SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers

  • Interventional
  • Not Recruiting
  • NCT03138408
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
Female

Age Group
18 Years and up

Accepting 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.

At a Glance

National Government IDNCT03138408

IRB#IRB17-1396

Lead SponsorAbbVie

Lead PhysicianGini Fleming

Collaborator(s)N/A

EligibilityFemale
18 Years and up
Not Recruiting