Advanced Solid Cancer
Conditions
Keywords
solid tumors
Brief summary
The goal of this clinical research study is to determine if an investigational new drug, named ORB-011, developed by Orionis Biosciences is safe and can be tolerated in people diagnosed with an advanced solid tumor. The study also aims to find the biologically optimal dose of the study medicine by assessing the safety and potential activity in the treatment of solid tumors. There are three phases to this study: screening, treatment and end of treatment.
Detailed description
ORB-011 is a complex engineered biologic molecule that targets interferon alpha 2b activation specifically to type 1 conventional dendritic cells (cDC1). The interferon alpha 2b in ORB-011 is inactive to all other cell types but confers full activation in cis when bound to cDC1 cells which exclusively express CLEC9a, thereby eliminating the potential systemic toxicities caused by alpha interferon when binding to interferon receptors on other cells. ORB-1 is administered by intravenous (IV) infusion. In cancer patients, treatment may be repeated every 3 weeks.
Interventions
DRUGORB-011
Drug: ORB-011 is dosed via IV infusion
Sponsors
Orionis Biosciences Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients must meet the following criteria for inclusion: 1. Age 18 years or older 2. Patients with evidence of recurrent or refractory colorectal, HR+, triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), pancreatic cancer, head and neck squamous cell carcinoma (HNSCC), or metastatic melanoma, bladder/urothelial, gastric, esophageal, renal cell, hepatic, ovarian or other solid tumors deemed medically safe to undergo serial biopsies. 3. Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. Adequate organ and marrow function as defined below: * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L (\> 1500 per mm3 * Platelet count ≥ 75 × 109 /L (\> 75,000 per mm\^3) * Serum bilirubin less than or equal to 1.5 × institutional upper limit of normal (ULN). * AST (SGOT)/ALT (SGPT) less than or equal to 2.5 × institutional ULN * Creatinine clearance (CL) \> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) * Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 3 days prior to treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause) 6. Patients and their partners must practice approved forms of contraception. Sexually active WCBP must agree to use a highly effective method of contraception prior to study entry and continuing for 30 days after ORB-011 administration. Highly effective methods of contraception are highly effective birth control methods with a failure rate of \< 1% per year when used consistently and correctly. Additionally, male patients should refrain from donating sperm for 3 months following the last dose of study drug. 7. Ability to understand and willingness to sign an Institutional Review Board (IRB)- approved written informed consent document (or that of legally authorized representative, if applicable)
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AE) in patients dosed with ORB-011 | 12 months | Number of participants with adverse events (AE) in patients dosed with ORB-011 |
| Determine Recommended Phase 2 Dose (RP2D) | 12 months | Identify a RP2D for future studies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Maximum Plasma Concentration [Cmax]). | 12 months | Measure Maximum Plasma Concentration \[Cmax\]) of ORB-011 in patients |
| Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-001 | 12 months | Record the number of DLTs |
Countries
United States
Contacts
STUDY_CHAIRRobert Petit, PhD
SVP Early Clinical Development
Outcome results
None listed