Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies
A First-In-Human, Phase 1/2 Study Of CFI-402411, a Hematopoietic Progenitor Kinase-1 (HPK1) Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies
1 other identifier
interventional
170
3 countries
13
Brief Summary
The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 21, 2025
September 1, 2024
5.2 years
July 31, 2020
May 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To assess the incidence of adverse events of CFI-402411 as a single agent and at the recommended phase 2 dose (RP2D).
The number of subjects who experience an adverse event that was possibly related to study drug.
48 months
To assess the incidence of adverse events with CFI-402411 in combination with pembrolizumab and at the RP2D.
The number of subjects who experience an adverse event that was possibly related to study drug.
48 months
To examine best overall response rate in subjects treated at multiple dose levels of CFI-402411.
Best overall response rate will be summarized by dose cohort and overall using the percent of patients in each tumor response category.
48 months
To examine progression free survival in subjects treated at multiple dose levels of CFI-402411.
Time from first dose to disease progression or death whichever occurs first will be calculated and summarized for all patients by dose cohort and overall.
48 months
Secondary Outcomes (13)
To identify the maximum tolerated dose of single agent CFI-402411 alone and in combination with pembrolizumab.
48 months
To further assess the incidence of adverse events of CFI-402411.
48 months
To assess best overall response of CFI-402411 monotherapy and in combination with pembrolizumab.
48 months
To assess overall response rates of CFI-402411 monotherapy and in combination with pembrolizumab.
48 months
To assess overall survival of CFI-402411 monotherapy and in combination with pembrolizumab.
48 months
- +8 more secondary outcomes
Study Arms (5)
A1: Monotherapy Escalation
EXPERIMENTALDose escalation arm with CFI-402411. CFI-402411 is administered orally once daily.
A2: Monotherapy Biomarker
EXPERIMENTALDose escalation biomarker arm with CFI-402411. CFI-402411 is administered orally once daily.
A3: Monotherapy Expansion
EXPERIMENTALDose expansion arm with CFI-402411 at its recommended phase 2 dose.
B1: Combination Escalation
EXPERIMENTALDose escalation arm with CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).
B2: Combination Expansion
EXPERIMENTALDose expansion arm with the recommended phase 2 dose of CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).
Interventions
CFI-402411 is administered orally once daily. The starting dose is 80 mg/day for escalation arms and the recommended dose for the expansion arms.
Pembrolizumab will be given at its labeled dose and schedule, 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- Have progressed after ≥ 1, but no more than 3 regimens of systemic therapies for recurrent / metastatic disease.
- Subjects must have measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- \. Histological or cytological confirmation of advanced solid malignancy that is refractory to or not a candidate for current standard treatment(s) and for whom no standard therapy is available.
- Histological or cytological confirmation of one of the advanced cancers listed below;
- NSCLC
- SCLC
- cutaneous melanoma
- Merkel cell carcinoma
- squamous cell carcinoma of head and neck, anal canal, or skin
- urothelial cancer
- clear cell or non-clear cell renal cell carcinoma
- triple negative breast cancer
- endometrial cancer (regardless of MSI status)
- +52 more criteria
You may not qualify if:
- Subjects will be excluded from the study if any of the following criteria is met;
- Previous treatment with an HPK1 inhibitor in other clinical trials.
- Diagnosis of autoimmune-based disease or clinically significant auto-immune disorders.
- Have symptomatic congestive heart failure, active angina pectoris or recent myocardial infarction (within 6 mos).
- Have chronic atrial fibrillation.
- Known central nervous system metastasis.
- Stroke or transient ischemic attack, or other ischemic events or thromboembolic events within 3 months of study enrollment.
- A history of QTc prolongation or a marked baseline prolongation of QT/QTc interval or a history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Treadwell Therapeutics, Inclead
- TIO Discovery Enginecollaborator
Study Sites (13)
University of California San Diego
La Jolla, California, 92093, United States
The Angeles Clinic
Los Angeles, California, 90025, United States
Yale Cancer Center
New Haven, Connecticut, 06519, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
START - Mid-West
Grand Rapids, Michigan, 49546, United States
SCRI - Nashville
Nashville, Tennessee, 37023, United States
MD Anderson
Houston, Texas, 77030, United States
START - San Antonio
San Antonio, Texas, 78229, United States
Virginia Cancer Specialist
Fairfax, Virginia, 22031, United States
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
Prince of Wales Hospital
Shatin, Hong Kong
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Omid Hamid, Dr
The Angeles Clinic, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 20, 2020
Study Start
August 31, 2020
Primary Completion
November 1, 2025
Study Completion
December 1, 2025
Last Updated
May 21, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share
It is too early to determine whether we will make IPD available - we do not yet have a process written on this. Field will be updated once our policy / process is written.