A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
OncoResponse, Inc.
Study ID
NCT05094804
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • OR2805 — DRUG
    IgG1 monoclonal antibody that binds specifically to the CD163 protein.
  • Cemiplimab — DRUG
    IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.
  • Docetaxel — DRUG
    An antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions.

Study Details

This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR2805 administered as a monotherapy and in combination with anti-cancer agents in subjects with advanced solid tumors.

Key Dates

Start date
Sep 9, 2021
Status verified
Oct 2023
Primary completion
Apr 15, 2024
Completion
Aug 15, 2024

Study Design

Enrollment
172 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: OR2805 monotherapy and combination therapy dose-escalation phase (Part A)
    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.
  • Experimental: OR2805 monotherapy and combination therapy dose-expansion phase (Part B)
    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.
  • Experimental: OR2805 biological effects phase (Part C)
    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.

Primary Outcome Measure

Dose-limiting Toxicity [ Time Frame: First 21 days of treatment. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Michael S Gordon, MD
[email protected]
480-323-1350
NEXT AustinAustinTexas78758
Andrae Vandross, MD
[email protected]
210-580-9500
NEXT OncologySan AntonioTexas78229
Anthony W Tolcer, MD
[email protected]
210-580-9500

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By research site
HonorHealth Research Institute· Scottsdale, AZNEXT Austin· Austin, TXNEXT Oncology· San Antonio, TX

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