Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies
Lead Sponsor:
Treadwell Therapeutics, Inc
Collaborating Sponsors:
TIO Discovery Engine
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed 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 com...
Eligibility Criteria
Inclusion
- Key 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
- 1\. 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.
- Key
Exclusion
- 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).
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04521413
Start Date
August 31 2020
End Date
December 1 2025
Last Update
May 21 2025
Active Locations (13)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
The Angeles Clinic
Los Angeles, California, United States, 90025
3
Yale Cancer Center
New Haven, Connecticut, United States, 06519
4
Florida Cancer Specialists
Sarasota, Florida, United States, 34232