Actively Recruiting
A Phase 1/2 Study of OR502 Alone and in Combination With Other Anti-cancer Agents in Subjects With Advanced Malignancies
Led by OncoResponse, Inc. · Updated on 2025-01-07
168
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating OR502, a monoclonal antibody targeting LILRB2, alone and in combination with cemiplimab in people with advanced solid tumors. This open-label, early-phase study aims to assess the safety, tolerability, how the body processes the drugs, and preliminary anti-tumor effects in adults with various advanced cancers. The study is part of a Phase 1-2 trial involving multiple centers and includes patients with different tumor types, including ovarian cancer, cutaneous squamous cell carcinoma, melanoma, and non-small cell lung cancer. The study has several parts: Part A involves dose escalation of OR502 alone or combined with cemiplimab, both given intravenously every three weeks, to find the optimal dose. Part B includes expansion cohorts where participants receive OR502 at two dose levels as monotherapy or with cemiplimab, targeting specific cancers such as platinum-resistant ovarian cancer and cutaneous squamous cell carcinoma. Additional mini-expansion cohorts treat melanoma and non-small cell lung cancer patients who previously received PD-(L)1 inhibitor therapies. Cemiplimab is administered as an IV infusion at a fixed dose of 350 mg. Participants will undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, vital signs, and organ function from screening through 90 days post-treatment. Researchers will measure pharmacokinetics, tumor response rates, disease control, and progression-free survival. Tissue biopsies for biomarker analysis may be requested but are optional except for certain cohorts. The total study duration varies by participant, with continuous monitoring during treatment and follow-up phases to evaluate safety and preliminary effectiveness.
CONDITIONS
Brief 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 study procedures.
- Male or female aged 18 years or older.
- Histological diagnosis of carcinoma, sarcoma, or melanoma with progressive metastatic or locally advanced disease not suitable for curative local therapy (Parts A and B1).
- Histological diagnosis of cutaneous squamous cell carcinoma (CSCC) or platinum-resistant ovarian cancer (PROC) with advanced/metastatic disease not suitable for curative local therapy (Parts B2-B3).
- Prior progression on or intolerance to standard systemic anti-cancer therapy or considered ineligible for standard therapy (Part A and B1).
- For mini-expansion cohorts B4 and B5, prior PD-(L)1 inhibitor therapy for at least 12 weeks.
- Measurable disease per RECIST v1.1.
- Willingness to use effective birth control if of childbearing potential.
- Resolution of prior significant therapy-related adverse events to grade 1 or less.
- Minimum 2 weeks since last hormone therapy dose and 3 weeks since last systemic cancer therapy or radiotherapy.
- Adequate organ function.
- Ability to provide archival tumor tissue or consent to biopsy.
- Ability and willingness to comply with study protocol.
- Affiliation with social security or similar scheme as required by local law.
You will not qualify if you...
- History of severe allergic reaction to monoclonal antibodies.
- 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 clinically stable and off steroids.
- History of other malignant tumors unless disease-free for specified periods.
- Recent or uncontrolled serious infections including HIV, hepatitis B or C, or tuberculosis.
- Autoimmune or inflammatory disorders requiring systemic therapy, except certain exceptions.
- Recent use of systemic corticosteroids or immunosuppressive drugs except allowed doses.
- QTc interval 470 msec or higher by ECG.
- Recent use of investigational products or live vaccines.
- Known hypersensitivity or contraindications to cemiplimab for certain cohorts.
- Interstitial lung disease or prior severe pneumonitis.
- Concurrent anti-cancer therapies except allowed hormonal therapy.
- Medical or surgical conditions that could interfere with study or increase risk.
- Recent history of chronic substance abuse.
- Pregnancy, breastfeeding, or planning to conceive during the study.
- Vulnerable persons unable to provide informed consent or under legal protection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive OR502 alone or in combination with cemiplimab through intravenous infusions every 3 weeks to treat advanced solid tumors.
Infusions every 3 weeks with additional visits for safety and assessment
Duration - Up to 90 days after the last dose
Participants are monitored for safety and treatment effects after the last dose of study drugs.
Approximately 3 visits during follow-up period
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
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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