At a glance
ClinicalIndex Comparison RecordPhase 1Recruiting· 345 target
Drug / intervention
NX-1607 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 10
- ✓Age 18 years or older
- ✓Measurable disease per disease-specific response criteria
- ✓Metastatic or unresectable disease; previously treated, not candidate for, or unable to receive standard treatment
- ✓ECOG performance status 0 or 1
Key exclusion· 20
- ✕Active untreated brain metastases
- ✕Uncontrolled intercurrent illness including poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy
- ✕Primary refractory EOC (no response to first platinum regimen or relapse <6 months after completion)
- ✕Psychiatric illness limiting compliance with study requirements
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types
In Brief
A Phase 1 clinical trial evaluating NX-1607 and Paclitaxel for Ovarian Cancer, Epithelial and 13 related conditions. Currently recruiting, targeting 345 participants across 17 sites in 2 countries.
Signals
Enrolling ahead of pace
Detailed Summary
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Epithelial, Gastric Cancer, GastroEsophageal Junction (GEJ) Cancer, Head and Neck Squamous Cell Carcinoma, Metastatic or Unresectable Melanoma, Non-small Cell Lung Cancer (NSCLC), Metastatic Castration-resistant Prostate Cancer (mCRPC), Malignant Pleural Mesothelioma (MPM), Triple Negative Breast Cancer (TNBC), Metastatic Urothelial Carcinoma, Cervical Cancer, Diffuse Large B Cell Lymphoma (DLBCL), Richter Transformation, Microsatellite Stable Colorectal Carcinoma
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 1Recruiting
2022202320242025202620272028
Enrollment StartSep 2021
First PostedNov 2021
TodayJul 2026
Primary CompletionAug 2026
Study CompletionFeb 2028
First PostedNov 4, 2021
Enrollment StartSep 29, 2021
Primary CompletionAug 31, 2026
Study CompletionFeb 28, 2028
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 4.7 years agoPrimary completion in 2 months
Interventions
NX-1607drug
Oral NX-1607
Paclitaxeldrug
Paclitaxel IV