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ORB-011 In Patients With Advanced Solid Tumors (ORB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05947474
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : September 13, 2023
Information provided by (Responsible Party):
Orionis Biosciences Inc

Tracking Information
First Submitted Date  ICMJE June 7, 2023
First Posted Date  ICMJE July 17, 2023
Last Update Posted Date September 13, 2023
Actual Study Start Date  ICMJE August 1, 2023
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2023)
  • Number of Adverse Events (AE) in patients dosed with ORB-011 [ Time Frame: 12 months ]
    Number of participants with adverse events (AE) in patients dosed with ORB-011
  • Determine Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]
    Identify a RP2D for future studies.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2023)
  • Measure Maximum Plasma Concentration [Cmax]). [ Time Frame: 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 [ Time Frame: 12 months ]
    Record the number of DLTs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE ORB-011 In Patients With Advanced Solid Tumors
Official Title  ICMJE ORB-011 In Patients With Advanced 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Cancer
Intervention  ICMJE Drug: ORB-011
Drug: ORB-011 is dosed via IV infusion
Study Arms  ICMJE Experimental: Dose Escalation ORB-011
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.
Intervention: Drug: ORB-011
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2023)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • Exclusion Criteria:

Patients are to be excluded from the study if they meet any of the following criteria:

  1. Patients who are receiving any other investigational agents
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ORB-011 or its excipients.
  3. 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.

    Urinary tract infections (UTIs) are excluded from being an exclusion criterion for treatment unless they are Grade 3 or higher.

  4. 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.
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. History of primary immunodeficiency
  11. History of allogeneic organ transplant
  12. History of hypersensitivity to interferon alpha 2b or any excipient
  13. Active infection with:

    • Tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and PPD testing if indicated),
    • Hepatitis B (HBV) or hepatitis C Virus (HBC): Patients with active HBV infection or active HCV infection are ineligible. However, patients with a history of HBV infection who have undetectable or low levels of HBV DNA and normal ALT are eligible. Patients with chronic HBV infection who meet the criteria for anti-HBV therapy are eligible if they have initiated anti-HBV therapy prior to treatment with ORB-011.

    Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and have a viral load that is below the limit of detection.

    • HIV: Patients living with HIV infection are ineligible only if they have a CD4 count less than 350 cells/µL and a history of an AIDS-defining infection within the last 12 months. Patients with a CD4 count greater than 350 cells/µL or who have not had an AIDS-defining infection within the last 12 months are eligible. Eligible patients living with HIV should maintain effective anti-retroviral therapy.
    • SARS-COV2 (PCR positive)
  14. Receipt of live attenuated vaccination within 28 days prior to the study treatment
  15. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
  16. Patients with uncontrolled seizures
  17. Any unresolved toxicity National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
  18. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ORB-011 may be included only after consultation with the Principal Investigator
  19. Patients with QTcF > 480 ms
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Hertzog, PhD 6172038836
Contact: Azza Gadir, PhD
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05947474
Other Study ID Numbers  ICMJE OR1-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Orionis Biosciences Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Orionis Biosciences Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert Petit, PhD SVP Early Clinical Development
PRS Account Orionis Biosciences Inc
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP