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Translation Inhibitor
Zotatifin for Solid Tumors (Zotatifin Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Effector Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Maximum of five prior lines of therapy for advanced/metastatic disease.
Patient has histological or cytological confirmation of breast cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 12 months
Awards & highlights
Zotatifin Trial Summary
This trial is testing a new cancer drug, Zotatifin, to see if it is safe and effective. Treatment and evaluations will be done every 21 days.
Who is the study for?
This trial is for adults with certain advanced solid tumors who've had previous treatments like CDK4/6 inhibitors and are now facing cancer that's resistant or intolerant to standard therapies. They should have tried at least one, but no more than five lines of therapy for metastatic disease, and specific criteria apply based on the type of tumor (ER+, HER2-, KRAS mutation, etc.).Check my eligibility
What is being tested?
The study tests Zotatifin (eFT226) alongside other drugs like Abemaciclib, Fulvestrant, Trastuzumab, and Sotorasib in a Phase 1-2 trial. It aims to find out how safe eFT226 is and how it affects the body (pharmacokinetics/dynamics) as well as its effectiveness against various solid tumors.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer treatments such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems. Specific drug-related side effects will be monitored closely due to the investigational nature of Zotatifin.
Zotatifin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had no more than five treatments for my advanced cancer.
Select...
My breast cancer diagnosis was confirmed through lab tests.
Select...
I have been treated with a CDK4/6 inhibitor before.
Select...
My tumor has a KRAS mutation, but not the G12C type.
Select...
My tumor is estrogen receptor positive and not HER2 positive.
Select...
I have been treated with platinum-based chemotherapy and anti-PD-1/L1 therapy.
Select...
My tumor is estrogen receptor positive.
Select...
My tumor is estrogen receptor positive.
Select...
My cancer has spread or returned and doesn't respond to current treatments.
Select...
My tumor shows high levels of Cyclin D1.
Select...
My cancer has worsened after receiving a HER2-targeted therapy and chemotherapy.
Select...
My lung cancer is at an advanced stage with fluid buildup or has spread.
Select...
My cancer returned or worsened after hormone therapy for advanced disease.
Select...
My tumor is estrogen receptor positive and has FGFR amplification.
Select...
My tumor is positive for both estrogen receptors and HER2.
Select...
My tumor has a specific KRAS mutation, and I haven't had KRAS-targeted therapy.
Select...
I have received at least one treatment for my advanced cancer.
Zotatifin Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 2: (Combination Cohorts) Determine MTD
Part 2: (Combination Cohorts) Determine RP2D
Part 2: (Combination Cohorts) Incidence, type, and severity of AEs and SAEs
+7 moreSecondary outcome measures
Evaluate plasma Pharmacokinetic (PK) parameters of eFT226
Evaluate plasma Pharmacokinetic (PK) parameters of eFT226 including terminal phase rate constant
DNA Nucleotidylexotransferase
+7 moreZotatifin Trial Design
11Treatment groups
Experimental Treatment
Group I: Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)Experimental Treatment1 Intervention
Cohort EMNK
Group II: Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)Experimental Treatment1 Intervention
Cohort EMBH
Group III: Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)Experimental Treatment1 Intervention
Cohort EMBF
Group IV: Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)Experimental Treatment1 Intervention
Cohort ECNS; Combination therapy partner administered per SOC at the approved dose.
Group V: Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)Experimental Treatment1 Intervention
Cohort ECBT; Combination therapy partner administered per SOC at the approved dose.
Group VI: Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)Experimental Treatment2 Interventions
Cohort ECBF+A; Combination therapy partner administered per SOC at the approved dose.
Group VII: Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)Experimental Treatment1 Intervention
Cohort ECBF; Combination therapy partner administered per SOC at the approved dose.
Group VIII: Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1Experimental Treatment1 Intervention
ECBF-D1; Combination therapy partner administered per SOC at the approved dose.
Group IX: Part 1b Dose Escalation, Combination, BreastExperimental Treatment1 Intervention
eFT226 administered IV every other week in 14-day cycles. Fulvestrant will also be given. Dose escalations per protocol.
Group X: Part 1a: Dose Escalation, Combination, BreastExperimental Treatment1 Intervention
eFT226 administered IV weekly in 21-day cycles. Fulvestrant will also be given. Dose escalations per protocol.
Group XI: Part 1: Sequential escalation (Completed)Experimental Treatment1 Intervention
eFT226 administered IV weekly in 21-day cycles; dose escalated in sequential cohorts after subjects enrolled in a given cohort have completed DLT evaluation period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved
Abemaciclib
FDA approved
Trastuzumab
FDA approved
Sotorasib
FDA approved
Find a Location
Who is running the clinical trial?
Effector TherapeuticsLead Sponsor
9 Previous Clinical Trials
443 Total Patients Enrolled
Robert Sikorski, MDStudy DirectorEffector Therapeutics
Douglas Warner, MDStudy DirectorEFFECTOR Therapeutics, Inc.
2 Previous Clinical Trials
216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had at least one HER2-targeted treatment.I have had no more than five treatments for my advanced cancer.My breast cancer diagnosis was confirmed through lab tests.My tumor is HER2 positive with no limit on previous hormone treatments.I have been treated with a CDK4/6 inhibitor before.I have previously undergone chemotherapy, hormone therapy, or other treatments.My tumor has a KRAS mutation, but not the G12C type.My tumor is estrogen receptor positive and not HER2 positive.I have been treated with platinum-based chemotherapy and anti-PD-1/L1 therapy.My tumor is estrogen receptor positive.My tumor is estrogen receptor positive.My cancer has spread or returned and doesn't respond to current treatments.My tumor shows high levels of Cyclin D1.My cancer has worsened after receiving a HER2-targeted therapy and chemotherapy.I have been treated with platinum chemotherapy and anti-PD-1/L1, if it was suitable for me.My lung cancer is at an advanced stage with fluid buildup or has spread.My cancer returned or worsened after hormone therapy for advanced disease.My tumor is estrogen receptor positive and has FGFR amplification.My tumor is positive for both estrogen receptors and HER2.My tumor has a specific KRAS mutation, and I haven't had KRAS-targeted therapy.I have received at least one treatment for my advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)
- Group 2: Part 1a: Dose Escalation, Combination, Breast
- Group 3: Part 1b Dose Escalation, Combination, Breast
- Group 4: Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1
- Group 5: Part 1: Sequential escalation (Completed)
- Group 6: Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)
- Group 7: Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)
- Group 8: Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)
- Group 9: Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)
- Group 10: Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)
- Group 11: Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are administering this clinical trial?
"The 17 clinical trial sites for this study can be found in locations such as Commack, New york City and Newport Beach. These centres include Memorial Sloan Kettering Cancer Center, David H. Koch Center for Cancer Care, Hoag Memorial Hospital Presbyterian and several other medical facilities."
Answered by AI
What major goals does this research endeavor aim to achieve?
"This clinical trial will monitor a primary outcome over the 12-month study period: the incidence of treatment-emergent adverse events (safety and tolerability). Additionally, secondary outcomes such as plasma pharmacokinetic parameters of eFT226 including total body clearance, duration of response, and terminal state volume of distribution will be evaluated."
Answered by AI
To what extent is participation being sought for this medical experiment?
"To adequately power the trial, 228 patients who meet the specified inclusion criteria will need to be recruited. Potential participants can find a clinical site in Commack, New york and another one at David H. Koch Center for Cancer Care in Texas."
Answered by AI
Can new participants join this experiment?
"Clinicialtrials.gov documents confirm that this investigation is actively recruiting participants, which was first announced on October 25th 2019 and most recently updated on November 15 2022."
Answered by AI
Has eFT226 been tested in similar experiments before?
"Presently, there are 2 ongoing clinical trials for eFT226 with none in the final phase. These studies are primarily based out of Cullman, Alabama though 24 other medical centres also have active research initiatives."
Answered by AI
Has this research been pioneered before?
"Since 2019, research into eFT226 has been ongoing. The first clinical trial was completed in that year, organized by Effector Therapeutics and involving 228 participants. Following this initial study, Phase 1 & 2 drug approval for the medication was granted. Presently there are two active trials of eFT226 being conducted across 19 cities in a single country."
Answered by AI
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