CPI-0209 for Cancer and Lymphoma

Recruiting at 65 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Constellation Pharmaceuticals

Must be taking: Gonadotropin analogues

Must not be taking: EZH2 inhibitors, CYP3A inducers

Disqualifiers: Transplant, Brain metastases, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 29

Duration: 30 months

275 Participants Needed

Trial Summary

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.

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.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Phase 2 Cohort M8 Experimental Treatment 2 Interventions

Tulmimetostat will be dosed once per day orally in 28-day cycles in combination with enzalutamide. • Cohort M8 patients with castration-resistant prostate cancer (mCRPC).

Group II: Phase 2 Cohort M7 Experimental Treatment 1 Intervention

Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M7 food effect in patients with ARID1A wildtype (ARID1A WT) endometrial carcinoma

Group III: Phase 2 Cohort M6 Experimental Treatment 1 Intervention

Tulmimetostat 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 IV: Phase 2 Cohort M5 Experimental Treatment 1 Intervention

Tulmimetostat 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 V: Phase 2 Cohort M4 Experimental Treatment 1 Intervention

Tulmimetostat 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 Enhancer of Zeste Homolog 2 (EZH2) hotspot mutation

Group VI: Phase 2 Cohort M3 Experimental Treatment 1 Intervention

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

Group VII: Phase 2 Cohort M2 Experimental Treatment 1 Intervention

Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M2 patients with ovarian clear cell carcinoma (with known ARID1A mutation)

Group VIII: Phase 2 Cohort M1 Experimental Treatment 1 Intervention

Tulmimetostat 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)

Group IX: Phase 1 Cohort M8 Experimental Treatment 1 Intervention

Tulmimetostat will be dosed once per day orally in combination with enzalutamide Cohort M8 patients with castration-resistant prostate cancer (mCRPC).

Group X: Phase 1 Experimental Treatment 1 Intervention

Tulmimetostat will be dosed once per day orally in patients with advanced tumors.

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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD