275 Participants Needed

CPI-0209 for Cancer and Lymphoma

Recruiting at 65 trial locations
C0
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Constellation Pharmaceuticals
Must be taking: Gonadotropin analogues
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, and preliminary clinical activity of Tulmimetostat as a monotherapy in patients with advanced solid tumors and lymphomas.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for prior systemic anticancer treatments, which must be stopped at least 4 weeks before the first dose of the study drug. Additionally, you must avoid medications or foods that are strong CYP3A inducers or inhibitors within 7 days prior to starting the study drug. Please consult with the trial team for specific guidance on your current medications.

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with various advanced cancers, including ovarian, endometrial, mesothelioma, prostate cancer and lymphomas. Participants must have a life expectancy of at least 12 weeks and be in good physical condition (ECOG 0-1). They should have tried standard treatments without success and meet specific criteria like certain genetic mutations or hormone levels depending on the cancer type.

Inclusion Criteria

I have PTCL or DLBCL, my treatment hasn't worked, and I can't have a transplant.
My mesothelioma has returned or didn't respond to treatment, and it shows BAP1 loss.
I have advanced ovarian clear cell cancer with an ARID1A mutation, have had platinum-based chemotherapy, and my cancer has progressed after standard treatments.
See 5 more

Exclusion Criteria

I have active symptoms of hepatitis or chronic liver disease.
I have or might have lung inflammation or scarring.
I don't have stomach issues affecting my medication absorption.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Phase 1 involves a dose escalation period to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of CPI-0209 as monotherapy in patients with advanced tumors.

28 days
Cycle 1 (first 28 days on study)

Treatment

Phase 2 evaluates the safety, tolerability, and antitumor activity of CPI-0209 in six disease-specific cohorts with 28-day cycles.

30 months
28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to response and progression-free survival.

18-30 months

What Are the Treatments Tested in This Trial?

Interventions

  • CPI-0209
Trial Overview CPI-0209 is being tested; it's a new drug that targets EZH2, an enzyme involved in cancer growth. The study has two phases: dose escalation to find the safe dosage level and expansion to test its effectiveness across different types of advanced solid tumors and lymphomas.
How Is the Trial Designed?
10Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort M8Experimental Treatment2 Interventions
Group II: Phase 2 Cohort M7Experimental Treatment1 Intervention
Group III: Phase 2 Cohort M6Experimental Treatment1 Intervention
Group IV: Phase 2 Cohort M5Experimental Treatment1 Intervention
Group V: Phase 2 Cohort M4Experimental Treatment1 Intervention
Group VI: Phase 2 Cohort M3Experimental Treatment1 Intervention
Group VII: Phase 2 Cohort M2Experimental Treatment1 Intervention
Group VIII: Phase 2 Cohort M1Experimental Treatment1 Intervention
Group IX: Phase 1 Cohort M8Experimental Treatment1 Intervention
Group X: Phase 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Constellation Pharmaceuticals

Lead Sponsor

Trials
10
Recruited
1,500+

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

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