This interventional study will evaluate the efficacy and safety of ART0380 as monotherapy in patients whose tumors have a biology to predict for sensitivity to inhibition of Ataxia-Telangiectasia Mutated and Rad3-related protein kinase (ATR).
ART0380 is being developed as an oral anti-cancer agent for the treatment of patients with cancers that have defects in deoxyribonucleic acid (DNA) repair. The study will recruit selected patients with advanced or metastatic solid tumors, specifically: * Patients with persistent or recurrent endometrial cancer (EC) * Patients with advanced or metastatic solid tumors of any histology Above patients will be randomized in a 1:1 ratio to one of two dose regimens of ART0380. Safety will be evaluated on a quarterly basis, at a minimum. Patients may continue to receive ART0380 as long as they are continuing to derive benefit from treatment or until disease progression, withdrawal of consent, or until they experience unacceptable drug-related toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Randomized patients will orally receive ART0380.
University of California Los Angeles (UCLA)
Los Angeles, California, United States
The University of Chicago
Chicago, Illinois, United States
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients with a complete response (CR) or partial response (PR) to treatment according to Response evaluation criteria in solid tumors (RECIST v1.1).
Time frame: Until disease progression (Every 6 weeks from randomization Upto 2 Years)
Number of patients with adverse events
To assess the safety and tolerability of ART0380 in patients with solid tumors.
Time frame: From Cycle 1 (each Cycle is 21-day) Day 1 until 30-day follow-up visit (Upto 2 Years)
Progression free survival (PFS)
The PFS is defined as the time from randomization until the earliest objective disease progression defined by RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG-3) (for patients with prostate cancer in Arm 2) or death by any cause in the absence of progression, regardless of whether the patient withdraws from study medication or receives another anti-cancer therapy prior to progression.
Time frame: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)
Best overall response (BOR)
The best overall response is the best response (complete response, and partial response) recorded from the date of randomization for each patient until the progression or censoring date in the absence of progression.
Time frame: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)
Disease control rate (DCR)
To further explore the efficacy of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.
Time frame: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dana Farber Cancer Center
Boston, Massachusetts, United States
Northwell Health R.J. Zuckerberg Cancer Center
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - Oncology
New York, New York, United States
University of Oklahoma/Sarah Cannon Research Institute
Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Institut de Cancérologie de l'Ouest
Angers, NAP, France
Centre Francois Baclesse - Service d'Oncologie médicale
Caen, NAP, France
...and 5 more locations
Duration of response (DOR)
The DOR will be defined for patients with a BOR of CR/PR, as the time from the date of first documented response until date of documented progression (by RECIST v1.1) or death in the absence of disease progression.
Time frame: Screening (≤28 days) Until disease progression or death (Every 6 weeks from randomization Upto 2 Years)
Change in tumor size
The best percentage change in tumor size from baseline will be determined for each patient, ie, the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.
Time frame: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)
Overall survival (OS)
The OS is defined as the time from the randomization until death due to any cause.
Time frame: Screening (≤28 days) Until overall survival follow-up (Every 12 weeks until data cut-off)
Maximum plasma concentration (Cmax)
To determine the Cmax of ART0380 following single oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.
Time frame: Pre-dose Cycle 1 day 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1 Upto 2 Years (Each Cycle is 21-days)
Half life (t1/2)
To determine the t1/2 of ART0380 following single oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.
Time frame: Pre-dose Cycle 1 days 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1 Upto 2 Years (Each Cycle is 21-days)
Area under the plasma concentration-time curve from zero to infinity (AUC0-inf)
To determine the AUC0-inf of ART0380 following single oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.
Time frame: Pre-dose Cycle 1 days 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1 Upto 2 Years (Each Cycle is 21-days)