Study of CRX100 in Patients With Advanced Solid Tumors


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Trial ID: NCT04282044,37


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.

Official Title

A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors

Stanford Investigator(s)

Oliver Dorigo, M.D., Ph.D.
Oliver Dorigo, M.D., Ph.D.

Professor of Obstetrics and Gynecology (Oncology)


Inclusion Criteria:

Subjects must meet all of the following criteria to be enrolled in this study:

   1. Age ≥18 years at the time of consent.

   2. Written informed consent in accordance with national, local, and institutional
   guidelines obtained prior to any study procedures.

   3. 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.

   4. Subjects must have relapsed disease or be refractory or intolerant to standard care,
   or refusing standard therapies.

   5. 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.

   6. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of

   7. Subjects must have recovered from the effects of recent surgery, radiation therapy, or

   8. Subjects must be free of active infections requiring treatment doses of antibiotics,
   antifungals, or antiviral medications.

   9. No cellular therapy to be administered for at least 12 weeks prior to apheresis.

10. 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

11. Adequate organ function, defined as:

      1. Renal function: serum creatinine <1.5x institutional upper limit of normal (ULN)
      or calculated creatinine clearance >50 mL/min

      2. 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.

12. Women of childbearing potential (defined as all women physiologically capable of
   becoming pregnant) must have negative serum ß-human chorionic gonadotropin (ß-HCG) or
   urine pregnancy test.

13. 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.

14. 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.

15. 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

   1. 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
   examination and brain imaging (MRI or CT) during the screening period.

   2. 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.

   3. 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.

   4. 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.

   5. Pregnant or nursing an infant (subject or household contacts).

   6. Clinically significant immunodeficiency (e.g., due to underlying illness and/or
   medication) in a subject or household contacts.

   7. 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.

   8. 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.

   9. Treatment with any investigational drug study, oncolytic viral therapy or
   immunotherapy within three (3) weeks of enrollment.

10. Chemotherapy three (3) weeks prior to infusion.


biological: CRX100 suspension for infusion


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Bela A Shah
(650) 723-0594

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