Open
Actively Recruiting
PRO1184 for Advanced Solid Tumors
About
Brief Summary
This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative and triple-negative), mesothelioma
- previously received therapies known to confer clinical benefit
- willing to provide a tumor sample (archive tissue or fresh biopsy)
- ECOG performance status 0 or 1
- measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline
- adequate hematologic, hepatic, renal and cardiac function Part C: High grade ovarian cancer:
- Patients must have platinum-resistant/refractory ovarian cancer
- Patients must have received prior bevacizumab
- Patients with known or suspected deleterious germline or somatic BRCA mutations must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor
- Patients must have previously received mirvetuximab soravtansine, if indicated based on an FDA approved test for FRα expression (i.e., FRα PS2+ membrane expression in at least 75% of tumor cells), unless the patient has a documented medical exception
- Prior induction plus maintenance is considered 1 line of therapy, even if parts of the treatment regimen (induction or maintenance) are interrupted and/or resumed at a later date, in the absence of disease progression while on active treatment
- A switch/change in regimen due solely to toxicity or patient preference (and not disease progression) is not considered a separate line of therapy Part D: Cohort D1 (PRO1184+carboplatin):
- Patients must have platinum-sensitive ovarian cancer
- Patients must have received 1 to 3 prior lines of therapy Cohort D2 (PRO1184+bevacizumab): -Patients must have platinum-resistant/refractory ovarian cancer Cohort D3 (PRO1184+pembrolizumab):
- Endometrial cancer (any subtype excluding sarcoma)
- Patients must have received prior platinum-based chemotherapy for recurrent or advanced disease
Exclusion Criteria:
- other malignancy within 3 years
- active CNS metastases (treated, stable CNS metastases are allowed)
- uncontrolled Grade 3 or greater infection within 2 weeks
- positive for HBV, HCV or HIV
- use of a strong CYP3A inhibitor within 14 days (dose escalation only)
- prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate
* additional protocol defined inclusion/exclusion criteria may apply
Join this Trial
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Study Stats
Protocol No.
23-000166
Category
Other Cancer
Ovarian Cancer
Principal Investigator
Contact
Location
- UCLA Westwood