What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as kinase inhibitors and PD-1 inhibitors like pembrolizumab, have distinct side effect profiles. Kinase inhibitors often cause fatigue, diarrhea, hypertension, and hand-foot syndrome. PD-1 inhibitors can lead to immune-related adverse effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. These side effects result from the enhanced immune response against tumors, which can also affect normal tissues.

What prior FDA approvals exist?

The FDA has approved several kinase inhibitors and PD-1 inhibitors for the treatment of solid tumors. Pembrolizumab, a PD-1 inhibitor, has been approved for various cancers, including non-small cell lung cancer (NSCLC), melanoma, and esophageal cancer, among others. Other PD-1 inhibitors like Nivolumab have also received approval for similar indications. Kinase inhibitors, such as Erlotinib and Gefitinib, have been approved for NSCLC with specific genetic mutations. These treatments enhance the immune response against tumors or target specific pathways critical for cancer cell survival and proliferation.

What other types of research exist?

Promising alternatives to CFI-402411 and Pembrolizumab for solid tumor patients include: 1) Nivolumab (PD-1 inhibitor) - shown efficacy in various solid tumors including NSCLC and melanoma. 2) Atezolizumab (PD-L1 inhibitor) - effective in NSCLC and other solid tumors. 3) Lorlatinib (ALK inhibitor) - effective in ALK-positive NSCLC with brain metastases. 4) Alectinib (ALK inhibitor) - effective in ALK-rearranged NSCLC. 5) Osimertinib (EGFR inhibitor) - effective in EGFR-mutated NSCLC, including those with brain metastases.

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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.

Must not have

Previous treatment with an HPK1 inhibitor in other clinical trials.

Known central nervous system metastasis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new pill called CFI-402411, alone and with another drug, pembrolizumab, in patients with advanced cancers that haven't responded to other treatments. The new pill works by blocking a protein that may help the immune system attack the cancer. Combining it with pembrolizumab could make this effect even stronger.

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.

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.

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

Select...

I have been diagnosed with Merkel cell carcinoma.

Select...

My cancer does not respond to current treatments or I cannot tolerate them.

Select...

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.

Select...

I am older than 18 years.

Select...

My advanced cancer does not respond to standard treatments.

Select...

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.

Select...

I am eligible for pembrolizumab and have one of the listed advanced cancers that is not responding to standard treatments.

Select...

I have cancer in my stomach or esophagus.

Select...

My cancer has worsened after 1 to 3 treatments for its spread.

Select...

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.

Select...

My cancer type is confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have never been treated with an HPK1 inhibitor in any clinical trial.

Select...

My cancer has spread to my brain.

Select...

I have an autoimmune disease or significant autoimmune disorder.

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I have not had a stroke, mini-stroke, or blood clot in the last 3 months.

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I have heart issues like heart failure, chest pain, or a recent heart attack.

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I have long-term irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3130

0 / 27Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Kinase inhibitors and PD-1 inhibitors are common treatments for solid tumors. Kinase inhibitors block specific enzymes involved in cell signaling pathways that regulate tumor growth and survival, thereby reducing tumor proliferation. PD-1 inhibitors, like pembrolizumab, enhance the immune system's ability to attack tumor cells by preventing tumors from evading immune detection. These targeted therapies are important for solid tumor patients as they offer more effective and personalized treatment options with potentially fewer side effects compared to traditional chemotherapy.

Current and Future Therapies for Advanced Gastric Cancer.