Soft-tissue SarcomaPhase 1/2NCT07064018
Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
A Phase 1/2 study testing Spedox-6, Pegfilgrastim and Filgrastim in people with Soft-tissue Sarcoma and Triple Negative Breast Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft-tissue Sarcoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Spedox-6, Pegfilgrastim and Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to 31 Dec 2031
- Phase
- Phase 1/2
- 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 ≥ 18 years at the first screening examination/visit.
- Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous therapies.
- Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level.
- Disease that is considered measurable by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy of at least 12 weeks.
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- Human Immunodeficiency Virus (HIV)-positive trial participants should be on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies/mL prior to enrollment.
- Left ventricular ejection fraction > 50%.
- Adequate organ function: (Hb ≥10 g/dL, ANC ≥1,000/µL3, and platelets
- ≥100,000/µL3), serum bilirubin ≤.5x the institutional upper limit of normal (ULN) (unless known Gilbert's disease), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3x ULN, and creatinine clearance >50 mL/min as assessed by Cockcroft-Gault equation.
- For patients with known Gilbert's disease, serum unconjugated bilirubin must be < 4 mg/dL.
- Patient must have washed out of prior chemotherapy (at least 3 weeks from last end of therapy), radiotherapy (at least 4 weeks from last end of therapy), immunotherapy (at least 4 weeks from last end of therapy), other targeted therapies (at least 4 weeks from last end of therapy), or surgery (at least 4 weeks).
- Recovery from toxicities of prior therapy. Toxicities should have recovered to CTCAE grade ≤ 1 or baseline with exception of alopecia.
- Females of reproductive potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment. Additionally, female subjects of reproductive potential should agree to use effective acceptable forms of contraception: surgical sterilization (tubal ligation); total abstinence from sexual intercourse with the opposite sex; established hormonal birth control (e.g., oral, transdermal, injection, or implant) plus a barrier method or a double barrier method (intrauterine device, spermicide, or a diaphragm plus condom) for at least 1 month prior to Cycle 1 Day 1 and agreement to use such a method during study participation and for an additional 6 months after the last dose of SPEDOX-6.
- For males of reproductive potential: vasectomy or highly effective contraception (e.g., condoms, abstinence) during the study and for an additional 6 months after the last dose of SPEDOX-6.
Who cannot join
- Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted treatment for their mutations and progressed, or those treatments are contraindicated, they will be considered potentially eligible.
- Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
- Untreated metastases to the Central Nervous System (CNS).
- Have received any prior doxorubicin or anthracycline equivalent.
- Previous radiation to the mediastinal or pericardial area.
- A known allergy to albumin.
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- HIV infection with CD4+ count < 350 cells/µL or Acquired Immunodeficiency (AIDS)-defining opportunistic infection in previous 12 months.
- Pregnant (positive serum or urine pregnancy test) or lactating.
- Previous treatment with an investigational agent or the non-approved use of a drug or device withing 4 weeks of study entry.
- Uncontrolled diabetes mellitus.
- Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P-glycoprotein (P-gp).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical Center contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
Warren Chow, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
This is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal adenocarcinoma. These are subjects who have not previously been treated with anthracyclines.
- Conditions
- Soft-tissue Sarcoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, KRAS Mutation-Related Tumors
- Being tested
- Spedox-6, Pegfilgrastim, Filgrastim
- Medical subject headings
- Sarcoma, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spedox-6Drug
Given Intravenously (IV)
PegfilgrastimDrug
Given Subcutaneous Injection or IV
FilgrastimDrug
Given Subcutaneous Injection or IV
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose Level 1 - Spedox-6 | Experimental | Spedox-6, 20 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Receives: Drug: Spedox-6 |
| Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 40 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
| Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 80 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
| Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 120 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
| Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 160 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
| Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 200 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
| Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 250 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
| Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Spedox-6, 310 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.
Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. Receives: Drug: Spedox-6; Drug: Pegfilgrastim; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) by RECIST v1.1
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
Measured: 2 Years
Disease Control Rate (DCR) by RECIST v1.1
Disease Control Rate (DCR) defined as Sum of Stable Disease (SD) + Partial Response (PR) + Complete Response (CR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD is defined as an increase of at least 20% in the sum of the longest diameters of the target lesions, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD) is defined as a tumor that has neither shrunk sufficiently to qualify as a partial response (PR) nor increased sufficiently to qualify as progressive disease (PD).
Measured: 2 Years
Complete Response Rate by RECIST v1.1
Complete Response Rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is defined as the disappearance of all target lesions.
Measured: 2 years
Partial Response Rate by RECIST v1.1
Partial Response rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions
Measured: 2 years
Secondary outcomes (9)
Stable Disease Rate by RECIST v1.1
Stable Disease Rate by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD is defined as an increase of at least 20% in the sum of the longest diameters of the target lesions, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD) is defined as a tumor that has neither shrunk sufficiently to qualify as a partial response (PR) nor increased sufficiently to qualify as progressive disease (PD).
Measured: 2 years
Percentage of Responders by RECIST v1.1
Sum of Complete Response (CR) + Partial Response (PR) to determine Percentage of Responders by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Complete Response (CR) is defined as the disappearance of all target lesions. Percentage of Responders (POR) = CR + PR
Measured: 2 years
Overall Survival
Survival rate of subjects who received at least one dose of Spedox-6.
Measured: 2 years
Progression Free Survival
Survival rate of subjects who received at least one dose of Spedox-6 without Progression of their disease.
Measured: 2 years
Number of Patients with Grade 3 non-hematological toxicities by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Number of Patients who received at least one dose of Spedox-6 with Grade 3 non-hematological toxicities (excluding alopecia) by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0 with the following exceptions: Grade 3 nausea/vomiting or diarrhea <72 hours with adequate antiemetic and other supportive care; Grade 3 fatigue <1 week; Grade 3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated and resolves spontaneously or responds to conventional medical interventions.
Measured: 2 years
Number of patients with Grade 4 non-hematologic (non-laboratory) by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Number of patients who received at least one dose of Spedox-6 with Grade 4 non-hematologic (non-laboratory) toxicity of any duration per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Number of patients with Grade 3 or Grade 4 febrile neutropenia by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Number of patients who received at least one dose of Spedox-6 with Grade 3 or Grade 4 febrile neutropenia of any duration per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Number of patients with Grade 3 Thrombocytopenia in Combination with Grade 3 or greater blood and lymphatic system disorder by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Number of patients who received at least one dose of Spedox-6 with Grade 3 Thrombocytopenia in Combination with Grade 3 or greater blood and lymphatic system disorder per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Number of patients with Grade 3 AST or ALT increase that is associated with a Grade 2 or greater Rise in Bilirubin by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Number of patients who received at least one dose of Spedox-6 with Grade 3 AST or ALT increase that is associated with a Grade 2 or greater Rise in Bilirubin per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start30 Apr 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft-tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstate Biosciences LLC
- Responsible party
- Principal investigator, Warren Chow, University of California, Irvine
- Investigators
- Warren Chow, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064018
- Sponsor's protocol ID
- 6228
- Other IDs
- UCI 24-08
- Status last verified
- Jul 2026
- First submitted
- 27 May 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies
- ClinicalTrials.gov ID
- NCT07064018
- Acronym / sponsor ID
- 6228
- Conditions
- Soft-tissue Sarcoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Cervical Cancer, Ovarian Cancer, KRAS Mutation-Related Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Sunstate Biosciences LLC
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Jul 2025 (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 is a Phase 1b/IIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal adenocarcinoma. These are subjects who have not previously been treated with anthracyclines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose Level 1 - Spedox-6 | Experimental | Drug: Spedox-6Spedox-6, 20 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. |
| Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 40 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
| Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 80 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
| Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 120 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
| Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 160 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
| Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 200 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
| Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 250 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
| Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim | Experimental | Drug: Spedox-6, Drug: Pegfilgrastim, Drug: FilgrastimSpedox-6, 310 mg/m2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles. Filgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects ≥ 18 years at the first screening examination/visit.
- Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous therapies.
- Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level.
- Disease that is considered measurable by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Key exclusion criteria (11 listed)
- Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted treatment for their mutations and progressed, or those treatments are contraindicated, they will be considered potentially eligible.
- Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.
- Untreated metastases to the Central Nervous System (CNS).
- Have received any prior doxorubicin or anthracycline equivalent.
- Previous radiation to the mediastinal or pericardial area.
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 |
|---|---|---|
| Spedox-6Given Intravenously (IV) | Drug | Phase 1b Dose Level 1 - Spedox-6, Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim |
| PegfilgrastimGiven Subcutaneous Injection or IV | Drug | Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim |
| FilgrastimGiven Subcutaneous Injection or IV | Drug | Phase 1b Dose Level 2 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 3 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 4 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 5 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 6 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 7 - Spedox-6 + Filgrastim/Pegfilgrastim, Phase 1b Dose Level 8 - Spedox-6 + Filgrastim/Pegfilgrastim |
Primary outcome
Overall Response Rate (ORR) by RECIST v1.1
Time frame: 2 Years
Sum of Complete Response (CR) and Partial Response (PR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR
Disease Control Rate (DCR) by RECIST v1.1
Time frame: 2 Years
Disease Control Rate (DCR) defined as Sum of Stable Disease (SD) + Partial Response (PR) + Complete Response (CR) by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD is defined as an increase of at least 20% in the sum of the longest diameters of the target lesions, with an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD) is defined as a tumor that has neither shrunk sufficiently to qualify as a partial response (PR) nor increased sufficiently to qualify as progressive disease (PD).
Complete Response Rate by RECIST v1.1
Time frame: 2 years
Complete Response Rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is defined as the disappearance of all target lesions.
Partial Response Rate by RECIST v1.1
Time frame: 2 years
Partial Response rate assessed by RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions
9 secondary outcomes
Stable Disease Rate by RECIST v1.1
Time frame: 2 years
Percentage of Responders by RECIST v1.1
Time frame: 2 years
Overall Survival
Time frame: 2 years
Progression Free Survival
Time frame: 2 years
Number of Patients with Grade 3 non-hematological toxicities by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2 years
Number of patients with Grade 4 non-hematologic (non-laboratory) by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Time frame: 2 years
Number of patients with Grade 3 or Grade 4 febrile neutropenia by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Time frame: 2 years
Number of patients with Grade 3 Thrombocytopenia in Combination with Grade 3 or greater blood and lymphatic system disorder by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Time frame: 2 years
Number of patients with Grade 3 AST or ALT increase that is associated with a Grade 2 or greater Rise in Bilirubin by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 version 5.0
Time frame: 2 years
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 17 Jul 2026.
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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.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical Center contact
Warren Chow, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spedox-6, Pegfilgrastim and Filgrastim in people with Soft-tissue Sarcoma and Triple Negative Breast Cancer, run by University of California, Irvine at 1 site 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 15 inclusion and 11 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) by RECIST v1.1 (time frame: 2 Years). The study lists 4 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 17 Jul 2026.