Solid Tumor, AdultPhase 1NCT04282044
Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
A Phase 1 study testing CRX100 suspension for infusion, Fludarabine and Cyclophosphamide in people with Solid Tumor, Adult and Triple Negative Breast Cancer, run by BioEclipse Therapeutics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer
- What is being tested?
- CRX100 suspension for infusion, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Jan 2021to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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 four weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- Subjects who received any chemotherapy or immunotherapies (non-cell-based therapies) or oncolytic virus therapy, radiotherapy, radiosurgery or investigational agents within three weeks of enrollment.
- Subjects who still are experiencing Grade 2 or higher AEs from prior therapies such as surgery, radiation therapy and systemic anti-cancer therapies unless approved by sponsor.
- Subjects who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date.
- Subjects experiencing any active infections (bacterial, viral, or fungal) for which systemic antimicrobials are required. Subjects who need prophylactic anti-viral agents that can inhibit the replication of VACV will be excluded from participating.
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- Subjects must not have history of active or symptomatic autoimmune disease or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, other symptomatic autoimmune disease, documented history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e., with use of disease modifying agents, steroids or immunosuppressive agents) Exceptions are permitted for vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition requiring only hormone replacement, psoriasis not requiring systemic treatment, conditions not expected to recur in the absence of an external trigger or other conditions approved by the medical monitor.
- 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, intramuscular injection, or topical steroids and adrenal replacement doses (≤10 mg daily prednisone equivalents) are permitted. Stable doses of steroids are permitted for subjects with pre-treated brain metastases. 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.
- Pregnant or nursing an infant (subject or household contacts).
- 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 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 two 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 must discuss the subject with the Medical Monitor.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pamela Contag, PhD Chief Executive Officer contact
United States3 sites, 3 recruiting
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Natalia Ortuno, 858-246-2073, nortuno@health.ucsd.edu
Sandip Patel, MD
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Patricia Shannon, 480-323-1364, clinicaltrials@honorhealth.com
Justin Moser, MD
- Recruiting
Stanford University
Stanford, California, 94305
Mary Herrera, 650-723-0622, ccto-office@stanford.edu
Oliver Dorigo, MD
About this study
Official title: A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies
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
- Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Osteosarcoma, Epithelial Ovarian Cancer
- Being tested
- CRX100 suspension for infusion, Fludarabine, Cyclophosphamide
- Medical subject headings
- Triple Negative Breast Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular, Osteosarcoma, Carcinoma, Ovarian Epithelial, Stomach Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRX100 suspension for infusionBiological
A fixed dose of CIK cells combined with the specified dose of CDSR.
FludarabineCombination product
25mg/m IV (five doses given from Day -7 until Day -3)
CyclophosphamideCombination product
60mg/kg intravenous (IV) (two doses given on Day -7 and -6)
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose-Escalation Cohorts | Experimental | 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. Receives: Biological: CRX100 suspension for infusion; Combination Product: Fludarabine; Combination Product: Cyclophosphamide |
| Combination Therapy Cohorts | Experimental | 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. Receives: Biological: CRX100 suspension for infusion; Combination Product: Fludarabine; Combination Product: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities
The Primary Outcome Measure will be based on the frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities during and after the administration of investigational drug in monotherapy and investigational drug with combination therapy.
Measured: 28 days following dose administration for each dosed subject.
Determine the maximum tolerated dose (MTD), maximum feasible dose (MFD) or optimal biological dose (OBD) and determine recommended Phase 1b/Phase 2a dose level.
Review of safety review committee following subject treatment to review any AEs, SAEs, or DLTs
Measured: 28 days following dose administration for each dosed subject.
Secondary outcomes (3)
Biodistribution of CRX100 based on subject's viral load as assessed through a viral shedding assay.
To characterize the biodistribution of CRX100 based on each subject's viral load as assessed through a viral shedding assay, following a single dose of investigational product.
Measured: 28 days following dose administration for each dosed subject.
Immune response to investigational drug based on subject's levels of neutralizing antibodies.
Levels of neutralizing vvDD antibodies will be summarized by dose level and time point following a single dose of investigational product.
Measured: 28 days following dose administration for each dosed subject.
Early anti-tumor activity of investigational drug based on iRECIST criteria
Summarized based on best response observed using RECIST classification of response. Overall response and frequencies of each level of response.
Measured: 6 months after dose administration for each dosed subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start8 Jan 2021
- Primary completionAug 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioEclipse Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Dorigo, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282044
- Sponsor's protocol ID
- CRX100-001
- Status last verified
- Feb 2024
- First submitted
- 18 Feb 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT04282044
- Acronym / sponsor ID
- CRX100-001
- Conditions
- Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer, Hepatocellular Carcinoma, Osteosarcoma, Epithelial Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BioEclipse TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose-Escalation Cohorts | Experimental | Biological: CRX100 suspension for infusion, Combination Product: Fludarabine, Combination Product: CyclophosphamidePrior 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. |
| Combination Therapy Cohorts | Experimental | Biological: CRX100 suspension for infusion, Combination Product: Fludarabine, Combination Product: CyclophosphamideSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (13 listed)
- 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 four weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
- Subjects who received any chemotherapy or immunotherapies (non-cell-based therapies) or oncolytic virus therapy, radiotherapy, radiosurgery or investigational agents within three weeks of enrollment.
- Subjects who still are experiencing Grade 2 or higher AEs from prior therapies such as surgery, radiation therapy and systemic anti-cancer therapies unless approved by sponsor.
- Subjects who received any type of cell-based therapies within the last 12 weeks from the planned apheresis date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRX100 suspension for infusionA fixed dose of CIK cells combined with the specified dose of CDSR. | Biological | Combination Therapy Cohorts, Monotherapy Dose-Escalation Cohorts |
| Fludarabine25mg/m IV (five doses given from Day -7 until Day -3) | Combination product | Combination Therapy Cohorts, Monotherapy Dose-Escalation Cohorts |
| Cyclophosphamide60mg/kg intravenous (IV) (two doses given on Day -7 and -6) | Combination product | Combination Therapy Cohorts, Monotherapy Dose-Escalation Cohorts |
Primary outcome
Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities
Time frame: 28 days following dose administration for each dosed subject.
The Primary Outcome Measure will be based on the frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities during and after the administration of investigational drug in monotherapy and investigational drug with combination therapy.
Determine the maximum tolerated dose (MTD), maximum feasible dose (MFD) or optimal biological dose (OBD) and determine recommended Phase 1b/Phase 2a dose level.
Time frame: 28 days following dose administration for each dosed subject.
Review of safety review committee following subject treatment to review any AEs, SAEs, or DLTs
3 secondary outcomes
Biodistribution of CRX100 based on subject's viral load as assessed through a viral shedding assay.
Time frame: 28 days following dose administration for each dosed subject.
Immune response to investigational drug based on subject's levels of neutralizing antibodies.
Time frame: 28 days following dose administration for each dosed subject.
Early anti-tumor activity of investigational drug based on iRECIST criteria
Time frame: 6 months after dose administration for each dosed subject.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Contag, PhD Chief Executive Officer contact
Oliver Dorigo, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRX100 suspension for infusion, Fludarabine and Cyclophosphamide in people with Solid Tumor, Adult and Triple Negative Breast Cancer, run by BioEclipse Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Lindal (206-229-5827, clinical@bioeclipse.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent Adverse Events and Dose Limiting Toxicities (time frame: 28 days following dose administration for each dosed subject.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.