ORB-021 In Patients With Advanced Solid Tumors

NCT06607939 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: ORB-021IND#167998
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Solid Tumors Cancer

Keywords

cancer; solid tumors; adults

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events (AE) in patients dosed with ORB-021 Number of participants with adverse events (AE) in patients dosed with ORB-011

  Number of participants with adverse events (AE) in patients dosed with ORB-021

  12 months

Secondary Outcomes (1)

• Determine Recommended Phase 2 Dose (RP2D)

  12 months

Other Outcomes (1)

• Collect the number of Dose Limiting Toxicities (DLTs) in patients dosed with ORB-021

  12 months

Study Arms (1)

Experimental: Dose Escalation ORB-021

EXPERIMENTAL

ORB-012 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 5 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates.

Drug: ORB-021

Interventions

ORB-021 DRUG

ORB-021 is dosed via IV infusion

Experimental: Dose Escalation ORB-021

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 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 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)
• 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.
• Ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent document.

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-021 or its excipients.
• 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.
• Patients with unresolved symptomatic 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
• Patients with primary malignant brain tumors, untreated and/or unresolved or symptomatic brain metastasis
• 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.
• 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
• History of primary immunodeficiency

Sponsors & Collaborators

• Orionis Biosciences Inc: lead

Study Sites (2)

Honor Health Clinical Research

Scottsdale, Arizona, 85258, United States

RECRUITING

MDAC

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Robert Petit, PhD

  Orionis Biosciences

  STUDY CHAIR

Central Study Contacts

Jennifer Hertzog, PhD

CONTACT

617-204-8836; jhertzog@orionisbio.com

Azza Gadir, PhD

CONTACT

agadir@orionisbio.com

Study Design

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

Model Details: Experimental: Dose Escalation ORB-021 ORB-021 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 5 dose cohorts have been pre-specified. Doses from the escalation arms will be selected as RP2D candidates. Drug: ORB-021 is dosed via IV infusion

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)