Cancer
Conditions
Keywords
Ovarian cancer, Endometrial cancer, SC-004, Maximum tolerated dose (MTD), ABBV-181
Brief summary
This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.
Interventions
DRUGSC-004
Intravenous
DRUGABBV-181
Intravenous
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator: * Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy. * Note, the line of therapy limit does not apply to the biopsy substudy cohorts. * Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen. * Eastern Cooperative Oncology Group (ECOG) 0-1. * Adequate hematologic, hepatic, and renal function.
Exclusion criteria
* Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLT) | Minimum first cycle of dosing (21-day cycles) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Approximately 2 years | OS is defined as the time from the subject's first dose date to death due to any cause. |
| Objective Response Rate (ORR) | Approximately 2 years | ORR is defined as the proportion of subjects with complete response or partial response (CR+PR). |
| Terminal half life (T1/2) | Approximately 1 year | Terminal half life (T1/2). |
| Maximum observed serum concentration (Cmax) | Approximately 1 year | Maximum observed serum concentration. |
| Time to Cmax (Tmax) | Approximately 1 year | Time to Cmax. |
| Observed plasma concentrations at trough (Ctrough) | Approximately 1 year | Observed plasma concentrations at trough. |
| Progression Free Survival (PFS) | Approximately 2 years | PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression or death due to any cause, whichever occurs first. Under the situation that neither event occurs, the PFS time will be censored at the date of last tumor assessment. Subjects lacking an evaluation of tumor response after their first dose of study treatment will have their event time censored at Day 1. |
| Duration of Response (DOR) | Approximately 2 years | DOR is defined as the time from the subject's initial objective response (CR or PR) to study drug therapy to disease progression or death due to any cause, whichever occurs first. If the dates of disease progression or death are not available, the DOR will be censored at the date of last valid tumor assessment. |
| Area under the plasma concentration-time curve within a dosing interval (AUC) | Approximately 1 year | Area under the plasma concentration-time curve within a dosing interval. |
| QTcF Change from Baseline | Up to 9 weeks based on 3 cycles of dosing (21-day cycles) | QT interval measurement corrected by Fridericia's formula (QTcF). |
| Duration of Clinical Benefit (DOCB) | Approximately 2 years | DOCB is defined as the time from a subject's objective response (CR or PR) or stable disease (SD) to study drug therapy to disease progression or death due to any cause whichever occurs first. |
| Clinical Benefit Rate (CBR) | Approximately 2 years | CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD). |
Countries
United States
Outcome results
None listed