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Advanced Solid TumorsPhase 1NCT03525795

ORIOn-E: A Study Evaluating CPI-1205 in Patients With Advanced Solid Tumors

A Phase 1 study testing CPI-1205 and ipilimumab in people with Advanced Solid Tumors, run by Constellation Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
CPI-1205 and ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesUnited States
Study dates
14 Dec 2017to 12 Jun 2019
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

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Diagnosis and Prior Treatment:
  • Phase 1: Patients with histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors and with progressive disease during or after treatment with a PD-1 or PD-L1-inhibitor who meet one of the following criteria:
  • Relapsed following or progressed through standard therapy
  • Have a disease for which no standard effective therapy exists (i.e., a therapy that demonstrates a significant increase in survival)
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  • Not a candidate for standard effective therapy NOTE: In men with prostate cancer, baseline testosterone levels must also be ≤50ng/dL (≤ 2.0nM) and surgical or ongoing medical castration must be maintained throughout the duration of the study.
  • Phase 2: Patients with histologically or cytologically confirmed diagnosis of one of the following and with progressive disease during or after treatment with a PD-1 or PD-L1-inhibitor:
  • Cohort A: unresectable or metastatic melanoma
  • Cohort B: metastatic NSCLC
  • Cohort C: advanced or metastatic (stage 4) RCC
  • Cohort D: unresectable or metastatic urothelial carcinoma (urethra, bladder, ureters, or renal pelvis)
  • If patient has known brain metastases, must have stable neurologic status following local therapy for at least 4 weeks without the use of steroids or on stable or decreasing dose of ≤10 mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs).
  • Phase 1: patients may have measurable or non-measurable disease; measurable disease via RECIST 1.1 is required for Phase 2 patients
  • Recovery from recent surgery, radiotherapy, chemotherapy or any other anti-cancer therapy to baseline or ≤ Grade 1 (other than alopecia); ≤ Grade 2 neuropathy allowed
  • Demonstrate adequate organ function
  • Ability to swallow and retain oral medications

Who cannot join

  • Carcinomatous meningitis
  • Prior treatment with CTLA-4 inhibitor
  • Phase 2 Cohort: ocular melanoma
  • Experienced an immune-related adverse event (irAE) that led to permanent discontinuation of prior immunotherapy
  • History of severe hypersensitivity reaction to treatment with another monoclonal antibody
  • History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; NOTE: history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
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  • Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Known history of human immunodeficiency virus (HIV) (HIV1/2 antibodies)
  • Gastrointestinal (GI) disorder that negatively affects absorption

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • START Midwest

    Grand Rapids, Michigan, 49546

  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1 Study of CPI-1205 With Ipilimumab in Patients With Advanced Solid Tumors Followed by a Phase 2 Basket Study of CPI-1205 With Ipilimumab in Selected Tumor Types Previously Treated With PD-1 or PD-L1 Inhibitors

This is a Phase 1/2, multi-center, open-label study of CPI-1205 + ipilimumab in patients with histologically or cytologically confirmed advanced solid tumors. This study is designed to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of CPI-1205 + ipilimumab in patients with advanced solid tumors. Patients in Phase 2 will be treated at the RP2D of CPI-1205 + ipilimumab.

This study was stopped prior to proceeding to Phase 2; no patients were enrolled in Phase 2.

Being tested
CPI-1205, ipilimumab
Keywords
Phase 1/2, Oncology, EZH2 Inhibitor
Medical subject headings
Neoplasms

What participants receive

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

  • CPI-1205Drug

    Administered orally

  • ipilimumabDrug

    Administered intravenously

Study groups in NCT03525795
Study groupRoleWhat they receive
CPI-1205 Combination with ipilimumabExperimentalNot described
Receives: Drug: CPI-1205; Drug: ipilimumab

What is being measured

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

  1. Phase 1: Frequency of Dose-limiting toxicities (DLTs)

    The RP2D will be selected based on the PK, pharmacodynamics and overall tolerability of the regimen, but will not exceed the MTD.

    Measured: 1 year

  2. Phase 2: Objective response rate

    The rate of confirmed complete responses (CR) + partial responses (PR) as determined by RECIST 1.1 criteria

    Measured: 1 year

Secondary outcomes (7)

  1. Objective response rate

    The rate of confirmed iCR + iPR

    Measured: 1 year

  2. Clinical Benefit Rate

    The rate of CR + PR + stable disease (SD) after 3 months of treatment as determined by RECIST 1.1 criteria and as the rate of iCR + iPR + iSD after 3 months of treatment by iRECIST criteria

    Measured: 3 months

  3. Time to response

    The time from day (D) 1 of treatment to the date of first response as determined by RECIST 1.1 and iRECIST criteria

    Measured: 1 year

  4. Duration of Response

    The time from measurement criteria are first met for CR/PR or iCR/iPR (whichever is first recorded) until the date of recurrence or progressive disease as determined by RECIST 1.1 and iRECIST criteria

    Measured: 1 year

  5. Duration of treatment

    The time from D1 of treatment until the date treatment is discontinued for any reason

    Measured: 1 year

  6. Progression free survival

    The time from D1 of treatment to the date of progression or death, whichever occurs first with progressive disease as determined by RECIST 1.1 and iRECIST criteria

    Measured: 6 months

  7. Adverse Events

    AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).

    Measured: 1 year

Timeline

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

  1. First posted16 May 2018
  2. Study start14 Dec 2017
  3. Primary completion12 Jun 2019
  4. Study completion12 Jun 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525795
Sponsor's protocol ID
1205-202
Status last verified
May 2022
First submitted
23 Apr 2018
Last updated
18 May 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CPI-1205 and ipilimumab in people with Advanced Solid Tumors, run by Constellation Pharmaceuticals at 3 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 17 inclusion and 9 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: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase 1: Frequency of Dose-limiting toxicities (DLTs) (time frame: 1 year). 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 NCT03525795.

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 18 May 2022.

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