RECRUITING

ORB-021 In Patients With Advanced Solid Tumors

Conditions

Advanced Solid Tumors Cancer cancer solid tumors adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical research study is to determine if an investigational new drug, named ORB-021, 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.

Official Title

ORB-021 In Patients With Advanced Solid Tumors

Quick Facts

Study Start:2024-11-21

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06607939

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older 2. Patients with evidence of recurrent or refractory 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 for patients without known liver metastases and up to 5 x institutional ULN for patients with known liver metastases. * 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-021 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.	* 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-021 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-021 on a pregnant woman or fetus are unknown. Breastfeeding should be discontinued as the potential risk for AEs in nursing infants treated with ORB-021 is unknown. 5. Patients with unresolved symptomatic 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. Patients with primary malignant brain tumors, untreated and/or unresolved or symptomatic brain metastasis 9. Current or prior use of immunosuppressive medication within 28 days before ORB-021 treatment with the exceptions of ophthalmic, intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. 10. Active or prior documented autoimmune or inflammatory disorders requiring systemic immunosuppressive medications (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 11. History of primary immunodeficiency 12. History of allogeneic organ transplant 13. History of hypersensitivity to interferon alpha 2b or any excipient 14. 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-021. 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) 15. Receipt of live attenuated vaccination within 28 days prior to the study treatment 16. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. 17. Patients with uncontrolled seizures 18. 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, endocrinopathies, and the laboratory values defined in the inclusion criteria. 19. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ORB-021 may be included only after consultation with the Principal Investigator 20. Patients with QTcF \> 480 ms 21. Patients with prior grade 3 irAE or any irAE that resulted in discontinuation of PD-1 or PD-L1 ICI treatment.

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older
2. Patients with evidence of recurrent or refractory 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 for patients without known liver metastases and up to 5 x institutional ULN for patients with known liver metastases.
* 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-021 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.

* 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-021 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-021 on a pregnant woman or fetus are unknown. Breastfeeding should be discontinued as the potential risk for AEs in nursing infants treated with ORB-021 is unknown.
5. Patients with unresolved symptomatic 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. Patients with primary malignant brain tumors, untreated and/or unresolved or symptomatic brain metastasis
9. Current or prior use of immunosuppressive medication within 28 days before ORB-021 treatment with the exceptions of ophthalmic, intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
10. Active or prior documented autoimmune or inflammatory disorders requiring systemic immunosuppressive medications (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
11. History of primary immunodeficiency
12. History of allogeneic organ transplant
13. History of hypersensitivity to interferon alpha 2b or any excipient
14. 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-021. 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)
15. Receipt of live attenuated vaccination within 28 days prior to the study treatment
16. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
17. Patients with uncontrolled seizures
18. 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, endocrinopathies, and the laboratory values defined in the inclusion criteria.
19. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with ORB-021 may be included only after consultation with the Principal Investigator
20. Patients with QTcF \> 480 ms
21. Patients with prior grade 3 irAE or any irAE that resulted in discontinuation of PD-1 or PD-L1 ICI treatment.

Contacts and Locations

Study Contact

Jennifer Hertzog, PhD

CONTACT

617-204-8836

jhertzog@orionisbio.com

Azza Gadir, PhD

CONTACT

agadir@orionisbio.com

Principal Investigator

Robert Petit, PhD

STUDY_CHAIR

Orionis Biosciences

Study Locations (Sites)

Honor Health Clinical Research

Scottsdale, Arizona, 85258

United States

MDAC

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Orionis Biosciences Inc

Robert Petit, PhD, STUDY_CHAIR, Orionis Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

cancer
solid tumors
adults

Additional Relevant MeSH Terms

Advanced Solid Tumors Cancer