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CFI-402411 + Pembrolizumab for Solid Cancer

Phase 1 & 2
Recruiting
Led By Johanna Bendell, Dr
Research Sponsored by Treadwell Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Merkel cell carcinoma
Tumors must be refractory to or subjects intolerant of current standard treatment(s) and for whom no standard therapies are available.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial is testing an investigational drug called CFI-402411 as a possible treatment for advanced solid tumors.

Who is the study for?
Adults over 18 with advanced solid tumors that have worsened after at least one but no more than three systemic therapies. Eligible cancers include NSCLC, SCLC, urothelial, renal cell carcinoma, triple negative breast cancer, endometrial cancer regardless of MSI status, cervical cancer, gastroesophageal cancer, hepatocellular cancer or any tumor known to be MSI-H. Patients must have measurable disease and be in good physical condition (ECOG 0-1). They should not respond to standard treatments or tolerate them.Check my eligibility
What is being tested?
The trial is testing CFI-402411's safety and effectiveness alone and combined with pembrolizumab for patients with advanced solid tumors who've had previous treatment failures. The study will assess how well these drugs work together and what side effects they may cause.See study design
What are the potential side effects?
Potential side effects from CFI-402411 and pembrolizumab could include immune-related reactions affecting various organs; infusion-related symptoms like fever or chills; fatigue; digestive issues such as nausea or diarrhea; blood abnormalities leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Merkel cell carcinoma.
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My cancer does not respond to current treatments or I cannot tolerate them.
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My kidney cancer is either clear cell or non-clear cell type.
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I am fully active or can carry out light work.
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I am older than 18 years.
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My advanced cancer does not respond to standard treatments.
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I have cervical cancer.
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I am eligible for pembrolizumab and have one of the listed advanced cancers that is not responding to standard treatments.
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I am eligible for pembrolizumab and have one of the listed advanced cancers that is not responding to standard treatments.
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I have cancer in my stomach or esophagus.
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My cancer has worsened after 1 to 3 treatments for its spread.
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My cancer does not respond to standard treatments, or I cannot tolerate them.
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My breast cancer is triple negative.
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I have liver cancer.
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My cancer is identified as high in microsatellite instability.
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My advanced cancer does not respond to standard treatments.
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My cancer is squamous cell carcinoma in the head, neck, anal canal, or skin.
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My cancer does not respond to standard treatments or I cannot receive them.
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I have endometrial cancer.
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I have an advanced cancer type listed and it's not responding to standard treatments.
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My cancer type is confirmed by lab tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the incidence of adverse events of CFI-402411 as a single agent and at the recommended phase 2 dose (RP2D).
To assess the incidence of adverse events with CFI-402411 in combination with pembrolizumab and at the RP2D.
To examine best overall response rate in subjects treated at multiple dose levels of CFI-402411.
+1 more
Secondary outcome measures
To assess best overall response of CFI-402411 monotherapy and in combination with pembrolizumab.
To assess duration of response of CFI-402411 monotherapy and in combination with pembrolizumab.
To assess overall response rates of CFI-402411 monotherapy and in combination with pembrolizumab.
+10 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

5Treatment groups
Experimental Treatment
Group I: B2: Combination ExpansionExperimental Treatment2 Interventions
Dose expansion arm with the recommended phase 2 dose of CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).
Group II: B1: Combination EscalationExperimental Treatment2 Interventions
Dose escalation arm with CFI-402411 in combination with pembrolizumab (at its labeled dose and schedule).
Group III: A3: Monotherapy ExpansionExperimental Treatment1 Intervention
Dose expansion arm with CFI-402411 at its recommended phase 2 dose.
Group IV: A2: Monotherapy BiomarkerExperimental Treatment1 Intervention
Dose escalation biomarker arm with CFI-402411. CFI-402411 is administered orally once daily.
Group V: A1: Monotherapy EscalationExperimental Treatment1 Intervention
Dose escalation arm with CFI-402411. CFI-402411 is administered orally once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Treadwell Therapeutics, IncLead Sponsor
3 Previous Clinical Trials
133 Total Patients Enrolled
TIO Discovery EngineUNKNOWN
Johanna Bendell, DrPrincipal InvestigatorSarah Cannon

Media Library

CFI-402411 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04521413 — Phase 1 & 2
Solid Tumors Research Study Groups: B1: Combination Escalation, A1: Monotherapy Escalation, A3: Monotherapy Expansion, A2: Monotherapy Biomarker, B2: Combination Expansion
Solid Tumors Clinical Trial 2023: CFI-402411 Highlights & Side Effects. Trial Name: NCT04521413 — Phase 1 & 2
CFI-402411 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04521413 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which ailments is CFI-402411 typically prescribed?

"CFI-402411 is a well established treatment for malignant neoplasms and may also be beneficial in cases of unresectable melanoma, microsatellite instability high, or disease progression following chemotherapy."

Answered by AI

How many medical centers are hosting this scientific inquiry?

"This clinical trial has 12 recruiting sites, including University of California San Diego in La Jolla, Yale Cancer Center in New Haven, and START - San Antonio in San Antonio. Additionally there are another 9 locations that are enrolling patients for the study."

Answered by AI

Are there any prior studies that have utilized CFI-402411 in their investigation?

"Researching CFI-402411, 961 trials are active. Of those studies, 122 of them have progressed to the third phase. Although Houston is a major hub for these trial locations, there are an additional 35727 sites across the world running experiments with this medication."

Answered by AI

What is the current participant count for this experiment?

"To complete this clinical trial, 170 individuals must be recruited who meet the predetermined criteria. Recruitment is being conducted at various sites such as University of California San Diego in La Jolla, California and Yale Cancer Center in New Haven, Connecticut."

Answered by AI

What goals is this research attempting to accomplish?

"This 48-month clinical trial seeks to evaluate the best overall response rate of CFI-402411 at varying doses. Secondary objectives include tracking progression free survival, estimating overall survival rates and studying the pharmacokinetic profile when administered with pembrolizumab via maximum measured plasma concentration (Cmax) analysis."

Answered by AI

Are there still opportunities for individuals to join this clinical trial?

"Affirmative. According to the clinicaltrials.gov data, this medical study is still recruiting participants after its initial listing on August 31st 2020 and subsequent update from July 26th 2022. 170 people must be sourced from 12 different centres for inclusion in the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies
2020. "Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521413.
~20 spots leftby Nov 2024
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