NCT04682431View on ClinicalTrials.gov

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

PHASE1TerminatedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

November 10, 2020

Primary Completion Date

August 25, 2023

Study Completion Date

August 31, 2023

Conditions
Advanced Solid TumorGynecologic CancerBreast CancerColorectal CancerGastric AdenocarcinomaLung AdenocarcinomaPancreatic CancerHead 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

Trial Locations (17)

19107

Thomas Jefferson University, Philadelphia

34232

Florida Cancer Specialists - Sarasota - SCRI, Sarasota

44106

Case Western Reserve University, Cleveland

48201

Karmanos Cancer Institute, Detroit

73019

The University of Oklahoma, Norman

75230

Mary Crowley Cancer Center, Dallas

77030

The University of Texas MD Anderson Cancer Center, Houston

78229

Start South Texas Accelerated Research Therapeutic, San Antonio

80045

University of Colorado, Aurora

90089

USC Norris Cancer Center, Los Angeles

90404

UCLA Parkside Cancer Center, Santa Monica

94115

UCSF Mount Zion Cancer Center, San Francisco

97239

Oregon Health and Science University, Portland

06511

Smilow Cancer Hospital at Yale New Haven, New Haven

46202-5116

Indiana University, Indianapolis

02114

Massachusetts General Hospital, Boston

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors

Lead Sponsor

Ikena Oncology
All Listed Sponsors
lead

Ikena Oncology

INDUSTRY

NCT04682431 - A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter