A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies

Who is this study for? Adults with Advanced Solid Tumors
What treatments are being studied? CRX100 Suspension for Infusion
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological, Combination product
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. 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 CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma. The study will start with monotherapy dose escalation followed by combination cohorts.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects must meet all 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. (Screening assessments performed prior to informed consent but within the 28-day screening window are acceptable for inclusion purposes).

• Subjects must have histologically confirmed diagnosis of one of the following tumors: triple negative adenocarcinoma of the breast (human epidermal growth factor receptor 2 negative, estrogen receptor negative and progesterone receptor negative \[HER2-/ER-/PR-\]), adenocarcinoma of the colon or rectum, hepatocellular carcinoma (HCC), osteosarcoma, epithelial ovarian cancer, malignant melanoma, non-small cell lung cancer (NSCLC), or gastric cancer. Documentation of the diagnosis with the original pathology report, or a recent biopsy, is required.

• Subjects must have relapsed disease or refractory disease. Subjects must have received, completed, or become intolerant of prior standard of care therapies or are not expected to derive any clinical benefit from standard of care therapies.

• Subjects with Ovarian cancer must have received at least one prior standard of care for their relapsed or refractory disease, which must include a platinum-based regimen.

• Subjects agree to provide fresh tumor tissue that has not been previously irradiated. If biopsy procedure is not safe to perform, then archival tumor tissue (20 slides or a tissue block) can be submitted.

• 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 0-1.

• Subjects are expected to have a life expectancy of at least 12 weeks from the time of enrollment.

⁃ 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. For subjects enrolling into the LDC cohorts, the criteria are defined as: ALC\>500 cells/mm3, ANC\>1000 cells/mm3, hemoglobin\>8g/dL, and platelet count\>100,000 cells/mm3.

⁃ a. Hemoglobin and platelet count thresholds must be achievable without transfusion of red blood cells or platelets, or use of growth factors administered within two weeks.

⁃ 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 ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5x institutional ULN, 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 ULN, INR ≤1.7, Child-Turcotte-Pugh score \<8.

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

⁃ Women of childbearing potential must agree to use highly effective methods of contraception throughout the study and for six months after the last dose of CRX100.

⁃ Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method throughout the study and for six months after the last dose of CRX100.

⁃ Subjects must be willing and able to comply with all study procedures, requirements, and follow-up examinations.

Locations
United States
Arizona
HonorHealth Research Institute
RECRUITING
Scottsdale
California
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Stanford University
RECRUITING
Stanford
Contact Information
Primary
Jennifer Lindal
clinical@bioeclipse.com
206-229-5827
Backup
Pamela Contag, PhD Chief Executive Officer
info@bioeclipse.com
Time Frame
Start Date: 2021-01-08
Estimated Completion Date: 2026-10
Participants
Target number of participants: 60
Treatments
Experimental: Monotherapy Dose-Escalation Cohorts
Prior to the current amendment, no DLTs were observed at Dose Levels 1-5. Starting with the current protocol amendment, dosing decisions in monotherapy cohorts will utilize a 3+3 design for Dose Level 6. CRX100 infusion will occur every nine weeks (+/- 7 days). Subjects will receive up to a maximum of four infusions of CRX100 unless it is determined by the treating physician and the sponsor that it is in the best interest of the subjects to receive additional doses of CRX100 beyond four doses. A minimum of three DLT-evaluable subjects will be doses at Dose Level 6 and expanded to six subjects if determined necessary based on DLT incidence using the 3+3 design, and discussion with SRC and Sponsor.
Experimental: Combination Therapy Cohorts
Subjects with relasped or refractory solid tumors, as defined in the inclusion criteria, will be enrolled to evaluate the safety and anti-tumor activity of CRX100 in combination with Pembrolizumab in patients with advanced solid malignancies. The dose of CRX100 used will be determined from the monotherapy cohorts.~CRX100 infusion will occur every nine weeks (+/- 7 days). Subjects will receive up to a maximum of four doses of CRX100 unless it is determined by the treating physician and the sponsor that it is in the best interest of the subjects to receive additional doses of CRX100 beyond four doses.~Pembrolizumab will be administered at 200mg IV every three weeks (Q3W) per the approved label.
Authors
Sanip Patel, Jasgit C Sachdev
Sponsors
Leads: BioEclipse Therapeutics

This content was sourced from clinicaltrials.gov