A Study of PY314 in Subjects With Advanced Solid Tumors
NCT04691375 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2024-03-22
Summary
This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).
Conditions
- Advanced Solid Tumor
- Gynecologic Cancer
- Breast Cancer
- Colorectal Cancer
- Lung Adenocarcinoma
- Renal Cell Carcinoma
- Triple Negative Breast Cancer
- Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer
- Ovarian Cancer
Interventions
- DRUG
-
PY314
Dose of PY314 as a single agent given in a standard 3+3 design.
- DRUG
-
Combination Therapy: PY314 + Pembrolizumab
Dose of PY314 alone and given in combination with pembrolizumab
Sponsors & Collaborators
-
Ikena Oncology
lead INDUSTRY
Principal Investigators
-
Len Reyno, MD · Ikena Oncology
-
Marc Chamberlain, MD · Ikena Oncology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-29
- Primary Completion
- 2023-08-31
- Completion
- 2023-09-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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