CPI-0209 for Cancer and Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Tulmimetostat (also known as CPI-0209) for individuals with advanced solid tumors and lymphomas. The goal is to assess the safety and effectiveness of this medication when used alone or with other drugs across various cancer types. It suits those whose cancer has returned or hasn't responded to standard treatments, such as prostate cancer unresponsive to hormone therapy or specific genetic mutations. Participants will take Tulmimetostat daily, and some groups will also take another drug, enzalutamide. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Tulmimetostat, also known as CPI-0209, is generally safe. Studies found that doses of 200 mg and 300 mg are usually well-tolerated by patients with ovarian clear cell carcinoma and endometrial carcinoma, while a higher dose of 350 mg caused more side effects.
Tulmimetostat's safety profile is similar to other treatments targeting the EZH2 protein, which aids cell growth, meaning its side effects resemble those of other drugs in the same group.
In early trials, even patients with extensive prior treatments tolerated Tulmimetostat well. This is encouraging, as these patients often have limited treatment options. While side effects may occur, current evidence suggests that Tulmimetostat is safe for use in human studies.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Tulmimetostat because it targets the Enhancer of Zeste Homolog 2 (EZH2) enzyme, which plays a crucial role in regulating gene expression in cancer cells. Unlike traditional chemotherapy, which broadly attacks rapidly dividing cells, Tulmimetostat specifically inhibits EZH2, potentially leading to fewer side effects and more precise targeting of cancerous cells. Its oral administration makes it more convenient compared to many standard treatments that require intravenous delivery. This targeted approach, combined with ease of use, offers a promising new avenue for treating various cancers, including lymphoma and advanced solid tumors.
What evidence suggests that CPI-0209 might be an effective treatment for cancer and lymphoma?
Research has shown that Tulmimetostat, also known as CPI-0209, holds promise in treating various types of cancer. In this trial, participants will receive Tulmimetostat in different cohorts, each targeting specific cancer types. Earlier studies found that patients with a type of prostate cancer unresponsive to hormone therapy experienced stable disease, meaning their cancer did not worsen. Additionally, patients with endometrial cancer and certain genetic changes showed positive responses. This drug blocks proteins called EZH2/EZH1, which can promote cancer growth. Early results suggest that targeting these proteins might slow or stop tumor growth in certain cancers. Although more research is needed, these findings are encouraging.13467
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Treatment
Phase 2 evaluates the safety, tolerability, and antitumor activity of CPI-0209 in six disease-specific cohorts with 28-day cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including time to response and progression-free survival.
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?
10
Treatment groups
Experimental Treatment
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).
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
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
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
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
Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M3 patients with endometrial carcinoma (with known ARID1A mutation)
Tulmimetostat will be dosed once per day orally in 28 day cycles. • Cohort M2 patients with ovarian clear cell carcinoma (with known ARID1A mutation)
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)
Tulmimetostat will be dosed once per day orally in combination with enzalutamide Cohort M8 patients with castration-resistant prostate cancer (mCRPC).
Tulmimetostat will be dosed once per day orally in patients with advanced tumors.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Constellation Pharmaceuticals
Lead Sponsor
Novartis Pharmaceuticals
Lead Sponsor
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
Citations
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients ...
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 ...
EZH2/EZH1 inhibitor tulmimetostat (CPI-0209) in patients ...
Results: As of Nov 08, 2022, 62 pts received ≥1 dose (safety evaluable); 48 had ≥1 postbaseline tumor assessment (efficacy evaluable). Pts had ...
EZH2/EZH1 inhibitor tulmimetostat (CPI-0209) in patients ...
Results: As of Nov 08, 2022, 62 pts received ≥1 dose (safety evaluable); 48 had ≥1 postbaseline tumor assessment (efficacy evaluable). Pts had median 3.2 years ...
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients ...
Of the eight evaluable patients with metastatic castration-resistant prostate cancer, five had stable disease. Of the four evaluable patients with endometrial ...
A Phase 1/2 Study of DZR123 (CPI-0209) in Patients With ...
Eligible Phase 1 patients are adults who have a confirmed locally advanced or metastatic tumors (solid tumors or lymphoma) that have relapsed ...
Phase II dose optimization update with EZH2/EZH1 ...
Tulmimetostat showed an improved and acceptable safety profile in OCCC and EC at 200 mg and 300 mg doses (versus 350 mg) with promising antitumor activity.
Tulmimetostat
Tulmimetostat (also known as CPI-0209 or DZR123) is an orally available, investigational antineoplastic drug being developed for the treatment of various ...
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