Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
BioEclipse Therapeutics
Study ID
NCT04282044
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRX100 suspension for infusion — BIOLOGICAL
    A fixed dose of CIK cells combined with the specified dose of CDSR.
  • Fludarabine — COMBINATION_PRODUCT
    25mg/m IV (five doses given from Day -7 until Day -3)
  • Cyclophosphamide — COMBINATION_PRODUCT
    60mg/kg intravenous (IV) (two doses given on Day -7 and -6)

Study Details

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.

Key Dates

Start date
Jan 8, 2021
Status verified
Feb 2024
Primary completion
Aug 31, 2025
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities [ Time Frame: 28 days following dose administration for each dosed subject. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
HonorHealth Research InstituteScottsdaleArizona85258
Patricia Shannon
[email protected]
480-323-1364
Justin Moser, MD (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Natalia Ortuno
[email protected]
858-246-2073
Sandip Patel, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityStanfordCalifornia94305
Mary Herrera
[email protected]
650-723-0622
Oliver Dorigo, MD (PRINCIPAL_INVESTIGATOR)

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