Adenoid Cystic Carcinoma
Conditions
Brief summary
Phase II open label study designed to evaluate the efficacy and safety of P-Sam in patients with aggressive, solid, NOTCH mutant or p63 low (B7-H4 high) R/M ACC-I patients.
Detailed description
Primary Objective: To assess the objective response rate and safety of P-Sam in patients with R/M ACC-I. Secondary Objectives: To estimate the disease control rate (DCR) To estimate the median duration of response (DOR) To estimate the median progression-free survival (PFS) To estimate the PFS rate at 3 and 6 months To estimate the median overall survival (OS) To assess patient's quality of life (QoL) during P-Sam therapy Tertiary/Exploratory Objectives: To explore tissue and blood-based biomarkers that may predict response to therapy.
Interventions
DRUGP-Sam
Given by IV
Sponsors
M.D. Anderson Cancer Center
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥18 years with histology-proven advanced, or R/M ACC. 2. Evidence of locally advanced disease not amenable to curative intent surgery or radiotherapy, or recurrent/metastatic disease 3. ACC-I subtype defined by at least one of the following: 1. Presence of an activating NOTCH mutation per in-house or any CLIA-certified or commercially available next-generation sequencing assay 2. Solid histology and clinical course characterized by \< 3 years from diagnosis to initial recurrence or progression or de novo metastatic disease with extra-pulmonary metastasis 3. Negative TP63 tumor expression by IHC (\<10% of tumor cells) 4. Measurable disease per RECIST 1.1 5. Performance status ECOG of 0 or 1 6. Patient has provided informed consent. 7. Adequate bone marrow, hepatic, and renal function with the most recent laboratory assessments 8. Contraceptive use by the participant or the participant's partner should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. (a) Male participants: (i) Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use a male condom (plus spermicide, if available) from enrollment throughout the study and for 8 months following the last dose of study drug. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period, as described in Table 3. In addition, male participants must refrain from sperm donation while on study and for 8 months (5 half-lives plus 6 months) following the last dose of study drug. (b) Female participants: (i) Females of childbearing potential must have a negative urine or serum pregnancy test prior to receiving the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. (ii) Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly, from enrollment throughout the study and for 8 months following the last dose of study drug. It is strongly recommended for the male partner of a female participant to also use male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. 9\. Patients can be treatment-naïve or have received up to 3 lines of prior systemic therapy in the setting ofR/M disease, however, a maximum of two prior lines of chemotherapy or antibody-drug conjugate (ADC) are allowed. Exceptions include prior B7-H4-targeting ADC or any prior agent with a topoisomerase inhibitor 1 mode of action; those represent
Exclusion criteria
(
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTRenata Ferrarotto, MD
PRINCIPAL_INVESTIGATORRenata Ferrarotto, MD
M.D. Anderson Cancer Center
Outcome results
None listed