Actively Recruiting
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
Led by BioEclipse Therapeutics · Updated on 2024-02-08
60
Participants Needed
3
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of consent
- Able to provide written informed consent
- Histologically confirmed diagnosis of triple negative breast cancer, colorectal cancer, hepatocellular carcinoma, osteosarcoma, epithelial ovarian cancer, malignant melanoma, non-small cell lung cancer, or gastric cancer
- Disease that has relapsed or is refractory after prior standard treatments, or no expected benefit from these treatments
- Ovarian cancer patients must have received at least one prior platinum-based treatment
- Agree to provide fresh tumor tissue or archival tumor tissue if biopsy is unsafe
- Have measurable disease by CT or MRI with IV contrast
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks from enrollment
- Adequate blood counts and organ function as defined in the protocol
- Negative pregnancy test for women of childbearing potential
- Agree to use effective contraception methods during and six months after treatment
- Willing and able to comply with all study procedures and follow-up
You will not qualify if you...
- New or progressive brain metastases; stable treated brain metastases allowed if no progression for at least 4 weeks
- Received chemotherapy, immunotherapy, radiotherapy, radiosurgery, or investigational agents within 3 weeks prior to enrollment
- Ongoing Grade 2 or higher side effects from prior therapies unless approved
- Received cell-based therapies within 12 weeks prior to planned leukapheresis
- Active infections requiring systemic antimicrobial treatment
- History or evidence of active or symptomatic autoimmune disease requiring systemic treatment in the past 2 years, with some exceptions
- Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive drugs within 14 days prior to leukapheresis and infusion
- Known HIV infection, active chronic hepatitis B or C, or serious unrelated medical or psychiatric illnesses
- Pregnant or nursing women
- Clinically significant immunodeficiency in subject or household contacts
- Other medical or psychiatric conditions that could interfere with study participation
- History of another invasive cancer unless disease-free for at least 2 years or low risk of recurrence, with some cancer exceptions
AI-Screening
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Trial Site Locations
Total: 3 locations
1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
J
Jennifer Lindal
CONTACT
P
Pamela Contag, PhD Chief Executive Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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