Study of CRX100 in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Mar 10, 2025
  • participants needed
    24
  • sponsor
    BioEclipse Therapeutics
Updated on 10 August 2022
platelet count
antibiotics
renal function
gonadotropin
cancer
estrogen
carcinoma
growth factor
MRI
progesterone
kidney function tests
human chorionic gonadotropin
neutrophil count
adenocarcinoma of the colon
epidermal growth factor receptor
HER2
EGFR
human epidermal growth factor
cancer chemotherapy
adenocarcinoma
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor
cellular therapy

Summary

This clinical study is an open-label, phase 1, dose-escalation study to determine the safety, tolerability, and pharmacokinetic (PK) properties of CRX100 in adult subjects with advanced solid tumors. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of autologous cytokine induced killer (CIK) cells. Patients with triple-negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, and gastric cancer will be considered.

Details
Condition Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Osteosarcoma, Epithelial Ovarian Cancer, Gastric Cancer
Treatment CRX100 suspension for infusion
Clinical Study IdentifierNCT04282044
SponsorBioEclipse Therapeutics
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must meet all of the following criteria to be enrolled in this study
Age ≥18 years at the time of consent
Written informed consent in accordance with national, local, and institutional guidelines obtained prior to any study procedures
Subjects must have histologically-confirmed diagnosis of one of the following tumors: triple negative adenocarcinoma of the breast (human epidermal growth factor receptor 2- estrogen receptor- and progesterone receptor- negative [HER2-/ER-/PR-]), adenocarcinoma of the colon or rectum (CRC), hepatocellular carcinoma (HCC), osteosarcoma, epithelial ovarian cancer, or gastric cancer. Documentation of the diagnosis with the original pathology report, or a recent biopsy, is required
Subjects must have relapsed disease or be refractory or intolerant to standard care, or refusing standard therapies
Subjects must have iRECIST evaluable disease using computed tomography (CT) or magnetic resonance imaging (MRI) with IV contrast , with at least one measurable target lesion
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Subjects must have recovered from the effects of recent surgery, radiation therapy, or chemotherapy
Subjects must be free of active infections requiring treatment doses of antibiotics, antifungals, or antiviral medications
No cellular therapy to be administered for at least 12 weeks prior to apheresis
Adequate hematologic function at the time of screening, defined as: absolute lymphocyte count (ALC) >500 cells/mm3, absolute neutrophil count (ANC) >750 cells/mm3, hemoglobin >8 g/dL, and platelet count >50,000 cells/mm3. Hemoglobin and platelet count thresholds must be achievable without transfusion of red blood cells or platelets
Adequate organ function, defined as
Renal function: serum creatinine <1.5x institutional upper limit of normal (ULN) or calculated creatinine clearance >50 mL/min
Adequate hepatic function: total bilirubin ≤1.5x institutional upper limit of normal; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional upper limit of normal, unless liver metastases are present, in which case it must be ≤5x ULN; International Normalized Ratio (INR) ≤1.5. For subjects with HCC, adequate hepatic function is defined as: total bilirubin ≤3x institutional upper limit of normal, AST/ALT ≤5x institutional upper limit of normal, INR ≤1.7, Child-Turcotte-Pugh score <8\
Women of childbearing potential (defined as all women physiologically capable of
becoming pregnant) must have negative serum ß-human chorionic gonadotropin
Women of childbearing potential must agree to use highly effective methods of contraception throughout the study and for 6 months after the last dose of CRX100
(ß-HCG) or urine pregnancy test
Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method throughout the study and for 6 months after the last dose of CRX100
Subjects must be willing to comply with all study procedures, requirements and follow-up examinations

Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from participation in this
study
Subjects with new or progressive brain metastasis. Subjects with treated brain
metastases are eligible if there is no evidence of progression for at least 4 weeks
after central nervous system-directed treatment, as ascertained by clinical
Pregnant or nursing an infant (subject or household contacts)
examination and brain imaging (MRI or CT) during the screening period
Active or history of autoimmune disease (known or suspected). Exceptions are permitted
for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune
condition requiring only hormone replacement, psoriasis not requiring systemic
treatment, or conditions not expected to recur in the absence of an external trigger
Chemotherapy three (3) weeks prior to infusion
Have a condition requiring systemic treatment with either corticosteroids (>10 mg
daily prednisone or equivalent) or other immunosuppressive medications within 14 days
prior to apheresis, and within 14 days prior to infusion. Inhaled or topical steroids
and adrenal replacement doses (≤10 mg daily prednisone equivalents) are permitted in
the absence of active autoimmune disease. Short-term (<48 hr) steroid pretreatment for
contrast allergy for imaging is permitted
Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C
life-threatening illnesses unrelated to cancer, or any serious medical or psychiatric
illness that could, in the Investigator's opinion, interfere with participation in
this study
Clinically significant immunodeficiency (e.g., due to underlying illness and/or
medication) in a subject or household contacts
Have any underlying medical condition (including, but not limited to, ongoing or
active infection requiring treatment, symptomatic congestive heart failure, unstable
angina pectoris, or cardiac arrhythmia), psychiatric condition, or social situation
that, in the opinion of the Investigator, would compromise study administration as per
protocol or compromise the assessment of AEs
Have a history of another invasive malignancy, except for the following circumstance
individuals with a history of invasive malignancy are eligible if they have been
disease free and off treatment for at least 2 years or are deemed by the Investigator
to be at low risk for recurrence of that malignancy; individuals with the following
cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral
cavity, or cervix, localized prostate cancer, or basal cell or squamous cell carcinoma
of the skin. When enrolling a subject with another malignancy, the Investigator should
consider discussing the subject with the Medical Monitor
Treatment with any investigational drug study, oncolytic viral therapy or
immunotherapy within three (3) weeks of enrollment
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