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Monoclonal Antibodies

OR502 + Cemiplimab 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

- Parts A and B (Cohorts A1, A2, and B1): subjects must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy with curative intent

- Part B (Expansion Cohorts B2-B3): subjects must have a histological diagnosis of the relevant tumor type (CSCC or PROC) with advanced/metastatic disease not amenable to local therapy with curative intent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of dosing through 90 days after the last dose.

Awards & highlights

Study Summary

This trial tests a new cancer drug to see how safe and effective it is.

Who is the study for?

Adults with advanced solid tumors, including specific types like carcinoma, sarcoma, or melanoma that can't be treated with surgery. They must have tried standard cancer treatments without success or couldn't tolerate them. Participants need to have good organ function and agree to use effective birth control. Those with severe allergies to monoclonal antibodies or certain health conditions are excluded.Check my eligibility

What is being tested?

The trial is testing OR502 alone and combined with cemiplimab in people with advanced solid tumors. It's an early-phase study looking at safety, 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?

Possible side effects include reactions related to the immune system due to OR502 and cemiplimab, which could lead to inflammation in various organs. Other common side effects might involve fatigue, skin reactions, digestive issues, and potential changes in blood tests.

Eligibility Criteria

Inclusion Criteria

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

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I have a diagnosis of cancer (carcinoma, sarcoma, or melanoma) that is worsening and cannot be cured with surgery or local treatments.

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I have CSCC or PROC with advanced cancer that cannot be treated with surgery for a cure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of dosing through 90 days after the last dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of dosing through 90 days after the last dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of dosing through 90 days after the last dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events and Serious Adverse Events

Dose-limiting Toxicity

Recommended Dose and Regimen (mono and combination therapy)

+1 more

Secondary outcome measures

Disease Control Rate (DCR)

Objective Response Rate (ORR)

Pharmacokinetics of OR502

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: OR502 monotherapy and combination therapy dose-expansion phase (Part B)Experimental Treatment2 Interventions

OR502 administered IV at 2 different dose levels identified in Part A as monotherapy or in combination with cemiplimab in subjects with platinum-resistant ovarian cancer and cutaneous squamous cell carcinoma. Cemiplimab will be administered as an IV infusion at a dose of 350 mg.

Group II: OR502 monotherapy and combination therapy dose-escalation phase (Part A)Experimental Treatment2 Interventions

Escalating repeated doses of OR502 by IV administration as monotherapy or in combination with cemiplimab in subjects with advanced solid tumors. OR502 will be administered once every 3 weeks (Q3W). Cemiplimab will be administered as an IV infusion at a dose of 350 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1340

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

OncoResponse, Inc.Lead Sponsor

1 Previous Clinical Trials

172 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has this trial been implemented in clinical settings?

"Currently, there are 4 active research sites for this trial: NEXT Dallas in Irving, NEXT Oncology in San Antonio, and NEXT Virginia in Fairfax; with additional locations yet to be announced."

Answered by AI

Are there still spaces for prospective participants in the trial?

"Clinicaltrials.gov reveals that this trial is actively recruiting participants; the initial post was on October 24th 2023, and the record was most recently updated on October 31st of the same year."

Answered by AI

How large is the cohort of individuals involved in this research experiment?

"Affirmative. Records available on clinicaltrials.gov suggest that this trial, which was first listed on October 24th 2023 is still actively recruiting participants. It will involve 168 patients from 4 different medical locations."

Answered by AI

What are the primary goals that this trial is aiming to achieve?

"The primary objective of the evaluation period, which spans from screening to 90 days after the last dose, is to measure Dose-limiting Toxicity. Secondary outcomes such as Objective Response Rate (ORR), Disease Control Rate (DCR) and Progression Free Survival (PFS) will also be calculated according to RECIST v1.1 criteria for ORR, percentage of subjects with a complete response or partial response/stable disease over two consecutive tumor assessments for DCR and time between initiation of study therapy and date measurement criterias are first met for PD or death from any cause for PFS respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents

2023. "A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06090266.