CFI-402411 for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Solid TumorsCFI-402411 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 13 Secondary · Reporting Duration: 48 months

48 months
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.
To assess overall survival of CFI-402411 monotherapy and in combination with pembrolizumab.
To assess progression free survival of CFI-402411 monotherapy and in combination with pembrolizumab.
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 assess the pharmacokinetic profile of CFI-402411 alone when it is administered in combination with pembrolizumab though Cmin.
To assess the pharmacokinetic profile of CFI-402411 alone when it is administered in combination with pembrolizumab through AUC.
To assess the pharmacokinetic profile of CFI-402411 alone when it is administered in combination with pembrolizumab through Cmax.
To assess the pharmacokinetic profile of CFI-402411 alone when it is administered in combination with pembrolizumab through T1/2.
To assess the pharmacokinetic profile of CFI-402411 alone when it is administered in combination with pembrolizumab through Tmax.
To evaluate the effect of CFI-402411 treatment on immune- or disease related biomarkers.
To examine best overall response rate in subjects treated at multiple dose levels of CFI-402411.
To examine progression free survival in subjects treated at multiple dose levels of CFI-402411.
To further assess the incidence of adverse events of CFI-402411.
To identify the maximum tolerated dose of single agent CFI-402411 alone and in combination with pembrolizumab.

Trial Safety

Safety Progress

1 of 3

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

5 Treatment Groups

B1: Combination Escalation
1 of 5
A1: Monotherapy Escalation
1 of 5
A3: Monotherapy Expansion
1 of 5
A2: Monotherapy Biomarker
1 of 5
B2: Combination Expansion
1 of 5

Experimental Treatment

170 Total Participants · 5 Treatment Groups

Primary Treatment: CFI-402411 · No Placebo Group · Phase 1 & 2

B1: Combination EscalationExperimental Group · 2 Interventions: CFI-402411, Pembrolizumab · Intervention Types: Drug, Drug
A1: Monotherapy Escalation
Drug
Experimental Group · 1 Intervention: CFI-402411 · Intervention Types: Drug
A3: Monotherapy Expansion
Drug
Experimental Group · 1 Intervention: CFI-402411 · Intervention Types: Drug
A2: Monotherapy Biomarker
Drug
Experimental Group · 1 Intervention: CFI-402411 · Intervention Types: Drug
B2: Combination ExpansionExperimental Group · 2 Interventions: CFI-402411, Pembrolizumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 months

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
Omid Hamid, DrPrincipal InvestigatorThe Angeles Clinic, Los Angeles

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received at least one systemic therapy for recurrent / metastatic disease.
You have a performance status of 0 or 1.
The patient must be receiving monotherapy with an antiretroviral drug.
You have a histological or cytological diagnosis 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.