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ADG126, ADG126 in Combination With Anti PD1 Antibody, and ADG126 in Combination With ADG106 in Advanced/Metastatic Solid Tumors

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Brief Summary

ADG126, ADG126 in Combination with anti-PD1 antibody, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors .

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Adults ≥18 years of age
  • ECOG performance status ≤1
  • Estimated life expectancy of more than 12 weeks
  • Patients with advanced or metastatic solid tumors, confirmed by histologically or pathologically documented (except patients with HCC, please see below for HCC requirement), who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented
  • At least one measurable lesion at baseline per RECIST version 1.1
  • Adequate organ function as defined by the following criteria:
    • ANC ≥1000 cells/μL
    • Platelet count ≥100,000/μL
    • Hemoglobin ≥9.0 g/dL
    • Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases).
    • Total serum bilirubin ≤1.5 x ULN (the following may be an exception - patients with unconjugated hyperbilirubinemia due to underlying Gilbert's Syndrome or familial benign unconjugated hyperbilirubinemia)
    • Serum creatinine ≤2 x ULN or creatinine clearance of ≥45 mL/min.
  • INR and activated partial thromboplastin time (aPTT) ≤1.5 x ULN; patients on full-dose oral anticoagulation must be on a stable dose (minimum duration 14 days); if receiving warfarin, the patient must have an INR ≤3.0 and no active bleeding (i.e., no bleeding within 14 days prior to first dose of study drug); patients on low molecular weight heparin will be allowed.
  • Willing to complete all scheduled visits and assessments at the institution administering therapy
  • Able to read, understand and provide written informed consent

Exclusion Criteria:

  • Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, radiation, or immunotherapy, etc.) within 4 weeks prior to first dose of study drug(s), with the following exceptions:
    • Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer
    • Hormone replacement therapy or oral contraceptives
    • Palliative radiotherapy for bone metastases or other non-target lesions ≥2 weeks prior to first dose of study drug(s)
  • Major trauma or major surgery within 4 weeks prior to first dose of study drug(s)
  • AEs from prior anticancer therapy that have not resolved to Grade ≤1 (except for alopecia) or irAE of immunotherapy resulting in permanent discontinuation, prior Grade 2 pneumonitis or any life-threatening Grade 4 irAE from prior anticancer therapy
  • Central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to the first dose of study drug(s)that are clinically stable and do not require chronic corticosteroid treatment to be enrolled in the study), or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity .
  • Any evidence of underlying liver decompensation due to other causes, such as history of significant alcohol abuse, alcoholic or drug-induced hepatitis, or documented F4 non alcoholic steatohepatitis.
  • Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation
  • Clinically significant cardiac disease, such as:
    • New York Heart Association Class III IV cardiac disease, including pre-existing clinically significant ventricular arrhythmia, congestive heart failure or cardiomyopathy
    • Unstable angina pectoris ≤6 months prior to Cycle 1 Day 1
    • Acute myocardial infarction ≤6 months prior to Cycle 1 Day 1
    • Other clinically significant heart disease (eg, Grade ≥3 uncontrolled hypertension or history of poor compliance with an antihypertensive regimen)
    • Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy
    • Significant ECG abnormalities including QTc interval >470 msec, 2nd degree (type II) or 3rd degree atrioventricular (AV) block
  • Evidence of active uncontrolled viral, bacterial, or systemic fungal infection defined as requiring use of systemic antimicrobials within 2 weeks of Cycle 1 Day 1; prophylactic therapy according to institutional protocols is acceptable
  • Patients who received:
    • A COVID-19 vaccine within 7 days of Cycle 1 Day 1.
    • Live vaccines or live-attenuated vaccines within 28 days prior Cycle 1 Day 1.
  • Known positive test result for human immunodeficiency virus (HIV) (unless the disease is clinically controlled) or acquired immune deficiency syndrome (AIDS)
  • Patients who have immunosuppressive medications or immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) within 28 days prior to Cycle 1 Day 1.However, patients who received a short course of corticosteroids (eg, premedication prior to a contrast computed tomography [CT]) will be eligible for study entry
  • Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following:
    • The diseases are clinically controlled
    • Patients with anti-hepatitis B core antibody but with undetectable HBV DNA and negative for surface antigen of HBV
    • Patients with resolved or treated HCV (i.e., HCV antibody positive but undetectable HCV RNA) in the study
  • Second primary malignancy not in remission for greater than 3 years; exceptions that do not require a 3-year remission include: non-melanoma skin cancer, cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear, localized prostate cancer (Gleason score <6), or resected melanoma in situ; other localized, solid tumors in situ or other low risk cancers may also be exempt after discussion with the Sponsor medical monitor
  • History (within the last 5 years) or risk of autoimmune disease (eg, autoimmune thyroid disease, Bell's palsy, glomerulonephritis, Guillain-Barré syndrome, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, Sjögren's syndrome, systemic lupus erythematosus, vascular thrombosis associated with antiphospholipid syndrome, vasculitis, or Wegener's granulomatosis)
  • Any serious underlying medical (eg, pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition (eg, alcohol or drug abuse, dementia or altered mental status) or any issue that would limit compliance with study requirements, impair the ability of the patient to understand informed consent, or that in the opinion of the investigator would contraindicate the patient's participation in the study or confound the results of the study
  • Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG126, ADG106 and toripalimab (see Investigator's Brochure and Toripalimab Product Insert)
  • Pregnant, lactating, or breastfeeding females
  • Females of childbearing potential who either have a positive pregnancy test before enrollment or who do not agree to use 2 highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom; intrauterine device and condom; diaphragm with spermicidal gel and condom) during the trial and for 90 days after the last dose of the study drug
  • Male patients (with female pregnant or lactating partners or of childbearing potential) who do not agree to using one form of highly effective contraception [condom plus spermicide] during the trial and for 90 days after the last dose of the study drug
  • Participation or plans to participate in another interventional clinical study while taking part in this protocol.
  • Has received a positive COVID-19 test result within 14 days of Cycle 1 Day 1

Join this Trial

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Study Stats
Protocol No.
22-000305
Category
Hematology-Oncology
Oncology
Contact
Elizabeth Seja
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04645069
For detailed technical eligibility, visit ClinicalTrials.gov.