AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT04682431

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

A Phase 1 study testing PY159 Single agent dose level 1, PY159 Single agent dose level 2 and PY159 Single agent dose level 3 in people with Advanced Solid Tumor and Gynecologic Cancer, run by Ikena Oncology at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PY159 Single agent dose level 1, PY159 Single agent dose level 2 and PY159 Single agent dose level 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
17 sitesUnited States
Study dates
10 Nov 2020to 31 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Mary Crowley Cancer Center

    Dallas, Texas, 75230

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202-5116

  • USC Norris Cancer Center

    Los Angeles, California, 90089

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06511

  • The University of Oklahoma

    Norman, Oklahoma, 73019

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Start South Texas Accelerated Research Therapeutic

    San Antonio, Texas, 78229

  • UCSF Mount Zion Cancer Center

    San Francisco, California, 94115

  • UCLA Parkside Cancer Center

    Santa Monica, California, 90404

  • Florida Cancer Specialists - Sarasota - SCRI

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: 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

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).

Read the 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

Being tested
PY159 Single agent dose level 1, PY159 Single agent dose level 2, PY159 Single agent dose level 3, PY159 Single agent dose level 4, PY159 Single agent dose level 5
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Adenocarcinoma of Lung, Pancreatic Neoplasms, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PY159 Single agent dose level 1Drug

    Also called PY159

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

  • PY159 Single agent dose level 2Drug

    Also called PY159

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

  • PY159 Single agent dose level 3Drug

    Also called PY159

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

  • PY159 Single agent dose level 4Drug

    Also called PY159

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

  • PY159 Single agent dose level 5Drug

    Also called PY159

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

  • PY159 Single agent dose level 6Drug

    Also called PY159

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

  • PY159 Single agent dose level 7Drug

    Also called PY159

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

  • PY159/Pembrolizumab Combination dose level 1Drug

    Also called PY159, Pembrolizumab

    Dose of PY159 and given in combination with pembrolizumab

  • PY159/Pembrolizumab Combination dose level 2Drug

    Also called PY159, Pembrolizumab

    Dose of PY159 and given in combination with pembrolizumab

  • PY159/Pembrolizumab Combination dose level 3Drug

    Also called PY159, Pembrolizumab

    Dose of PY159 and given in combination with pembrolizumab

  • PY159/Pembrolizumab Combination dose level 4Drug

    Also called PY159, Pembrolizumab

    Dose of PY159 and given in combination with pembrolizumab

  • PY159 Single agent dose expansion cohortDrug

    Also called PY159

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

  • PY159/Pembrolizumab Combination dose expansion cohort 1Drug

    Also called PY159, Pembrolizumab

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

  • PY159/Pembrolizumab Combination dose expansion cohort 2Drug

    Also called PY159, Pembrolizumab

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

  • PY159/Pembrolizumab Combination dose expansion cohort 3Drug

    Also called PY159, Pembrolizumab

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

  • PY159/Pembrolizumab Combination dose expansion cohort 4Drug

    Also called PY159, Pembrolizumab

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

  • PY159/Pembrolizumab Combination dose expansion cohort 5Drug

    Also called PY159, Pembrolizumab

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

  • PY159/Pembrolizumab Combination dose expansion cohort 6Drug

    Also called PY159, Pembrolizumab

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

Study groups in NCT04682431
Study groupRoleWhat they receive
Part A: PY159 Single agent dose level 1ExperimentalPY159 dose level 1 IV administration, Q3 weekly until consent withdrawal, intolerable toxicity or investigator decision.
Receives: Drug: PY159 Single agent dose level 1
Part A: PY159 Single agent dose level 2ExperimentalPY159 dose level 2
Receives: Drug: PY159 Single agent dose level 2
Part A: PY159 single agent dose level 3ExperimentalPY159 dose level 3
Receives: Drug: PY159 Single agent dose level 3
Part A: PY159 single agent dose level 4ExperimentalPY159 dose level 4
Receives: Drug: PY159 Single agent dose level 4
Part A: PY159 single agent dose level 5ExperimentalPY159 dose level 5
Receives: Drug: PY159 Single agent dose level 5
Part A: PY159 single agent dose level 6ExperimentalPY159 dose level 6
Receives: Drug: PY159 Single agent dose level 6
Part A: PY159 single agent dose level 7ExperimentalPY159 dose level 7
Receives: Drug: PY159 Single agent dose level 7
Part A: PY159/Pembrolizumab Combination dose level 1ExperimentalPY159 dose level 1 in combination with pembrolizumab
Receives: Drug: PY159/Pembrolizumab Combination dose level 1
Part A: PY159/Pembrolizumab Combination dose level 2ExperimentalPY159 dose level 2 in combination with pembrolizumab
Receives: Drug: PY159/Pembrolizumab Combination dose level 2
Part A: PY159/Pembrolizumab Combination dose level 3ExperimentalPY159 dose level 3 in combination with pembrolizumab
Receives: Drug: PY159/Pembrolizumab Combination dose level 3
Part A: PY159/Pembrolizumab Combination dose level 4ExperimentalPY159 dose level 4 in combination with pembrolizumab
Receives: Drug: PY159/Pembrolizumab Combination dose level 4
PY159 Part B: Single agent dose expansion cohort(s)ExperimentalPY159 Single agent dose expansion cohort(s)
Receives: Drug: PY159 Single agent dose expansion cohort
PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 1ExperimentalPY159 in combination with pembrolizumab dose expansion cohort 1 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Receives: Drug: PY159/Pembrolizumab Combination dose expansion cohort 1
PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 2ExperimentalPY159 in combination with pembrolizumab dose expansion cohort 2 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Receives: Drug: PY159/Pembrolizumab Combination dose expansion cohort 2
PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 3ExperimentalPY159 in combination with pembrolizumab dose expansion cohort 3 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Receives: Drug: PY159/Pembrolizumab Combination dose expansion cohort 3
PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 4ExperimentalPY159 in combination with pembrolizumab dose expansion cohort 4 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Receives: Drug: PY159/Pembrolizumab Combination dose expansion cohort 4
PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 5ExperimentalPY159 in combination with pembrolizumab dose expansion cohort 5 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Receives: Drug: PY159/Pembrolizumab Combination dose expansion cohort 5
PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 6ExperimentalPY159 in combination with pembrolizumab dose expansion cohort 6 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Receives: Drug: PY159/Pembrolizumab Combination dose expansion cohort 6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AE)

    Adverse Events will be summarized by MedDRA system organ class and preferred term. Separate tabulations will be produced for all treatment emergent AEs, treatment related AEs, Serious Adverse Events (SAEs), discontinuations due to AEs, and AEs of at least NCI CTCAE grade 3 severity.

    Measured: 36 months

  2. Dose Limiting Toxicity of PY159 (Part A only)

    Evaluation of dose-limiting toxicity (DLT).

    Measured: 21 days

Secondary outcomes (12)

  1. Measure PY159 concentration at the end of infusion (CEOI)

    Measure PY159 concentration at the end of infusion (CEOI) after the first dose.

    Measured: 36 months

  2. Measure PY159 maximum concentration (Cmax)

    Measure PY159 maximum concentration (Cmax) at various time points during Cycle 1. All subjects who received at least 1 dose of PY159 and have at least 1 measured concentration at a scheduled pharmacokinetics (PK) time point after start of dosing.

    Measured: 36 months

  3. Measure PY159 concentration at the trough level (Ctrough)

    Measure PY159 concentration at the trough level (Ctrough). All subjects who received at least 1 dose of PY159 and have at least 1 measured concentration at a scheduled PK time point after start of dosing.

    Measured: 36 months

  4. Measure PY159 Area under the curve (AUC)0-t

    Measure PY159 Area under the curve (AUC)0-t. All subjects who received at least 1 dose of PY159 and have at least 1 measured concentration at a scheduled PK time point after start of dosing for at least 1 PK analyte.

    Measured: 36 months

  5. Measure PY159 half-life (T1/2)

    Measure PY159 half-life (T1/2). All subjects who received at least 1 dose of PY159 and have at least 1 measured concentration at a scheduled PK time point after start of dosing for at least 1 PK analyte.

    Measured: 36 months

  6. Measure PY159 Clearance (CL)

    Measure PY159 Clearance (CL). All subjects who received at least 1 dose of PY159 and have at least 1 measured concentration at a scheduled PK time point after start of dosing for at least 1 PK analyte.

    Measured: 36 months

  7. Measure PY159 Volume at Steady State (Vss)

    Measure PY159 Volume at Steady State (Vss). All subjects who received at least 1 dose of PY159 and have at least 1 measured concentration at a scheduled PK time point after start of dosing for at least 1 PK analyte.

    Measured: 36 months

  8. Incidence of Anti-Drug Antibody (ADA) formation to PY159

    To evaluate the incidence of anti-drug antibody (ADA) formation to PY159

    Measured: 36 months

  9. Determining PY159 time to maximum concentration (Tmax)

    Determining PY159 time to maximum concentration (Tmax) during Cycle 1.

    Measured: 36 months

  10. Objective response rate (ORR)

    The incidents of ORR is defined as either a complete or partial response (PR) per RECIST. Subjects with no baseline data will be considered no responders. ORR will be summarized by dose, tumor type, and overall. ORR will be summarized descriptively.

    Measured: 36 months

  11. Clinical Benefit Rate (CBR)

    Defined as the percentage of subjects who have achieved complete response (CR), partial response (PR) and stable disease (SD).

    Measured: 36 months

  12. Duration of response (DOR)

    DOR will be calculated to determine durability. DOR will be measured from the time by which the criteria for CR or PR-whichever is recorded first-are met until the first date by which recurrent or progressive disease is objectively documented. DOR will be assessed using KAPLAN-MEIER methods.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start10 Nov 2020
  3. Primary completion25 Aug 2023
  4. Study completion31 Aug 2023

Why it stopped: Sponsor business decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model 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
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04682431
Sponsor's protocol ID
PY159-2-01
Status last verified
Mar 2024
First submitted
11 Dec 2020
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fan Y, Xu Y, Huo Z, Zhang H, Peng L, Jiang X, Thomson AW, Dai H. Role of triggering receptor expressed on myeloid cells-1 in kidney diseases: A biomarker and potential therapeutic target. Chin Med J (Engl). 2024 Jul 20;137(14):1663-1673. doi: 10.1097/CM9.0000000000003197. Epub 2024 May 28.

    PubMed 38809056

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PY159 Single agent dose level 1, PY159 Single agent dose level 2 and PY159 Single agent dose level 3 in people with Advanced Solid Tumor and Gynecologic Cancer, run by Ikena Oncology at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor business decision.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AE) (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04682431, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in