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A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

NCT04682431•Ikena Oncology

View on ClinicalTrials.gov

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).

Detailed Description

Part A: Dose escalation of PY159 alone and in combination with pembrolizumab in a standard 3+3 design Part B: Dose expansion of one or more dose levels of PY159 administered alone and in combination with pembrolizumab for predefined tumor histology

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults ≥18 years of age at the time of study consent
•Subjects with any of the following eligible solid tumor diagnoses as confirmed by cytology or histology. Escalation Cohorts (Part A): Subjects with advanced solid tumors from pre-specified tumor types:
•* head and neck \[squamous cell carcinoma, salivary gland, thyroid\],
•* gynecologic \[including ovarian, fallopian, primary peritoneal, endometrial, cervical, uterine, vaginal, vulvar\],
•* pancreatic \[adenocarcinoma\],
•* lung \[adenocarcinoma and squamous cell carcinoma\] who are recurrent or refractory to platinum-based chemotherapy in addition to prior treatment with CPI Programmed Cell Death-1 (PD-1)/Programmed Cell Death-Ligand 1 (PD-L1) or who give informed consent to forego such therapy,
•* gastric and esophagogastric junction adenocarcinomas \[MSI low and CPI refractory MSI high\],
•Subjects must have documented radiographic disease progression that include prior treatment with a CPI (alone or in combination), if approved for that indication.
•There is no limit to the number of prior treatments
•Measurable disease by RECIST 1.1.
+2 more criteria

Exclusion Criteria

•Subject is a candidate for approved molecularly targeted therapy (e.g., drugs targeting EGFR,VEGF, ALK, ROS-1, NTRK, MET, RET, and BRAF V600E, HER2). Applies to enrolled subjects on both Part A and Part B of the study.
•History of autoimmune disorder requiring ongoing or intermittent disease-modifying therapy excluding thyroid disease well controlled on replacement therapy.
•Untreated and/or uncontrolled brain metastases Stable treated or asymptomatic brain metastases (for at least 1 month prior to enrollment may be enrolled. Subjects with stable treated or asymptomatic brain metastases receiving glucocorticoids must be on a stable dose \[≤ 2 mg/day of dexamethasone or an equivalent glucocorticoid\] for a minimum of 1month prior to enrollment.)
•Uncontrolled intercurrent illness including, but not limited to, active SARS-CoV-2 infection, active or chronic bleeding event within 28 days prior to first dose of study drug or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician.
•Decompensated liver disease as evidenced by hepatic encephalopathy or coagulopathy.
•Active angina or Class III or IV Congestive Heart Failure (CHF) (NYHA CHF Functional Classification System) or clinically significant cardiac disease within 12 months of first dose. of study drug, including MI, unstable angina, Grade 2 or greater peripheral vascular disease, uncontrolled HTN, or arrhythmias not controlled by medication.
•Any anti-cancer therapy, including small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy (with the exception of bone-modifying agents as supportive care), radiotherapy or any other agents to treat cancer within 14-21 days (dependent upon the agent and drug half-life) of first dose of study drug. Subjects with a prior history of prostate cancer on LHRH agonist are eligible provided they have no evidence of metastatic disease.

Locations (17)

USC Norris Cancer Center

Los Angeles, California, United States

UCSF Mount Zion Cancer Center

San Francisco, California, United States

UCLA Parkside Cancer Center

Santa Monica, California, United States

University of Colorado

Aurora, Colorado, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Florida Cancer Specialists - Sarasota - SCRI

Sarasota, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Key Dates

Start Date

November 10, 2020

Primary Completion Date

August 25, 2023

Completion Date

August 31, 2023

Last Updated

March 22, 2024

Enrollment

127

ACTUAL participants

Conditions

Advanced Solid TumorGynecologic CancerBreast CancerColorectal CancerGastric AdenocarcinomaLung AdenocarcinomaPancreatic CancerHead and Neck Cancer

Interventions

PY159 Single agent dose level 1

DRUG

PY159 Single agent dose level 2

DRUG

PY159 Single agent dose level 3

DRUG

PY159 Single agent dose level 4

DRUG

PY159 Single agent dose level 5

DRUG

PY159 Single agent dose level 6

DRUG

PY159 Single agent dose level 7

DRUG

PY159/Pembrolizumab Combination dose level 1

DRUG

PY159/Pembrolizumab Combination dose level 2

DRUG

PY159/Pembrolizumab Combination dose level 3

DRUG

PY159/Pembrolizumab Combination dose level 4

DRUG

PY159 Single agent dose expansion cohort

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 1

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 2

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 3

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 4

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 5

DRUG

PY159/Pembrolizumab Combination dose expansion cohort 6

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of PYX-201 in Advanced Solid Tumors