Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Pembrolizumab

Coal Tar

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Dose escalation arm with CFI-402411. CFI-402411 is administered orally once daily.

Dose escalation biomarker arm with CFI-402411. CFI-402411 is administered orally once daily.

Dose expansion arm with CFI-402411 at its recommended phase 2 dose.

Dose escalation arm with CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).

Dose expansion arm with the recommended phase 2 dose of CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).

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.

CFI-402411

Pembrolizumab will be given at its labeled dose and schedule, 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.

Treadwell Therapeutics Clinical Trials

Ceonne Kim

Michele Azada

Ingrid Palmer

Donna Jones

Robinson Katie

Miller Elizabeth

Munir Chowdhury

Isabel Jimenez

Melissa Hackmaster

Carly Mack

Scott Laurie

Ashley Adile

Jane Koh

Omid Hamid, Dr

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.

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.

Dose escalation and expansion for monotherapy and combination arms with pembrolizumab

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

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.

The number of subjects who experience an adverse event that was possibly related to study drug.

Best overall response rate will be summarized by dose cohort and overall using the percent of patients in each tumor response category.

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.

Safety tables and pharmacokinetic tables will be assessed.

For all subjects the overall response rates of complete response and partial response will be calculated and summarized by dose cohort and overall.

The time from first dose until the date of death from any cause will be calculated and summarized for all patients by dose cohort and overall.

The time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first, will be calculated and summarized for all patients by dose cohort and overall.

Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.

Cmax will be assessed through the maximum measured plasma concentration occurring at Tmax tabulated by dose group.

Tmax will be assessed by the time to achieve maximum plasma concentration and will be tabulated by dose group.

Cmin will be calculated through the measured pre-dose plasma concentration and tabulated by dose group.

Elimination half life will be calculated and tabulated by dose group.

The effects of CFI-402411 on pharmacodynamic biomarkers (cytokine levels) will be assessed by percent changes from baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies	NCT04521413	Advanced Solid ...	CFI-402411 Pembrolizumab	18 Years -	Treadwell Therapeutics, Inc
Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies	NCT04521413	Advanced Solid ...	CFI-402411 Pembrolizumab	18 Years -	Treadwell Therapeutics, Inc

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