Actively Recruiting
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
Led by OncoResponse, Inc. · Updated on 2025-01-07
168
Participants Needed
4
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Male or female aged 18 years or older
- Histological diagnosis of carcinoma, sarcoma, melanoma with progressive metastatic or locally advanced disease not curable by local therapy for Parts A and B1
- Histological diagnosis of cutaneous squamous cell carcinoma or platinum-resistant ovarian cancer with advanced/metastatic disease for expansion cohorts B2-B3
- Prior anti-cancer therapy showing progression or intolerance, or no available proven therapies for Parts A and B1
- Prior PD-(L)1 inhibitor therapy for mini-expansion cohorts B4 (melanoma) and B5 (non-small cell lung cancer), with clinical benefit on prior immunotherapy
- For cohort B2, prior PD-(L)1 inhibitor therapy without additional immunotherapy
- For cohort B3, prior platinum-based therapy with progression within 6 months; prior anti-PD-1 therapy allowed
- Measurable disease by RECIST v1.1
- Use of effective birth control if of childbearing potential
- Resolution of prior significant therapy-related adverse events to Grade 1 or less
- Minimum washout periods after prior therapies (2 weeks for hormone therapy, 3 weeks for other systemic or radiation therapies)
- Adequate organ function
- Ability to provide archival tumor tissue or approval for lack thereof
- Consent for biopsies in certain cohorts (optional for some)
- Ability and willingness to comply with study protocol and assessments
- Affiliation to social security or similar as required by local law
You will not qualify if you...
- History of severe hypersensitivity to monoclonal antibody treatments
- Life expectancy less than 12 weeks
- ECOG performance status greater than 2
- Prior organ or stem cell transplant
- Symptomatic ascites or pleural effusion unless stable for at least 2 weeks
- Active central nervous system tumors or metastases unless stable and off steroids
- History of hematologic malignancy, primary brain tumor, or other malignancies unless disease-free for specified durations
- Uncontrolled or recent serious infections including viral, bacterial, fungal, HIV without stable treatment, active hepatitis B or C, or tuberculosis
- Autoimmune or inflammatory conditions requiring systemic anti-inflammatory therapy except specified exceptions
- Recent use of systemic corticosteroids or immunosuppressive drugs except permitted replacements
- QTc interval of 470 msec or greater
- Receipt of investigational products or live vaccines within 30 days prior to study
- For certain cohorts, hypersensitivity to cemiplimab, interstitial lung disease, prior severe pneumonitis, or severe immune-related adverse reactions to ipilimumab
- Concurrent anti-cancer therapies except allowed hormonal therapies
- Medical or surgical conditions that may interfere with study or pose risk
- Recent history of chronic substance abuse
- Pregnancy, breastfeeding, or expectation to conceive or father children during study
- Vulnerable persons unable to consent or under specific legal protections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
NEXT Austin
Austin, Texas, United States, 78758
Actively Recruiting
2
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
4
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
L
Lesley Skingley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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