SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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:
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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.
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Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
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Eastern Cooperative Oncology Group (ECOG) 0-1.
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Adequate hematologic, hepatic, and renal function.
Exclusion criteria
- Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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