A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Summary

This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, if approved for that indication).

Conditions

• Advanced Solid Tumor
• Gynecologic Cancer
• Breast Cancer
• Colorectal Cancer
• Gastric Adenocarcinoma
• Lung Adenocarcinoma
• Pancreatic Cancer
• Head and Neck Cancer

Interventions

DRUG

PY159 Single agent dose level 1

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159 Single agent dose level 2

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159 Single agent dose level 3

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159 Single agent dose level 4

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159 Single agent dose level 5

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159 Single agent dose level 6

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159 Single agent dose level 7

Dose of PY159 as a single agent given in a standard 3+3 design.

DRUG

PY159/Pembrolizumab Combination dose level 1

Dose of PY159 and given in combination with pembrolizumab

DRUG

PY159/Pembrolizumab Combination dose level 2

Dose of PY159 and given in combination with pembrolizumab

DRUG

PY159/Pembrolizumab Combination dose level 3

Dose of PY159 and given in combination with pembrolizumab

DRUG

PY159/Pembrolizumab Combination dose level 4

Dose of PY159 and given in combination with pembrolizumab

DRUG

PY159 Single agent dose expansion cohort

Dose of PY159 as a single agent given for predefined tumor histology

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 1

Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 2

Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 3

Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 4

Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 5

Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 6

Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

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

2020-11-10

Primary Completion

2023-08-25

Completion

2023-08-31

FDA Drug

Yes

Countries

• United States

Study Locations