Status:
RECRUITING
Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
Lead Sponsor:
Effector Therapeutics
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Z...
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 can...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04092673
Start Date
October 25 2019
End Date
March 31 2025
Last Update
May 21 2024
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California
Los Angeles, California, United States, 90033
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
4
Stanford University
Palo Alto, California, United States, 94304