eFT226 for Solid Tumors, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Solid Tumors, AdulteFT226 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

20 Primary · 11 Secondary · Reporting Duration: From start of study therapy to the first documentation of disease progression or death from any cause, which ever came first, assessed up to 100 months

Month 100
antitumor activity and survival
Month 12
Evaluate plasma Pharmacokinetic (PK) parameters of eFT226
Evaluate plasma Pharmacokinetic (PK) parameters of eFT226 including terminal phase rate constant
DNA Nucleotidylexotransferase
Part 2: (Combination Cohorts) Determine MTD
Part 2: (Combination Cohorts) Determine RP2D
Part 2: (Combination Cohorts) Incidence, type, and severity of AEs and SAEs
Combined Modality Therapy
Part 2: Duration of Response (DOR)- Efficacy
Part 2: Objective Response Rate- Efficacy
Neoplasms
Part 2: Progression Free Survival
Part 2: Time to Response (TTR)- Efficacy
Parts 1a and 1b: DOR
Parts 1a and 1b: MTD
Parts 1a and 1b: Objective response
Parts 1a and 1b: PFS
Neoplasms
Parts 1a and 1b: RP2D
Parts 1a and 1b: TTR
Parts 1a and 1b; incidence of AEs, serious adverse events (SAEs), and DLTs
Month 12
Duration of Response (DOR)- Efficacy
Establish Maximum Tolerated Dose (MTD) as determined by occurrence of first cycle Dose Limiting Toxicity (DLT)
Establish Recommended Phase 2 Dose (RP2D)
Incidence of Treatment-emergent adverse events (safety and tolerability)
Incidence of serious adverse events (safety and tolerability)
Percent change in tumor dimensions of target lesions- Efficacy
Time to Response (TTR)- Efficacy
evaluate plasma PK parameters of eFT226 - Area under the plasma concentration -time curve (AUC)
evaluate plasma PK parameters of eFT226 - maximum concentration (Cmax)
evaluate plasma PK parameters of eFT226 - terminal phase half-life (t1/2)

Trial Safety

Safety Progress

1 of 3

Trial Design

12 Treatment Groups

Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)
1 of 12
Part 1: Sequential escalation (Completed)
1 of 12
Part 1a: Dose Escalation, Combination, Breast
1 of 12
Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1
1 of 12
Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)
1 of 12
Part 1b Dose Escalation, Combination, Breast
1 of 12
Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)
1 of 12
Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)
1 of 12
Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)
1 of 12
Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)
1 of 12
Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)
1 of 12
sequential escalation
1 of 12

Experimental Treatment

228 Total Participants · 12 Treatment Groups

Primary Treatment: eFT226 · No Placebo Group · Phase 1 & 2

Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)Experimental Group · 2 Interventions: Abemaciclib, Fulvestrant · Intervention Types: Drug, Drug
Part 1: Sequential escalation (Completed)
Drug
Experimental Group · 1 Intervention: eFT226 · Intervention Types: Drug
Part 1a: Dose Escalation, Combination, Breast
Drug
Experimental Group · 1 Intervention: Fulvestrant · Intervention Types: Drug
Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1
Drug
Experimental Group · 1 Intervention: Fulvestrant · Intervention Types: Drug
Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)
Drug
Experimental Group · 1 Intervention: eFT226 · Intervention Types: Drug
Part 1b Dose Escalation, Combination, Breast
Drug
Experimental Group · 1 Intervention: Fulvestrant · Intervention Types: Drug
Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)
Drug
Experimental Group · 1 Intervention: Fulvestrant · Intervention Types: Drug
Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)
Drug
Experimental Group · 1 Intervention: Sotorasib · Intervention Types: Drug
Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)
Drug
Experimental Group · 1 Intervention: eFT226 · Intervention Types: Drug
Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)
Drug
Experimental Group · 1 Intervention: Trastuzumab · Intervention Types: Drug
Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)
Drug
Experimental Group · 1 Intervention: eFT226 · Intervention Types: Drug
sequential escalation
Drug
Experimental Group · 1 Intervention: eFT226 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1890
Sotorasib
2022
Completed Phase 1
~340
Trastuzumab
2014
Completed Phase 4
~9050
Fulvestrant
2011
Completed Phase 3
~3810

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from start of study therapy to the first documentation of disease progression or death from any cause, which ever came first, assessed up to 100 months

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
Robert Sikorski, MD, PhDStudy DirectorEffector Therapeutics
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received endocrine therapy in the advanced/metastatic disease setting.
Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting, which may include combination therapy (eg, with a CDK4/6 inhibitor).
You have received one or more lines of therapy for advanced/metastatic disease.
You have a maximum of five prior lines of therapy for advanced/metastatic disease.
Patient has undergone treatment with platinum-based chemotherapy and an anti-PD-1/L1 agent, if appropriate.
Patients with KRAS G12C mutations are excluded.