Your session is about to expire
← Back to Search
Monoclonal Antibody
OR2805 Monoclonal Antibody for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by OncoResponse, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects ≥ 18 and ≤ 100 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of dosing through every 90 after the last dose.
Awards & highlights
Study Summary
This trial will study a new cancer drug to see if it is safe and effective.
Who is the study for?
Adults aged 18-100 with various advanced cancers, including carcinoma, sarcoma, melanoma, and specific types like NSCLC. Participants must have finished previous cancer treatments at specified times before joining, be willing to use effective birth control if necessary, and have tumors measurable by RECIST v1.1 standards. They should not have certain medical conditions or be on conflicting medications.Check my eligibility
What is being tested?
The trial is testing OR2805 alone and combined with Cemiplimab or Docetaxel in patients with advanced solid tumors. It's an early-phase study assessing safety, tolerability, how the body processes the drugs (pharmacokinetics), their effects on the body (pharmacodynamics), and initial effectiveness against tumors.See study design
What are the potential side effects?
Potential side effects may include typical reactions to monoclonal antibodies such as infusion-related reactions; immune system complications that could affect organs; fatigue; allergic responses; plus any known side effects of Cemiplimab or Docetaxel like hair loss from chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 100 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 of dosing through every 90 after the last dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of dosing through every 90 after the last dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting Toxicity
Recommended Dose and Regimen (mono and combination therapy)
Safety and Tolerability
Secondary outcome measures
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Pharmacokinetics of OR2805
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: OR2805 monotherapy and combination therapy dose-expansion phase (Part B)Experimental Treatment3 Interventions
OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy or in combination with cemiplimab or docetaxel in subjects with NSCLC and melanoma.
Cemiplimab will be administered as an IV infusion at a dose of 350 mg.
Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2.
Group II: OR2805 monotherapy and combination therapy dose-escalation phase (Part A)Experimental Treatment3 Interventions
Escalating repeated doses of OR2805 by IV administration as monotherapy or in combination with cemiplimab or docetaxel in subjects with advanced solid tumors. OR2805 will be administered once every 3 weeks (Q3W) or once-weekly (QW) for 3 weeks as an IV infusion over 30 minutes.
Cemiplimab will be administered as an IV infusion at a dose of 350 mg.
Docetaxel will be administered as an IV infusion at a dose of 75 mg/m2.
Group III: OR2805 biological effects phase (Part C)Experimental Treatment1 Intervention
OR2805 administered IV at the RP2D and dosing regimen identified in Part A as monotherapy to determine the mechanism of action and potential predictors of response and pharmacodynamic markers in subjects with liposarcoma, leiomyosarcoma, or SCCHN or are not otherwise eligible for Cohort B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
OncoResponse, Inc.Lead Sponsor
1 Previous Clinical Trials
168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a past tumor sample and agree to a new biopsy for research.My side effects from previous treatments are mild or gone, except for hair loss or mild nerve pain.I have a diagnosis of advanced cancer that cannot be treated with surgery or local therapies.It's been over 2 weeks since my last hormone therapy and 3 weeks since any other cancer treatment.I have fluid buildup in my abdomen or around my lungs that causes symptoms.I am willing and able to follow the study's requirements.I have stable brain metastases and am not on high doses of steroids.My organs are functioning well.I am between 18 and 100 years old.I have a tumor that can be measured and possibly biopsied.I need help with my daily activities due to my health condition.I have had an organ or stem cell transplant.I had cancer other than the one being studied but have been free of it for over 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: OR2805 biological effects phase (Part C)
- Group 2: OR2805 monotherapy and combination therapy dose-escalation phase (Part A)
- Group 3: OR2805 monotherapy and combination therapy dose-expansion phase (Part B)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum participant capacity for this research endeavor?
"Affirmative. The information posted on clinicaltrials.gov verifies that the trial is presently enrolling participants, with an initial posting date of September 9th 2021 and a most recent update being made on September 30th 2022. 172 patients must be found from 3 distinct medical centres to complete enrollment in this study."
Answered by AI
What clinical conditions is OR2805 primarily used to alleviate?
"OR2805 is commonly prescribed for patients with unresectable melanoma, but can also help those suffering from microsatellite instability high and squamous cell carcinoma minimize their risk of a relapse."
Answered by AI
Has OR2805 been the subject of prior medical experimentation?
"OR2805 was first trialled in 2010 at City of Hope, leading to 848 completed studies. Currently, 1633 active trials are taking place around the country with many originating from San Antonio and Arizona."
Answered by AI
Are individuals still able to join this experiment?
"Per the clinicaltrials.gov website, this medical research has begun its recruitment process as of September 9th 2021 and was last amended on September 30th 2022."
Answered by AI
What are the intended outcomes of this trial?
"This trial's primary aim, to be evaluated over the initial 21 days of treatment, is to determine an ideal dosage and regimen (either mono or combination therapy). Secondary objectives involve exploring the pharmacokinetics of OR2805 with regards to Area under the plasma concentration versus time curve (AUC), gauging Objective Response Rate (ORR) according to RECIST v1.1., as well as assessing Progression Free Survival (PFS) which involves measuring from commencement of study therapy till disease progression/death occur first."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger