ORB-011 In Patients With Advanced Solid Tumors

NCT05947474 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OR1-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Cancer

Keywords

solid tumors

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events (AE) in patients dosed with ORB-011

  Number of participants with adverse events (AE) in patients dosed with ORB-011

  12 months

• Determine Recommended Phase 2 Dose (RP2D)

  Identify a RP2D for future studies.

  12 months

Secondary Outcomes (2)

• Measure Maximum Plasma Concentration [Cmax]).

  12 months

• Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-001

  12 months

Study Arms (1)

Dose Escalation ORB-011

EXPERIMENTAL

ORB-011 Dose Escalation Participants will be administered study drug at dose levels corresponding to their Cohort. Cohort 1 will be treated with the lowest dose, and the dose will be escalated for future cohorts once the previous dose has been observed not to be associated with DLTs. Up to 7 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates.

Drug: ORB-011

Interventions

ORB-011 DRUG

Drug: ORB-011 is dosed via IV infusion

Dose Escalation ORB-011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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.
• Must have received or be ineligible for all standard of care therapies as deemed appropriate by the treating physician.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• 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)
• 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.

You may not qualify if:

• Patients are to be excluded from the study if they meet any of the following criteria:
• Patients who are receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ORB-011 or its excipients.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because the effects of ORB-011 on a pregnant woman or fetus are unknown. Breastfeeding should be discontinued as the potential risk for AEs in nursing infants treated with ORB-011 is unknown.
• Patients with hydronephrosis, except for those patients where hydronephrosis has been longstanding (ie, predates the diagnosis of the CIS, Ta, or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor causing the hydronephrosis
• Any other anticancer therapy (eg, chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy, investigational agent) within 28 days or 5 half-lives (whichever is shorter) of the study treatment
• The patient has a diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer, localized prostate cancer on active surveillance, or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy in the next 2 years
• Current or prior use of immunosuppressive medication within 28 days before ORB-011 treatment with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg. colitis or Crohn s disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism stable on hormonal replacement
• Patients without active disease in the last 5 years may be included
• Patients with celiac disease controlled by diet alone
• History of primary immunodeficiency

Sponsors & Collaborators

• Orionis Biosciences Inc: lead

Study Sites (2)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

MD Anderson Center

Houston, Texas, 77030, United States

Location

Study Officials

• Robert Petit, PhD

  SVP Early Clinical Development

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 17, 2023
• Study Start: August 21, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)