SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/31/2019 |
Start Date: | June 14, 2017 |
End Date: | June 15, 2021 |
An Open Label, Phase 1 Study of SC-004 as Monotherapy and in Combination With ABBV-181 in Subjects With Epithelial Ovarian, Including Fallopian Tube and Primary Peritoneal and Endometrial Cancers
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.
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.
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.
We found this trial at
12
sites
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