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Small Molecule Inhibitor

CPI-0209 for Cancer and Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Constellation Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort M5: Pleural or peritoneal relapsed/refractory mesothelioma, 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

Cohort M2: Histologically confirmed advanced ovarian clear cell carcinoma, known ARID1A mutation, received at least 1 line of platinum-based chemotherapy, measurable disease per RECIST 1.1, disease progression after previously receiving effective and available standard of care treatment for clear cell ovarian cancer per local clinical practice

Must not have

Clinically active or symptomatic viral hepatitis or chronic liver disease

Suspected pneumonitis or interstitial lung disease or a history of pneumonitis or interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, CPI-0209, to see if it's safe and effective in treating patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions seen with other similar drugs such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver function abnormalities, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My mesothelioma has returned or didn't respond to treatment, and it shows BAP1 loss.

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I have advanced ovarian clear cell cancer with an ARID1A mutation, have had platinum-based chemotherapy, and my cancer has progressed after standard treatments.

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My cancer has spread, is growing despite treatment, and I'm undergoing hormone therapy to lower testosterone.

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My advanced cancer has not responded to standard treatments.

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I am expected to live more than 12 weeks, can move around well, and my kidneys, liver, and bone marrow are functioning properly.

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My cancer is advanced bladder cancer with a specific mutation and has worsened despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active symptoms of hepatitis or chronic liver disease.

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I have or might have lung inflammation or scarring.

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I have a serious heart condition.

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I haven't had major surgery in the last 4 weeks or still recovering from one.

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I have had a transplant of an organ or bone marrow.

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I haven't taken strong CYP3A affecting drugs or consumed related foods or beverages in the last 7 days.

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I do not have any severe uncontrolled health conditions or serious psychiatric illnesses.

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I have been treated with an EZH2 inhibitor before.

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I have brain metastases that haven't been treated and are causing symptoms.

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I do not have an active or chronic infection with HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Phase 2: Overall response rate (ORR)

Secondary study objectives

Phase 1: Disease control rate

Phase 1: Duration of response (DOR)

Phase 1: ORR

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2 Cohort M6Experimental Treatment1 Intervention

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

Group II: Phase 2 Cohort M5Experimental Treatment1 Intervention

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

Group III: Phase 2 Cohort M4Experimental Treatment1 Intervention

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

Group IV: Phase 2 Cohort M3Experimental Treatment1 Intervention

CPI-0209 will be dosed once per day orally in 28 day cycles. • Cohort M3 patients with endometrial carcinoma (with known ARID1A mutation)

Group V: Phase 2 Cohort M2Experimental Treatment1 Intervention

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)

Group VI: Phase 2 Cohort M1Experimental Treatment1 Intervention

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)

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