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NCT04092673 | RECRUITING | Solid Tumor, Adult

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
Sponsor:

Effector Therapeutics

Brief Summary:

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor malignancies.

Condition or disease

Solid Tumor, Adult

Intervention/treatment

eFT226

Sotorasib

Fulvestrant

Abemaciclib

Trastuzumab

Phase

PHASE1

PHASE2

Detailed Description:

Part 1 (Dose Escalation): Completed; Recommended Phase 2 Dose (RP2D) and Maximum Tolerated Dose (MTD) identified Part 1a (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy. Part 1b (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy. Part 2 (Expansion Cohort) provides defined expansion cohorts to further explore the safety, pharmacology, and clinical activity of eFT226 monotherapy and in various combinations in subjects with previously treated advanced solid tumor malignancies.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous Zotatifin (eFT226) in Subjects With Selected Advanced Solid Tumor Malignancies
Actual Study Start Date : 2019-10-25
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Criteria
  • Parts 1a and 1b (Dose Escalation + Fulvestrant)
    • * Patient has histological or cytological confirmation of breast cancer.
    • * Patient has metastatic disease or locoregionally recurrent disease which is refractory or intolerant to existing therapy(ies) known to provide clinical benefit.
    • * Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows
      • * Minimum of one prior line of therapy for advanced/metastatic disease.
      • * Maximum of five prior lines of therapy for advanced/metastatic disease.
      • * Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
      • * Prior treatment has included a CDK4/6 inhibitor.
      • * Tumor is ER+ (defined as ER IHC staining \> 0%).
      • Cohort EMNK
        • * Patient has undergone treatment with platinum-based chemotherapy and an anti-PD-1/L1 agent, if appropriate.
        • * Tumor has a known KRAS-activating mutation; Patients with KRAS G12C mutations are excluded.
        • Cohort EMBF
          • * Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows
            • * Minimum of one prior line of therapy for advanced/metastatic disease.
            • * Maximum of five prior lines of therapy for advanced/metastatic disease.
            • * 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).
            • * Tumor is ER+ (defined as ER IHC staining \> 0%) and has FGFR amplification.
            • Cohort EMBH
              • * Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows
                • * Minimum of one prior line of therapy for advanced/metastatic disease.
                • * Minimum of one line of HER2-directed therapy Note: Prior treatment with CDK4/6 inhibitors is permitted.
                • * Tumor is ER+ (defined as ER IHC staining \> 0%) and HER2+ (defined as HER2 3+ IHC staining or HER2 2+ and FISH+).
                • Cohort ECNS
                  • * Patient has histologically or cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC.
                  • * Patient has undergone treatment with platinum-based chemotherapy and an anti-PD-1/L1 agent, if appropriate. Note: Patients who have declined approved therapy(ies) or who per treating physician are not eligible for approved therapy(ies) (eg, due to intolerance) may be eligible following discussion with the Medical Monitor.
                  • * Tumor has a known G12C KRAS-activating mutation. Note: Patients who have been previously treated with KRAS-specific therapy are excluded.
                  • Cohort ECBF
                    • * Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows
                      • * Minimum of one prior line of therapy for advanced/metastatic disease.
                      • * Maximum of five prior lines of therapy for advanced/metastatic disease.
                      • * Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
                      • * Prior treatment has included a CDK4/6 inhibitor.
                      • * Tumor is ER+ (defined as ER IHC staining \> 0%).
                      • Cohort ECBF+A
                        • * Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows
                          • * Minimum of one prior line of therapy for advanced/metastatic disease.
                          • * Maximum of five prior lines of therapy for advanced/metastatic disease.
                          • * Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
                          • * Tumor is ER+ (defined as ER IHC staining \> 0%) and HER2- (defined as absence of HER2 3+ IHC staining and/or absence of FISH+).
                          • Cohort ECBT
                            • * Patient has progressed after treatment with at least one approved anti-HER2 agent and has been administered at least one line of chemotherapy.
                            • * Tumor is HER2+ (defined as HER2 3+ IHC staining or HER2 2+ and FISH+). Cohorts EMBF, EMBH, ECBF, ECBF+A: There is no limit on the number of lines of prior endocrine therapies.
                            • Cohort ECBF-D1
                              • * Patient has metastatic disease or locoregionally recurrent disease which is refractory or intolerant to existing therapy(ies) known to provide clinical benefit.
                              • * Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows
                                • * Minimum of one prior line of therapy for advanced/metastatic disease.
                                • * Maximum of five prior lines of therapy for advanced/metastatic disease.
                                • * Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
                                • * Prior treatment has included a CDK4/6 inhibitor.
                                • * Tumor is ER+ (defined as ER IHC staining \> 0%).
                                • * Tumor has amplification of Cyclin D1 as determined by next generation sequencing or in situ hybridization.
Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Location Details

NCT04092673

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of Southern California

Los Angeles, California, United States, 90033

RECRUITING

United States, California

Valkyrie Clinical Trials

Los Angeles, California, United States, 90067

COMPLETED

United States, California

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94304

RECRUITING

United States, Road cancer

START Midwest

Grand Rapids, Road cancer, United States, 49546

COMPLETED

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Cancer Center- Monmouth

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center- Commack

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center- Westchester

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care

New York, New York, United States, 11101

COMPLETED

United States, Ohio

University of Toledo Medical Center

Toledo, Ohio, United States, 43614

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

COMPLETED

United States, Texas

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, United States, 78229

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031