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ART0380 in Advanced or Metastatic Solid Tumors
NCT04657068Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2021
- Primary completion
- Jan 2028
- Countries
- 4
- Sponsor
- Artios Pharma
- Modality
- Small Molecules
- Drugs
- alnodesertib
- Conditions
- cancermetastatic cancerovarian cancerprimary peritoneal cancer (PPC)fallopian tube cancer (PFTC)
01
Overview
Phase 2, randomised, open-label trial of alnodesertib in cancer, metastatic cancer, ovarian cancer and 6 more (10 arms), sponsored by Artios Pharma. Primary endpoints: Maximum Tolerated Dose at 21 days, Adverse Events and 2 more. Started Jan 2021; status: recruiting.
02
Design
10 arms- Study design
- RandomizedOpen-label
Part A1
ART0380 monotherapy
Part A2
ART0380 + Gemcitabine
Part A3
ART0380 + Irinotecan
Part B1
ART0380 monotherapy OR ART0380 + Irinotecan
Part B2
ART0380 + Gemcitabine OR Gemcitabine alone
Part B3
ART0380 monotherapy
4 more in the full profile.
03
Who it enrols
Patients with advanced or metastatic solid tumors, including specific cohorts for ovarian, endometrial, colorectal, and pancreatic cancers, with acceptable organ function and ECOG PS 0-1. Specific cohorts require ATM or BRCA mutations/HRD positivity. Excludes patients with severe cardiovascular disease, active brain metastases, or specific UGT1A1 genotypes for irinotecan cohorts.
04
Endpoints
Primary
Maximum Tolerated Dose
Adverse Events
Progression-Free Survival
Objective Response Rate
Secondary
Pharmacokinetic Parameters
Serological Tumor Markers
Duration of Response
Overall Survival
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