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

Part of paid clinical trials in Austin, Texas.

Sponsor
OncoResponse, Inc.
Study ID
NCT06090266
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • OR502 — DRUG
    IgG1 monoclonal antibody that binds specifically to the LILRB2 protein.
  • Cemiplimab — DRUG
    IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.

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 OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.

Key Dates

Start date
Oct 24, 2023
Status verified
Jan 2025
Primary completion
Aug 1, 2026
Completion
Feb 1, 2027

Study Design

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

Arms

  • Experimental: OR502 monotherapy and combination therapy dose-escalation phase (Part A)
    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.
  • Experimental: OR502 monotherapy and combination therapy dose-expansion phase (Part B)
    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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
NEXT AustinAustinTexas78758
Andrae Vandross, MD
[email protected]
737-610-5200
NEXT DallasIrvingTexas75039
Shiraj Sen, MD
[email protected]
972-893-8800
NEXT OncologySan AntonioTexas78229
David Sommerhalder, MD
[email protected]
210-580-9500
NEXT VirginiaFairfaxVirginia22031
Mohamad A Salkeni, MD
[email protected]
703-280-9596

Find similar trials in Austin, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
NEXT Austin· Austin, TXNEXT Dallas· Irving, TXNEXT Oncology· San Antonio, TXNEXT Virginia· Fairfax, VA

Related Studies