Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector
(Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination
with anti-programmed death ligand-1 (PD-L1) antibody, durvalumab, in adult subjects with
peritoneal disease who have failed prior standard chemotherapy and have histologically
confirmed epithelial ovarian cancer or metastatic colorectal cancer.
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Institutional
Disease
Gynecologic Cancer
Enrollment Eligibility
Inclusion Criteria:
1. Subjects with peritoneal disease who have failed prior standard chemotherapy and have
histologic confirmation of epithelial ovarian cancer or metastatic colorectal cancer
(CRC) including cancer originating from the appendix.
2. Subject is willing to undergo a core needle biopsy during screening and Cycle 2, Study
Week 5. Archival tumor samples are requested but are not required for eligibility.
3. Previously treated for advanced cancer with no additional therapy options available
known to prolong survival.
4. Laboratory parameters for vital functions should be in the normal range or not
clinically significant.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Exclusion Criteria:
1. Treatment with an investigational agent within 4 weeks of starting study treatment or
prior treatment with a checkpoint inhibitor (cytotoxic T-lymphocyte-associated protein
4 [CTLA-4], programmed cell death protein 1 [PD-1] or programmed death ligand 1
[PD-L1] antibodies).
2. Subject has known active central nervous system metastasis, glioma and nervous system
malignancies including carcinomatous meningitis. Subjects with asymptomatic brain
metastases or spinal cord compression who have been treated, are considered stable,
and who have not received corticosteroids or anticonvulsants for at least 28 days
prior to screening may be included. Subject has other active malignancy.
3. Known immunodeficiency or known to have evidence of acute or chronic human
immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C or other uncontrolled
inter-current illnesses.
4. Ongoing bowel perforation or presence of bowel fistula or abscess or history of small
or large bowel obstruction within 3 months of registration, including subjects with
palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or
colostomy are allowed if they have been symptom-free for more than 3 months.
5. Subjects with clinically significant cardiovascular disease, history of organ
transplant or allogeneic bone marrow transplant, active known or history of autoimmune
disease that might recur or major surgery within 28 days prior to the first dose or
still recovering from prior surgery.