CPI-0209 for Cancer and Lymphoma
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
Exclusion Criteria
Timeline
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.
Treatment Details
Interventions
- CPI-0209
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