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Official title A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents
ClinicalTrials.gov ID: NCT06090266
What this study is testing
What is OR502?
OR502 is an investigational medicine, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed consent signed by the subject prior to conducting study-specific procedures.
- Male or female people ≥ 18 years of age.
- Histological diagnosis as follows:
- Parts A and B (Cohorts A1, A2, and B1): people must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive...
- Part B (Expansion Cohorts B2-B3): people must have a histological diagnosis of the relevant tumor type (CSCC or PROC) with advanced/metastatic...
You likely can't join if
- Subject previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
- Life expectancy \< 12 weeks.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \> 2.
- Prior organ or stem cell transplant.
- people with symptomatic ascites or pleural effusion. people who are clinically stable for at least 2 weeks following treatment for these conditions...
- Subject has a known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis. people with previously treated...
See the full eligibility criteria
Who can join
- Informed consent signed by the subject prior to conducting study-specific procedures.
- Male or female people ≥ 18 years of age.
- Histological diagnosis as follows:
- Parts A and B (Cohorts A1, A2, and B1): people must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable...
- Part B (Expansion Cohorts B2-B3): people 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.
- Prior therapies: a. Part A (dose-escalation) and Cohort B1 (monotherapy expansion) i. people must have experienced progressive disease (PD) on an established standard systemic anti-cancer therapy for a given tumor type...
- people must have measurable disease per RECIST v1.1.
- People of childbearing potential, if not postmenopausal (defined as no menses for at least 12 continuous months prior to study entry) or surgically sterile, must be willing to practice at least one of the highly...
- Resolution of prior clinically significant therapy-related AEs (excluding alopecia and ≤ Grade 2 peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0, and no treatment for these AEs for at least 2 weeks prior...
- Minimum of 2 weeks since the last dose of other hormone therapy and 3 weeks since the last dose of other systemic cancer therapy or radiotherapy (\> 4 weeks in case of nitrosoureas or radio-immuno conjugate therapy)...
- people must have adequate organ function.
- Biopsy specimens:
- All people must be able to supply an archival tumor tissue specimen. If an archival specimen is not available, people may remain eligible with approval of the medical monitor.
- people in Cohort B1 must consent to pre- and on-treatment biopsies. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time...
- people in all other cohorts will be asked to consent to pre- and on-treatment biopsies for biomarker analysis of the acquired tissue. These biopsies are optional and not required for study participation. Tissue obtained...
- Subject is able and willing to comply with the protocol and the restrictions and assessments therein.
- As required by local regulations or law, people must fulfill the obligation of affiliation or beneficiary of a social security or similar scheme.
What rules you out
- Subject previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
- Life expectancy \< 12 weeks.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \> 2.
- Prior organ or stem cell transplant.
- people with symptomatic ascites or pleural effusion. people who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) are eligible.
- Subject has a known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis. people with previously treated brain metastases may participate provided they are clinically stable...
- Subject has a known history of a hematologic malignancy, malignant primary brain tumor, or another malignant primary solid tumor (other than that under study), unless the subject has undergone potentially curative...
- people with a known history of AJCC Stage 1 cancer that has undergone potentially curative therapy with no evidence of recurrent disease for at least 1 year before the start of treatment may be eligible at the...
- people who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers at any time...
- Recent or ongoing serious infection including the following:
- Any uncontrolled Grade 3 or higher (per NCI-CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of OR502. Routine antimicrobial prophylaxis is allowed.
- Uncontrolled infection with human immunodeficiency virus (HIV). people on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry...
- Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. people who are or have received anti-HBV therapy and have undetectable...
- Known active hepatitis C as determined by positive serology and confirmed by polymerase chain reaction (PCR). people on or having received anti-retroviral therapy are eligible provided they are virus-free by PCR for at...
- Known active or latent tuberculosis (testing at screening is not required).
- Autoimmune disease or inflammatory condition requiring systemic anti-inflammatory therapy with exceptions as noted in Exclusion Criterion 10. people on hormone replacement therapy for autoimmune-induced endocrinopathies...
- Use of systemic corticosteroids within 15 days or other immunosuppressive drugs within 30 days prior to start of the study, with the exception of corticosteroids as replacement therapy up to an equivalent of prednisone...
- QTc interval ≥ 470 msec by electrocardiogram (ECG).
- Subject has received an investigational product or been treated with an investigational device within 30 days prior to first administration of study medication.
- Subject has received a live vaccine within 30 days prior to first administration of study medication.
- For Cohorts A2, B1, B2, and B3 only:
- Known hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling.
- Interstitial lung disease.
- Prior pneumonitis requiring systemic corticosteroid therapy.
- Receiving immunosuppressive therapy, with exceptions as noted in Exclusion Criterion 10.
- A history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (\> 10 mg/day prednisone or equivalent) for...
- Concurrent therapy with anti-cancer or anti-neoplastic drugs, with the exception of adjuvant hormonal therapy, which is allowed as outlined in Inclusion Criterion 8.
- History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive...
- people who, at the time of signing informed consent, had a recent history (within the last year) of chronic substance abuse.
- Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study.
- Vulnerable persons: people under judicial safeguard, people deprived of their liberty by judicial or administrative decision, people under psychiatric care without their consent, people admitted to a health or social...
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States; Irving, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.