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

  • STATUS
    Recruiting
  • End date
    Jun 14, 2024
  • participants needed
    170
  • sponsor
    Treadwell Therapeutics, Inc
Updated on 14 April 2021

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.

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.

Details
Condition Advanced Solid Malignancies
Treatment Pembrolizumab, CFI-402411
Clinical Study IdentifierNCT04521413
SponsorTreadwell Therapeutics, Inc
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Study-Wide Eligibility (Across All Study Parts)
Age > 18 years old
Have progressed after 1, but no more than 3 regimens of systemic therapies for recurrent / metastatic disease
Subjects must have measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Part A1: Monotherapy Dose Escalation Inclusion Criteria
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
Part A2: Biomarker-Focused Monotherapy Backfills Inclusion Criteria
Histological or cytological confirmation of one of the advanced cancers listed below
NSCLC
SCLC
cutaneous melanoma
Merkel cell carcinoma
squamous cell carcinoma of head and neck, anal canal, or skin
urothelial cancer
clear cell or non-clear cell renal cell carcinoma
triple negative breast cancer
endometrial cancer (regardless of MSI status)
cervical cancer
gastroesophageal cancer
hepatocellular cancer
any histology if known to be microsatellite-instability high (MSI-H)
Tumors must be refractory to or not a candidate for current standard treatment(s) and for whom no standard therapy exists
Part A3: Monotherapy Expansion Inclusion Criteria
Histological or cytological confirmation of one of the advanced cancers listed below
NSCLC cancer any histology
SCLC
cutaneous melanoma
Merkel cell carcinoma
squamous cell carcinoma of head and neck, anal canal, or skin
urothelial cancer
clear cell or non-clear cell renal cell carcinoma
triple negative breast cancer
endometrial cancer (regardless of MSI status)
cervical cancer
gastroesophageal cancer
hepatocellular
any histology if known to be microsatellite-instability high (MSI-H)
Tumors must be refractory to or subjects intolerant of current standard treatment(s) and for whom no standard therapies are available
Optional biopsies: Subjects that consent to optional fresh tumor biopsies must have at least one non-target soft tissue tumor lesion that can be biopsied
Part B1: CFI-402411 in Combination with Pembrolizumab Dose Escalation
Inclusion Criteria
Subjects must be deemed eligible by the Investigator to receive pembrolizumab
Histological or cytological confirmation of one of the advanced cancers listed below (list may vary in each country, USA shown here)
NSCLC cancer any histology
SCLC
cutaneous melanoma
Merkel cell carcinoma
squamous cell carcinoma of head and neck, anal canal, or skin
urothelial cancer
clear cell or non-clear cell renal cell carcinoma
triple negative breast cancer
endometrial cancer (regardless of MSI status)
cervical cancer
gastroesophageal cancer
hepatocellular cancer
any histology if known to be microsatellite-instability high (MSI-H)
Tumors must be refractory to or subjects intolerant of current standard
treatment(s) or for whom no standard therapy is available
Part B2: CFI-402411 in Combination with Pembrolizumab Expansion Inclusion
Criteria
Subjects must be deemed eligible by the Investigator to receive pembrolizumab
Histological or cytological confirmation of one of the advanced cancers listed below (list may vary in each country, USA shown here)
non-small cell lung cancer any histology
SCLC
cutaneous melanoma
Merkel Cell carcinoma
squamous cell carcinoma of head and neck, anal canal, or skin
urothelial cancer
clear cell or non-clear cell renal cell carcinoma
triple negative breast cancer
endometrial cancer (regardless of MSI status)
gastroesophageal cancer
hepatocellular cancer
any histology if known to be microsatellite-instability high (MSI-H)
Tumors must be refractory to or subjects intolerant of current standard non-IO treatment(s) or for whom no standard therapy is available

Exclusion Criteria

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