Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors
Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors
NCT #
NCT05579366
Condition(s)
Breast, Endometrial, Mesothelioma, Non-Small Cell Lung, Ovarian, triple negative Breast
Molecular Target(s)
FRĪ±
Drug Classification(s)
Antibody Drug Conjugate
Agents(s)
PRO1184
Phase(s)
I/II
Mechanism of Action
PRO1184 is an antibody drug conjugate that is directed to folate molecules to bind to cells with folate receptor in order to deliver the attached cytotoxic payload molecules
Purpose
- How much of the study agent can be given with an acceptable level of side effects
- The effects of the study agent (good and bad)
- How much of the study agent is absorbed into the blood and how fast it is removed
- If research tests can be used in the future to predict who will benefit from PRO1184
- How the study agent is acting on your body
- 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
- For Part B, evidence of folate receptor alpha expression in tumor cells
- 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 P450 CYP3A inhibitor within 14 days (dose escalation only)
- additional protocol defined inclusion/exclusion criteria may apply
No restrictions
Location
MCD
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