases.

What are the potential side effects?

Specific side effects of ORB-021 aren't listed here. Generally, cancer drugs can cause fatigue, nausea, pain at injection sites among other symptoms; participants will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My solid tumor has come back or hasn't responded to treatment, and I can safely have more biopsies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active TB, Hepatitis B or C, HIV, or COVID-19.

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I stopped PD-1 or PD-L1 treatment due to severe side effects.

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I do not have any serious illnesses that would stop me from following the study's requirements, except for mild UTIs.

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I am not pregnant or breastfeeding.

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I have ongoing painful swelling of my kidney due to urine buildup.

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I have a brain tumor or brain metastasis that hasn't been treated or is causing symptoms.

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I have seizures that are not controlled by medication.

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I have received an organ from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-011

Secondary study objectives

Determine Recommended Phase 2 Dose (RP2D)

Other study objectives

Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-021

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Dose Escalation ORB-021Experimental Treatment1 Intervention

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.

0 / 11Eligibility criteria met