A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

February 15, 2024 updated by: Constellation Pharmaceuticals

A Phase 1/2 Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Emerging evidence suggests that EZH2 is overexpressed in many cancer types and has a pivotal role in disease progression. This is a Phase 1/2, open-label, multi-center, FIH study designed to evaluate the safety and tolerability and preliminary clinical activity of CPI-0209, an EZH2/1 inhibitor as monotherapy in patients with advanced solid tumors and lymphomas. Phase 1 is composed of a CPI-0209 Dose Escalation period in patients with advanced tumors and aims to determine maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of CPI-0209 as monotherapy in patients with advanced tumors.

Phase 2 is planned to evaluate safety and tolerability and antitumor activity of CPI-0209 in six disease-specific cohorts (M1 to M6). Patients in Cohorts M1, M2, M3, M5, and M6 will be enrolled at 10 to 29 patients per cohort, using a Simon 2-stage design. Cohort M4 will enroll up to 20 patients with lymphoma in a single-stage. The primary aim of Phase 2 part of the study is to evaluate the antitumor activity of CPI-0209, and characterize the safety and tolerability of CPI-0209 as monotherapy in patients with selected tumors.

In Phase 2, two additional doses are planned to be evaluated in cohorts M2 and M3 in 2 stages: Stage 2a and Stage 2b. In Stage 2a approximately 20 patients will be enrolled per cohort and will be randomized 1:1 to receive 2 prespecified dose levels of CPI-0209 once daily. When protocol criteria for initiating Stage 2b will be fulfilled after completion of Stage 2a, then Stage 2b will be opened for enrolment of additional 10 patients in one or both dose arms in each of the two cohorts. Thus, up to 40 patients per cohort (M2 and M3) could be enrolled.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Bergonie Institute
        • Principal Investigator:
          • Antoine Italiano
        • Contact:
      • Lille, France, 59020
        • Recruiting
        • Oscar Lambret Center
        • Principal Investigator:
          • Cyril Abdeddaim
        • Contact:
      • Lyon, France, 69373
        • Recruiting
        • Leon Berard Center
        • Principal Investigator:
          • Mehdi Brahmi
        • Contact:
      • Nantes, France, 44093
        • Recruiting
        • Nantes University Hospital Center - Hotel Dieu Hospital
        • Principal Investigator:
          • Thomas Gastinne
        • Contact:
      • Nantes, France, 44093
        • Recruiting
        • Hospital North
        • Principal Investigator:
          • Thomas Gastinne, MD
        • Contact:
      • Nantes, France, 44093
        • Recruiting
        • Nantes University Hospital Center - Hotel Dieu Hospital (Satellite)
        • Principal Investigator:
          • Thomas Gastinne
        • Contact:
      • Strasbourg, France, 23025
        • Recruiting
        • Strasbourg Europe Institut of Cancerology
        • Principal Investigator:
          • Lauriane Eberst
        • Contact:
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy
        • Principal Investigator:
          • Vincent Ribrag, MD
        • Contact:
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Irccs University Hospital of Bologna
        • Principal Investigator:
          • Pier Luigi Zinzani, MD
        • Contact:
      • Milan, Italy, 20089
        • Recruiting
        • Gruppo Humanitas - Humanitas Research Hospital - Cancer Center
        • Contact:
        • Principal Investigator:
          • Carmelo Carlo-Stella
      • Rome, Italy, 00168
        • Recruiting
        • University Polyclinic Foundation "Agostino Gemelli" - IRCCS
        • Contact:
        • Principal Investigator:
          • Domenica Lorusso
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Principal Investigator:
          • Jae-Hoon Kim
        • Contact:
  • Poland
      • Lodz, Poland
        • Recruiting
        • Polish Mother's Memorial Hospital-Research Institute
        • Principal Investigator:
          • Ewa Kalinka
        • Contact:
      • Skorzewo,, Poland
        • Recruiting
        • Medical Center Pratia Poznan
        • Principal Investigator:
          • Marek Kotlarski, MD
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Maria Sklodowska-Curie - National Research Institute of Oncology
        • Principal Investigator:
          • Jan Walewski, MD
        • Contact:
  • Spain
      • Barcelona, Spain
        • Recruiting
        • University Hospital Vall d'Hebron
        • Principal Investigator:
          • Francesc Bosch Albareda
        • Contact:
        • Contact:
          • Albert Meire (Oncology)
          • Phone Number: 4691 +34 93 274 60 00
          • Email: ameire@vhio.net
      • Girona, Spain
        • Recruiting
        • University Hospital of Girona Dr. Josep Trueta
        • Principal Investigator:
          • Maria Pilar Barretina Ginesta
        • Contact:
      • Madrid, Spain
        • Recruiting
        • University Hospital 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Luis Manso Sanchez
      • Madrid, Spain
        • Recruiting
        • University Clinic of Navarra - Madrid
        • Contact:
          • Maria Aleman Ramos
          • Phone Number: +34 (91) 353 1920 Ext 7539
          • Email: maleman@unav.es
        • Principal Investigator:
          • Antonio Gonzalez Martin
      • Madrid, Spain
        • Recruiting
        • University Hospital Quiron Madrid
        • Principal Investigator:
          • Valentina Boni
        • Contact:
      • Palma De Mallorca, Spain
        • Recruiting
        • University Hospital Son Espases
        • Principal Investigator:
          • Jesus Alarcon
        • Contact:
      • Pamplona, Spain
        • Recruiting
        • University Clinic of Navarra - Pamplona
        • Contact:
          • Mercedes Egana Gorraiz
          • Phone Number: +34 (948) 255 400 Ext 2733
          • Email: megana@unav.es
        • Principal Investigator:
          • Ana Landa Magdalena
      • Seville, Spain
        • Recruiting
        • University Hospital Virgen del Rocio (HUVR)
        • Principal Investigator:
          • Alejandro Falcon Gonzalez
        • Contact:
      • Valencia, Spain
        • Recruiting
        • Valencia Oncology Institute (IVO)
        • Principal Investigator:
          • Angel Guerrero Zotano
        • Contact:
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Spain, 37007
        • Recruiting
        • University Clinical Hospital of Salamanca
        • Principal Investigator:
          • Martin Garcia-Sancho, MD, PhD
        • Contact:
    • Galicia
      • Santiago De Compostela, Galicia, Spain
        • Recruiting
        • University Hospital Complex of Santiago (CHUS)
        • Contact:
        • Principal Investigator:
          • Teresa Curiel Garcia
  • United Kingdom
      • Bath, United Kingdom
        • Recruiting
        • Royal United Hospital
        • Contact:
        • Principal Investigator:
          • Rebecca Bowen
      • Leicester, United Kingdom
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Principal Investigator:
          • Harriet Walter, MD
        • Contact:
      • Manchester, United Kingdom
        • Recruiting
        • The Christie NHS Foundation Trust, Department of Medical Oncology
        • Principal Investigator:
          • Andrew Clamp
        • Contact:
          • Amy Pearce
          • Phone Number: 0161 918 7688
      • Sutton, United Kingdom
        • Recruiting
        • Royal Marsden Hospital - Sutton
        • Principal Investigator:
          • Susana Banerjee
        • Contact:
      • Taunton, United Kingdom
        • Recruiting
        • Musgrove Park Hospital
        • Contact:
        • Principal Investigator:
          • Emma Cattell
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
        • Principal Investigator:
          • R. Donald Harvey, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Principal Investigator:
          • Hedy Kindler, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Completed
        • University of Maryland - Marlene and Stewart Greenebaum Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Ryan Sullivan, MD
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Alok Tewari, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Completed
        • University of Michigan Hospital
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • South Texas Accelerated Research Therapeutics (Start) - Midwest Location
        • Principal Investigator:
          • Nehal Lakhani, MD
        • Contact:
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
        • Principal Investigator:
          • Martin Gutierrez, MD
    • New York
      • Bronx, New York, United States, 10461
        • Completed
        • Montefiore Einstein Center for Cancer Care
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center - Laura and Isaac Perlmutter Cancer Center
        • Principal Investigator:
          • Salman Punekar, MD
        • Contact:
      • New York, New York, United States, 10065
        • Completed
        • Weill Medical College of Cornell University
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Completed
        • University of Cincinnati Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • South Texas Accelerated Research Therapeutics
        • Principal Investigator:
          • Drew Rasco, MD
        • Contact:
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia Health System
        • Principal Investigator:
          • Linda Duska, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute
        • Contact:
        • Principal Investigator:
          • Charles Drescher, MD
      • Seattle, Washington, United States, 98109-1023
        • Recruiting
        • Fred Hutchinson Cancer
        • Contact:
        • Principal Investigator:
          • Kalyan Banda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Phase 1

Eligible Phase 1 patients are adults who have a confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) that have relapsed following standard therapy or progressed through standard therapy or who have a disease for which no standard effective therapy exists.

Phase 2:

  • Life expectancy of ≥ 12 weeks
  • ECOG 0-1
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate liver function

For Cohort M1, the following criteria should be considered:

  • Histologically confirmed locally advanced unresectable or metastatic urothelial carcinoma with predominant urothelial histology
  • • Histologically confirmed metastatic solid tumor (except ovarian clear cell cancer, endometrial cancer, and pleural or peritoneal mesothelioma)
  • Known ARID1A mutation (NGS testing)
  • Disease progression during or following prior chemotherapy approved therapies or for which no standard therapy exists
  • Measurable disease per RECIST 1.1

For Cohort M2, the following criteria should be considered:

  • Histologically confirmed advanced ovarian clear cell carcinoma
  • Known ARID1A mutation (by NGS testing)
  • Received at least 1 line of platinum-based chemotherapy and must have received bevacizumab as part of any line of treatments unless contraindicated or locally not approved or locally not accessible
  • Measurable disease per RECIST 1.1
  • Patient must have disease progression after previously receiving effective and available standard of care treatment for clear cell ovarian cancer per local clinical practice

For Cohort M3, the following criteria should be considered:

  • Histologically or cytologically confirmed recurrent, metastatic, or unresectable endometrial carcinoma
  • Known ARID1A mutation (by NGS testing)
  • Received at least 1 line of platinum-based regimen in recurrent/metastatic setting
  • Documented microsatellite instability (MSI)-high or deficient mismatch repair (dMMR) or patients who have non-dMMR/microsatellite stable tumors should have received an anti-PD-1 or anti-PD-L1 agent alone or in combination with the approved agents as applicable, as part of their prior treatments unless considered not eligible, contraindicated or if not locally approved
  • Brachytherapy is allowed if completed >12 weeks before the first dose of study drug
  • Measurable disease per RECIST 1.1
  • Patients must have previously received effective and available standard of care treatment options for endometrial cancer per local clinical practice unless these are contraindicated

For Cohort M4, the following criteria should be considered:

  • PTCL or DLBCL with the following criteria:
  • PTCL
  • Documented refractory, relapsed, or progressive disease after at least 1 prior line of systemic therapy. Refractory is defined as:
  • Failure to achieve CR after first-line therapy
  • Failure to reach at least PR after second-line therapy or beyond
  • Must have at least 1 prior line of systemic therapy for PTCL.
  • Participants must be considered hematopoietic cell transplantation (HCT) ineligible during screening due to disease status (active disease), comorbidities, or other factors; the reason for HCT ineligibility must be clearly documented.
  • In the PTCL cohort, participants with anaplastic large cell lymphoma (ALCL) must have prior brentuximab vedotin treatment.
  • DLBCL:
  • Relapsed or refractory disease following 2 or more prior lines of standard therapy.
  • Not considered candidates to receive CAR-T or autologous hematopoietic stem cell transplant (ASCT) as assessed by the treating investigator for reasons such as age, underlying comorbidities, performance status, or due to disease progression after previously received ASCT or CAR-T. The reason for transplant ineligibility must be clearly documented.
  • For patients who underwent past ASCT or CAR-T treatment, at least 90 days must have elapsed since the start of the procedure. For all other patients, at least 8 weeks must have elapsed since their most recent systemic anti-DLBCL therapy

For Cohort M5, the following criteria should be considered:

  • Pleural or peritoneal relapsed/refractory mesothelioma
  • Must have progressed on or after at least 1 prior line of active therapy
  • Measurable disease per modified RECIST 1.1 for pleural mesothelioma or by RECIST 1.1 for peritoneal mesothelioma
  • Known BAP1 loss per immunohistochemistry (IHC) or NGS

For Cohort M6, the following criteria should be considered:

  • Have measurable soft-tissue disease
  • Documented metastatic disease
  • Disease progression while on prior therapies
  • Baseline testosterone ≤50 ng/dL (≤2.0 nM) and surgical or ongoing medical castration must be maintained throughout the duration of the study

Exclusion Criteria

Medical Conditions

  • Previous solid organ or allogeneic hematopoietic cell transplant (HCT)
  • Known symptomatic untreated brain metastases
  • Clinically significant cardiovascular disease
  • Major surgery within 4 weeks before starting study drug or not recovered from any effects of prior major surgery
  • Gastrointestinal disorders or any other condition that may significantly interfere with absorption of the study medication by Investigator's assessment.
  • Uncontrolled active infection requiring intravenous antibiotic, antiviral, or antifungal medications within 14 days before the first dose of study drug. Infections (eg, urinary tract infection) controlled on concurrent antimicrobial agents and antimicrobial prophylaxis per institutional guidelines are acceptable.
  • Suspected pneumonitis or interstitial lung disease or a history of pneumonitis or interstitial lung disease.
  • Have a history of a concurrent or second malignancy. Patients with a history of T-cell lymphoblastic lymphoma or T-Cell lymphoblastic leukemia are not eligible.
  • Have current known active or chronic infection with HIV, hepatitis B, or hepatitis C. Screening of patients with serologic testing for these viruses is not required
  • Clinically active or symptomatic viral hepatitis or chronic liver disease.
  • Unstable or severe uncontrolled medical condition or any important medical or psychiatric illness or abnormal laboratory finding
  • Previous solid organ or allogeneic hematopoietic cell transplant HCT.

Prior/Concomitant Therapy:

  • Prior anticancer treatment:

    • Prior systemic anticancer treatment with chemotherapy, targeted therapy, small molecule, antibody, or investigational anticancer therapy (includes prior PD-1 or PD-L1 therapy), or other anticancer therapeutic with the exception of gonadotropin releasing hormone analogues, within 4 weeks (or 5 half-lives), whichever is shorter, before the first dose of study drug (6 weeks washout for nitrosoureas or mitomycin C).
    • Previous treatment with an EZH2 inhibitor
    • Prior radiation therapy within 4 weeks before first dose of study drug
    • Prior stereotactic body radiation therapy within 2 weeks before first dose of study drug
    • Prior chemoembolization or radioembolization within 4 weeks before first dose of study drug.
  • Concomitant medication(s) or food or beverage that are strong CYP3A inducers or inhibitors within 7 days prior to the first dose of study drug.

Other Exclusions

• Breastfeeding or pregnant woman or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 183 days after the last dose of study drug.

Cohort M6 (mCRPC) only

  • Bone-only disease without nodal disease and no evidence of visceral spread
  • Structurally unstable bone lesions concerning for impending fracture
  • Herbal products that may decrease prostate-specific antigen within 4 weeks prior to Day 1 of treatment and while on study
  • Treatment for prostate cancer (First generation androgen receptor antagonists within 4 weeks; 5α-reductase inhibitors, ketoconazole, estrogens, or progesterones within 2 weeks)
  • Planned palliative procedures such as radiation therapy or surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 2 Cohort M1

CPI-0209 will be dosed once per day orally in 28 day cycles.

• Cohort M1: patients with urothelial carcinoma or other advanced/metastatic solid tumors (with known ARID1A mutation)
Drug: CPI-0209
CPI-0209 alone
Experimental: Phase 2 Cohort M2

CPI-0209 will be dosed once per day orally in 28 day cycles.

• Cohort M2 patients with ovarian clear cell carcinoma (with known ARID1A mutation)
Drug: CPI-0209
CPI-0209 alone
Experimental: Phase 2 Cohort M3

CPI-0209 will be dosed once per day orally in 28 day cycles.

• Cohort M3 patients with endometrial carcinoma (with known ARID1A mutation)
Drug: CPI-0209
CPI-0209 alone
Experimental: Phase 2 Cohort M4

CPI-0209 will be dosed once per day orally in 28 day cycles.

• Cohort M4 patients with peripheral T-cell lymphoma (PTCL) and patients with diffuse large B-cell lymphoma (DLBCL), including patients with documented germinal center B cell like diffuse large B-cell lymphoma (GCB-DLBCL) with at least 1 EZH2 hotspot mutation
Drug: CPI-0209
CPI-0209 alone
Experimental: Phase 2 Cohort M5

CPI-0209 will be dosed once per day orally in 28 day cycles.

• Cohort M5 patients with relapsed or refractory malignant pleural or peritoneal mesothelioma with known BAP1 loss
Drug: CPI-0209
CPI-0209 alone
Experimental: Phase 2 Cohort M6

CPI-0209 will be dosed once per day orally in 28 day cycles.

• Cohort M6 patients with castration-resistant prostate cancer(mCRPC) with measurable soft tissue disease
Drug: CPI-0209
CPI-0209 alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Frequency of Dose-limiting toxicities (DLTs)
Time Frame: DLTs assessed during Cycle 1 (first 28 days on study)
The maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of CPI-0209 in patients with advanced tumors
DLTs assessed during Cycle 1 (first 28 days on study)
Phase 2: Overall response rate (ORR)
Time Frame: 18 months
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) based on RECIST 1.1 or applicable response criteria
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 Adverse events (AEs) and change in laboratory values
Time Frame: 18 months
18 months
Phase 1: PK parameters
Time Frame: 18 months
Cmax
18 months
Phase 1: PK parameters
Time Frame: 18 months
Tmax
18 months
Phase 1: PK parameters
Time Frame: 18 months
AUC0-last
18 months
Phase 1: PK parameters
Time Frame: 18 months
AUC0-Inf
18 months
Phase 1: PK parameters
Time Frame: 18 months
t1/2
18 months
Phase 1: PK parameters
Time Frame: 18 months
Cmin
18 months
Phase 1: PD parameters
Time Frame: 18 months
Gene expression in blood cells
18 months
Phase 1: PD parameters
Time Frame: 18 months
H3K27me3
18 months
Phase 1: ORR
Time Frame: 18 months
ORR, defined as proportion of patients with a best overall response of CR or PR) based on RECIST 1.1 or applicable response criteria
18 months
Phase 1: ORR per Gynecologic Cancer
Time Frame: 18 months
ORR per Gynecologic Cancer Intergroup (GCIG)-defined CA-125 response criteria (ovarian cancer patients)
18 months
Phase 1: ORR per prostate cancer
Time Frame: 18 months
ORR per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
18 months
Phase 1: Progression-free survival (PFS)
Time Frame: 18 months
PFS, defined as the time from first dose to confirmed disease progression or death
18 months
Phase 1: Duration of response (DOR)
Time Frame: 18 months
DOR, defined as the time from the date of first response to the date of confirmed disease progression
18 months
Phase 1: Time to response (TTR)
Time Frame: 18 months
Time to response, defined as the time from first dose to date of first response
18 months
Phase 1: Disease control rate
Time Frame: 18 months
[Disease control rate, defined as the proportion of patients with a best overall response of CR, PR, or stable disease
18 months
Phase 2: PFS
Time Frame: 30 months
PFS, defined as the time from first dose to confirmed disease progression or death
30 months
Phase 2: Time-to-progression
Time Frame: 30 months
Time-to-progression (TTP)
30 months
Phase 2: DOR
Time Frame: 30 months
DOR, defined as the time from the date of first response to the date of confirmed disease progression
30 months
Phase 2: TTR
Time Frame: 30 months
TTR, defined as the time from first dose to date of first response
30 months
Phase 2: Disease control rate
Time Frame: 30 months
Disease control rate, defined as the proportion of patients with a best overall response of CR, PR or SD per cohort and CPI-0209 dose level
30 months
Phase 2: ORR
Time Frame: 30 months
ORR per GCIG-defined CA-125 response criteria (ovarian cancer patients)
30 months
Phase 2: Overall survival (OS)
Time Frame: 30 months
OS, defined as the time from first dose to death
30 months
Phase 2: Incidences of AEs
Time Frame: 30 months
Number of Participants With Adverse Events (AEs)
30 months
Phase 2: PK parameters
Time Frame: 30 months
Cmax
30 months
Phase 2: PK parameters
Time Frame: 30 months
Tmax
30 months
Phase 2: PK parameters
Time Frame: 30 months
AUC0-last
30 months
Phase 2: PK parameters
Time Frame: 30 months
AUC0-inf
30 months
Phase 2: PK parameters
Time Frame: 30 months
T1/2
30 months
Phase 2: PK parameters
Time Frame: 30 months
Cmin
30 months
Phase 2: PD parameters
Time Frame: 30 months
Gene expression in blood cells
30 months
Phase 2: PD parameters
Time Frame: 30 months
H3K27me3 levels
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Constellation Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI-0209-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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