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.
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.
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.
Sequential
Spedox-6
DrugGiven Intravenously (IV)
Pegfilgrastim
DrugGiven Subcutaneous Injection or IV
Filgrastim
DrugGiven Subcutaneous Injection or IV
8
Treatment groupsSee each treatment group below.
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
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).
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.
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
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).
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
Overall Survival
Survival rate of subjects who received at least one dose of Spedox-6.
Progression Free Survival
Survival rate of subjects who received at least one dose of Spedox-6 without Progression of their disease.
Correlation between Tumor FcRn Expression (IHC Score) and Objective Response (per RECIST v1.1)
E valuate the correlation between tumor neonatal Fc receptor (FcRn) expression, as measured by immunohistochemistry (IHC) H-score, and objective tumor response, defined per RECIST v1.1 criteria (Complete Response or Partial Response).
Correlation between Tumor FcRn Expression (IHC Score) and Disease Control (CR + PR + SD per RECIST v1.1)
To evaluate the correlation between tumor neonatal Fc receptor (FcRn) expression, as assessed by immunohistochemistry (IHC) H-score, and disease control, defined as the proportion of patients achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RECIST v1.1.
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University of California, Irvine
Lead sponsor
Sunstate Biosciences LLC
Collaborator
