EP31670 for Advanced Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Epigenetix, Inc.
Must not be taking: Antibiotics, Antifungals
Disqualifiers: CNS metastasis, Heart failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
A Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
Will I have to stop taking my current medications?
The trial requires a four-week period without prior anti-cancer therapy, including chemotherapy, immunotherapy, or investigational anti-cancer therapy, before starting the study. This suggests you may need to stop certain medications, but the protocol does not specify all medications that must be stopped.
What safety data exists for EP31670 or similar treatments in humans?
Eligibility Criteria
This trial is for adults with certain advanced solid tumors, like prostate cancer or neuroendocrine tumors. Participants must be relatively healthy and active (ECOG 0-1), have a life expectancy of at least 3 months, and proper organ function. They should not have had recent cancer treatments or major surgery and must agree to use contraception. It's not for pregnant women, those with severe heart issues, uncontrolled illnesses, or specific viral infections.Inclusion Criteria
For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 4 weeks after the last dose of study drug
I am fully active or can carry out light work.
It has been at least 4 weeks since my major surgery.
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Exclusion Criteria
I am receiving antiviral treatment for hepatitis B or C.
Corrected QT interval ≥470 msec
Pregnant or lactating women
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive EP31670 in a dose-escalation study to determine the maximum tolerated dose
3 weeks per cycle
Multiple visits (in-person) per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Treatment Details
Interventions
- EP31670 (BET and CBP/p300 Inhibitor)
Trial OverviewEP31670 is being tested in this Phase 1 trial. It's a first-in-human study focusing on patients with targeted advanced solid tumors who may benefit from dual BET and CBP/p300 inhibition—a new approach aimed at stopping tumor growth by targeting specific proteins involved in cancer cell survival.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Part 3Experimental Treatment1 Intervention
Patients will be assigned escalated dose according to BOIN design. The starting dose is 10 mg orally once a day for 14 consecutive days in combination with ruxolitinib or momelotinib followed by 14 days of rest according to the traditional 3 + 3 design by the modified Fibonacci sequence
Group II: Part 2Experimental Treatment1 Intervention
Patients will be assigned escalated dose according to BOIN design. The starting dose is 20 mg orally once a day for 14 consecutive days followed by 14 days of rest.
Group III: Part 1Experimental Treatment1 Intervention
Patients will be assigned escalated dose according to BOIN design. The starting dose is 5 mg orally once a day for 7 consecutive days followed by 14 days of rest.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic ArizonaPhoenix, AZ
Mayo Clinic FloridaJacksonville, FL
Mayo Clinic RochesterRochester, MN
The University of Texas MD Anderson Cancer CenterHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Epigenetix, Inc.Lead Sponsor
References
Medication guide for dose adjustment and management of cardiotoxicity and lipid metabolic adverse events of oral antineoplastic therapy. [2023]The management of cardiotoxicity concerning the use of oral antineoplastic agents (OAAs) is a challenge for healthcare professionals. Our objective was to create a comprehensive medication management guide with dose adjustment recommendations on OAAs concerning cardiotoxic and lipid metabolic adverse events (AEs) to assist healthcare professionals when prescribing OAAs.
Cardiovascular adverse events associated with oral antineoplastic therapy. [2019]To identify in the literature the cardiovascular adverse events resulting from oral antineoplastic therapy.
Guiding pharmacist clinical interviews: a safety tool to support the education of patients treated with oral antineoplastic agents. [2016]Oral antineoplastic agents (OAA) lead to new challenges in patient education, monitoring, medication errors, drug interactions, adverse events management, and adherence. The aim is to develop a structured guide supporting pharmacist interviews and onco-hematologic outpatients' education process and to identify the key points that a pharmacist should address in order to increase OAA safety and efficacy.
Risks and benefits of anticancer drugs in advanced cancer patients: A systematic review and meta-analysis. [2022]Background: Randomized clinical trials (RCTs) of anticancer drugs without active comparators in patients who have exhausted standard of care treatment options are debated. We aimed to quantify the safety and the efficacy of anticancer drugs in advanced cancer patients who have exhausted standard of care treatments from RCTs without active comparators.Methods: This systematic review and meta-analysis was conducted according to preferred reporting Items for systematic review and Meta-Analyses (PRISMA) guidelines (CRD42021243968). A systematic literature search of English language publications from January 1, 2000, to January 7, 2021, was performed using MEDLINE (PubMed). Eligible trials included all RCTs evaluating anticancer drugs in adult patients with advanced solid tumors with a control arm without any anticancer drug consisting of best supportive care with or without a placebo. RCTs performed in the adjuvant, neoadjuvant or maintenance settings were excluded, as were clinical trials evaluating anticancer drugs in combination with radiotherapy. Two authors (C.M.B. and E.C.) independently reviewed the studies for inclusion. Data from published reports were extracted by investigators, and random-effects meta-analysis was performed to estimate the overall hazard ratios (HRs) of progression-free survival (PFS) and overall survival (OS). Correlations between severe toxicity and efficacy was assessed using R2 measures.Findings: Of 3551 studies screened, 128 eligible trials were found involving 47,432 patients. The HRs for PFS and OS were 0·58 [95%CI: 0·53-0·63] and 0·82 [95%CI: 0·78-0·85]. The absolute benefits however were limited with PFS and OS gains of 2·1 and 0·5 months. The absolute excesses in all grade, severe grade III, IV and V (death) adverse events between the two arms were +13·9%, 10·2%, and +0·5%. A weak correlation was measured between the excess of severe toxicity and efficacy (all R² < 0·2).Interpretation: Anticancer drugs evaluated in RCTs against no active treatment benefited trial participants. Severe toxicity did not significantly correlate with efficacy.
Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. [2023]Targeted therapies have revolutionized the treatment for many patients with non-small cell lung cancer (NSCLC). Multiple new oral targeted therapies have been approved in the last decade; however, their overall efficacy may be reduced by poor adherence, treatment interruptions, or dose reductions due to adverse events. Most institutions lack standard monitoring protocols for toxicities from these targeted agents. This review describes important adverse events observed in clinical trials and reported by the U.S. Food and Drug Administration for both currently approved and upcoming promising therapies in the treatment of NSCLC. These agents cause a range of toxicities, including dermatologic, gastroenteric, pulmonary, and cardiac toxicities. This review proposes protocols for routine monitoring of these adverse events, both prior to initiation of therapy and while on treatment.