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Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

NCT04521413•Treadwell Therapeutics, Inc

View on ClinicalTrials.gov

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.

Detailed Description

This study will be a first-in-human study evaluating the safety and tolerability of CFI-402411 in subjects with advanced solid malignancies, when CFI-402411 is administered as a single agent or in combination with pembrolizumab. CFI-402411 is an oral pill that blocks the function of HPK1. Blocking HPK1 could stimulate an immune response against the tumor in patients. This immune response could be further enhanced when combined with pembrolizumab. The data obtained from this study will determine the dose and schedule and subject selection for further clinical studies. Pre-clinical findings support further development of CFI-402411 as a novel anti-cancer agent, and the combination of CFI-402411 with pembrolizumab as a potential strategy to improve outcomes of subjects with advanced malignancies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \> 18 years old
•2. Have progressed after ≥ 1, but no more than 3 regimens of systemic therapies for recurrent / metastatic disease.
•3. Subjects must have measurable disease.
•4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•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.
•1. Histological or cytological confirmation of one of the advanced cancers listed below;
•* NSCLC
•* SCLC
•* cutaneous melanoma
•* Merkel cell carcinoma
+57 more criteria

Exclusion Criteria

•Subjects will be excluded from the study if any of the following criteria is met;
•1. Previous treatment with an HPK1 inhibitor in other clinical trials.
•2. Diagnosis of autoimmune-based disease or clinically significant auto-immune disorders.
•3. Have symptomatic congestive heart failure, active angina pectoris or recent myocardial infarction (within 6 mos).
•4. Have chronic atrial fibrillation.
•5. Known central nervous system metastasis.
•6. Stroke or transient ischemic attack, or other ischemic events or thromboembolic events within 3 months of study enrollment.
•7. 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).

Locations (13)

University of California San Diego

La Jolla, California, United States

The Angeles Clinic

Los Angeles, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists

Sarasota, Florida, United States

START - Mid-West

Grand Rapids, Michigan, United States

SCRI - Nashville

Nashville, Tennessee, United States

MD Anderson

Houston, Texas, United States

START - San Antonio

San Antonio, Texas, United States

Virginia Cancer Specialist

Fairfax, Virginia, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

Key Dates

Start Date

August 31, 2020

Primary Completion Date

November 1, 2025

Completion Date

December 1, 2025

Last Updated

May 21, 2025

Enrollment

170

ESTIMATED participants

Conditions

Advanced Solid Malignancies

Interventions

CFI-402411

DRUG

Pembrolizumab

DRUG

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

NCT06760481

Advanced Solid Malignancies

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COMPLETEDPHASE1

Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

NCT05573724

Advanced Solid Malignancies

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WITHDRAWNPHASE1

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Inclusion Criteria

Exclusion Criteria

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies

A Phase I Dose Escalation Study of Erlotinib in Combination With Theophylline