Advanced CancerPhase 1/2NCT04657068
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing ART0380, Gemcitabine and Irinotecan in people with Advanced Cancer and Metastatic Cancer, run by Artios Pharma Ltd at 88 sites in 4 countries.
Trial summary
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan Learn more about the side effects… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer, Ovarian Cancer
- What is being tested?
- ART0380, Gemcitabine and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 88 sitesin 4 countries
- Study dates
- 27 Jan 2021to Jun 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent or recurrent endometrial cancer with biological selection.:
- Patients should have received taxane/platinum chemotherapy, unless contraindicated.
- Measurable disease.
- Advanced or metastatic solid cancers of any histology with biological selection
- If a PD-1/PDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.
- Radiologically evaluable disease
Show all 44Show fewer
- Performance status of 0-1 on the ECOG scale
- Metastatic CRC with alterations to the ATM gene
- Participants should have previously received appropriate prior lines of therapy in this setting.
- Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1.
- Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC.
- Serum albumin ≥3g/dL within 7 days prior to first dose.
- ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.
- Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease
- Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene
- Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant/adjuvant therapy with recurring occurring <6 months following completion of this treatment.
- Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions.
- Serum albumin ≥3g/dL within 7 days prior to first dose.
- ECOG Performance Status must be stable for at least 2 weeks prior to enrollment.
- Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease.
- General Exclusion Criteria:
- Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment
- Men who plan to father a child while in the study or within5 months after the last administration of study treatment
- Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV/AIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission
- Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
- Moderate or severe cardiovascular disease
- Valvulopathy that is severe, moderate, or deemed clinically significant
- Documented major electrocardiogram (ECG) abnormalities which are clinically significant
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
- Received a live vaccine within 30 days before the first dose of study treatment
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate
- Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study
- Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment.
- A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment
- Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Additional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan):
- Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening.
- Patients who are known to be homozygous for both UGT1A1 *6 and *28 (UGT1A1 7/7 genotype), or simultaneously heterozygous for both UGT1A1 *6 and *28.
- Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment
- Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded
- Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer
- Parts B5 and B6: Initiation of opioids in the previous 2 weeks.
- Parts B5 and B6: Weight loss >10% in the previous 8 weeks.
- Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.
Who cannot join
None listed.
Trial locations and contacts
88 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
88 sites in 4 countries
United States46 sites, 27 recruiting
- Active, not recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
- Completed
Our Lady of the Lake
Baton Rouge, Louisiana, 70808
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Completed
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404
- Recruiting
Oncology Hematology Care Primary
Cincinnati, Ohio, 45242
- Active, not recruiting
Maryland Oncology Hematology - Primary
Columbia, Maryland, 21044
- Recruiting
Mary Crowley Cancer Research
Dallas, Texas, 75230
- Active, not recruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
- Active, not recruiting
Rocky Mountain Cancer Center
Denver, Colorado, 80218
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
- Recruiting
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
- Completed
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Active, not recruiting
Texas Oncology - Northeast Texas
Flower Mound, Texas, 75028
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33901
- Active, not recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
- Completed
Oncology Consultants
Houston, Texas, 77030
- Recruiting
Community Health Network
Indianapolis, Indiana, 46250
- Recruiting
Mayo Clinic (Florida)
Jacksonville, Florida, 32224
- Active, not recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
- Recruiting
Northwell Health Cancer Institute
Lake Success, New York, 11042
- Completed
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
- Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Minnesota Oncology Hematology
Maple Grove, Minnesota, 55369
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
- Completed
Baptist Cancer Center
Memphis, Tennessee, 38120
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt Medical Center
Nashville, Tennessee, 37232
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
- Recruiting
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
- Completed
Florida Cancer Specialists
Orlando, Florida, 32827
- Recruiting
University of Pennsylvania / Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, 19107
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
Mayo Clinic (Minnesota)
Rochester, Minnesota, 55905
- Active, not recruiting
Utah Cancer Specialists
Salt Lake City, Utah, 84106
- Active, not recruiting
Texas Oncology - San Antonio
San Antonio, Texas, 78240
- Active, not recruiting
Sansum Clinic
Santa Barbara, California, 93105
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
- Active, not recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
Mayo Clinic (Arizona)
Scottsdale, Arizona, 85259
- Recruiting
Fred Hutchinson Cancer Center / University of Washington
Seattle, Washington, 98109
- Recruiting
Washington University
St Louis, Missouri, 63110
- Recruiting
The Sidney Kimmel Comprehensive Cancer Center (Johns Hopkins)
Washington D.C., District of Columbia, 20016
- Active, not recruiting
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Spain31 sites, 25 recruiting
- Recruiting
Hospital Clínico Universitario de Santiago (CHUS)
A Coruña, 00000
- Recruiting
Hospital Teresa Herrera (CHUAC)
A Coruña, 15006
- Recruiting
Institut Català d'Oncologia Badalona - Hospital Germans Trias i Pujol
Badalona, 08916
- Recruiting
Next Oncology Barcelona, IOB
Barcelona, Catalonia, 08023
- Recruiting
Vall d'Hebron Institute of Oncology (VIHO)
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
ICO Hospitalet
Barcelona, 08903
- Recruiting
Hospital Universitario Reina Sofia de Córdoba
Córdoba, 14004
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
- Recruiting
Hospital Universitari Doctor Josep Trueta- ICO de Girona
Girona, 17007
- Completed
Hospital Arnau de Vilanova
Lleida, Catalonia, 25198
- Completed
Hospital Universitario La Paz
Madrid, Madrid, 28046
- Active, not recruiting
Clínica Universidad de Navarra
Madrid, Planta -2, 28027
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
- Active, not recruiting
MD Anderson Cancer Center (Madrid
Madrid, 28033
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
- Recruiting
START Madrid Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
START Madrid (Hospital San Chinarro)
Madrid, 28050
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario De Navarra
Pamplona, 31008
- Recruiting
Next - Hospital Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223
- Recruiting
START Rioja
Rioja, Spain, 26006
- Recruiting
H. Parc Tauli
Sabadell, Barcelona, 08208
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Virgen Macarena
Seville, 41009
- Recruiting
Hospital Virgen del Rocío
Seville, 41013
- Recruiting
Instituto Valenciano de Oncología (IVO)
Valencia, Spain, 00000
- Completed
Incliva Biomedical Research Institute, University of Valencia
Valencia, 46010
- Active, not recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
France7 sites, 7 recruiting
- Recruiting
Institut Bergonie
Bordeau, 33076
- Recruiting
Marseille University Hospital Timone
Marseille, 13005
- Recruiting
Hospital Saint-Antoine
Paris, France, 75012
- Recruiting
Saint-Louis Hospital
Paris, 75010
- Recruiting
Hospital de la Pitié-Salpêtrière
Paris, 75013
- Recruiting
CHU de Poitiers (Poitiers University Hospital)
Poitiers, France, 86021
- Recruiting
Institut Gustave Roussy
Villejuif, Cedex, 94805
United Kingdom4 sites, 3 recruiting
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
- Active, not recruiting
Guy's and St Thomas' NHS Foundation Trust
London, London, SE1 9RT
- Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
- Recruiting
The Christie NHS Foundation Trust - The Christie Clinic
Manchester, United Kingdom, M20 4BX
About this study
Official title: A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
- Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan
- Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan
- Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Read the detailed description
ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of Ataxia telangiectasia and Rad3-related (ATR). ART0380 is being developed as an oral anti-cancer agent for the treatment of participants with cancers that harbor defects in deoxyribonucleic acid (DNA) repair and in combination with agents including those that cause DNA damage.
This study is an open-label Phase I/IIa study designed to evaluate the safety, tolerability, PK and preliminary efficacy of ART0380 as monotherapy or in combination with gemcitabine or irinotecan in participants with advanced or metastatic solid tumors, advanced or solid tumors that fail to express Ataxia-Telangiectasia Mutated protein kinase (ATM), and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.
- Conditions
- Advanced Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer
- Being tested
- ART0380, Gemcitabine, Irinotecan
- Keywords
- Loss of Ataxia Telangiectasia Mutated (ATM) protein
- Medical subject headings
- Neoplasm Metastasis, Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Carcinoma, Acinar Cell, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART0380Drug
Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
GemcitabineDrug
Also called Gemzar
Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle.
IrinotecanDrug
Also called Camptosar, Camptothecin-11
Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 | Experimental | Part A1 evaluated intermittent and continuous dosing of ART0380 monotherapy. Treatment was given in 21-day cycles. Receives: Drug: ART0380 |
| Part A2 | Experimental | Part A2 evaluated intermittent dosing of ART0380 in combination with gemcitabine in 21-day cycles. Receives: Drug: ART0380; Drug: Gemcitabine |
| Part A3 | Experimental | Part A3 evaluated intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles. Receives: Drug: ART0380; Drug: Irinotecan |
| Part B1 | Experimental | In Part B1, up to 8 cohorts enrolled participants with solid cancers with alterations in the ATM (ataxia-telangiectasia mutated) gene likely to predict for loss of ATM protein will be treated with either
* ART0380 monotherapy Or
* ART0380 in combination with irinotecan Receives: Drug: ART0380; Drug: Irinotecan |
| Part B2 | Experimental | In Part B2, participants with high grade serous ovarian, primary peritoneal, or fallopian tube carcinoma were randomized (open label) 1:1 to either ART0380 in combination with gemcitabine or gemcitabine alone. Receives: Drug: ART0380; Drug: Gemcitabine |
| Part B3 | Experimental | in Part B3, participants with persistent or recurrent endometrial cancer (EC) received ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle. Receives: Drug: ART0380 |
| Part B4 | Experimental | In Part B4, participants with advanced or metastatic solid tumors received ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle. Receives: Drug: ART0380 |
| Part B5 | Experimental | In Part B5, participants with colorectal cancer (CRC) will receive ART0380 in combination with irinotecan on a 21-day cycle. Receives: Drug: ART0380; Drug: Irinotecan |
| Part B6 | Experimental | In Part B6, participants with pancreatic ductal adenocarcinoma (PDAC) or acinar cell carcinoma will receive ART0380 in combination with irinotecan on a 21-day cycle. Receives: Drug: ART0380; Drug: Irinotecan |
| Part A3 Fed/Fast | Experimental | Part A3 Fed/Fast will evaluate intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles in a fasting or fed state. Receives: Drug: ART0380; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from ART0380 monotherapy and in combination with gemcitabine or irinotecan
Measured: From Cycle 0 Day -2 to Cycle 1 Day 21. Each cycle is 21 days.
Parts B1/B3/B4: Number of participants with adverse events following administration of ART0380 monotherapy and/or in combination with irinotecan at RP2Ds.
Safety reported as incidence of adverse events
Measured: From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380. Each cycle is 21 days.
Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone
Progression free survival (PFS)
Measured: Every 6 weeks from Cycle 1 Day 1 for 18 weeks, then every 9 weeks up to approximately 24 months. Each cycle is 21 days.
Parts B5/B6: Object Response Rate (ORR) based on RECIST 1.1 to access anti-tumor activity of ART0380 in combination with irinotecan in each cohort.
Objective Response Rate (ORR)
Measured: Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each Cycle is 21 days.
Secondary outcomes (33)
Part B2: Number of participants with adverse events following administration of ART0380 in combination with gemcitabine or gemcitabine alone
Measured: From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380 or gemcitabine. Each cycle is 21 days.
Part B5/B6: Number of participants with adverse events following administration of ART0380 at the RP2D in combination with irinotecan.
Measured: From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380 or irinotecan. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): determine the plasma concentration of ART0380 when given alone and in combination
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 4. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): determine the plasma concentration of ART0380 when given alone and in combination
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 4. Each cycle is 21 days.
Pharmacokinetic Analysis (single and multiple dose): Renal clearance of ART0380
Measured: Urine PK will be measured during Cycle 1. Cycle 1 is 21 days.
Pharmacokinetic Analysis (single dose): Maximum plasma Concentration (Cmax) in a fasting and fed state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Time to Maximum plasma concentration (Tmax) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Terminal half-life (t1/2) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Area Under the Curve Plasma Concentration Time Curve from zero to 24 hours (AUC0-24) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Area Under The Curve Plasma Concentration Time Curve from zero to the time of last plasma concentration (AUC0-t) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Area Under The Curve Plasma Concentration Time Curve from zero to 12 hours (AUC0-12) in a fasting and fed state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Area under the concentration-time curve over the dosing interval (AUC(0-infinity)) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Area under the concentration-time curve for Oral Clearance (CL/F) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (single dose): Area under the concentration-time curve for Volume of Distribution (Vz/F) in a fasting and fed state
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Maximum plasma Concentration (Cmax ss) once steady sate has been reached.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Time to Maximum plasma concentration (Tmax ss) at steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Time to lowest plasma concentration (Cmin ss) at steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Terminal half-life (t1/2 ss) in a steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Area Under The Curve Plasma Concentration Time Curve from zero to the time of last plasma concentration (AUC0-t ss) in a steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Area Under The Curve Plasma Concentration Time Curve from zero to 12 hours (AUC0-12 ss) in a steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Area Under the Curve Plasma Concentration Time Curve from zero to 24 hours (AUC0-24 ss) in a steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Area Under the Curve Plasma Concentration Time (AUC ss) in a steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis (multiple dose): Area under the concentration-time curve for Oral Clearance (CL ss/F) in a steady state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days
Pharmacokinetic Analysis: The geometric mean ratio (GMR) and associated 90% confidence interval (Cl) for Area under the concentration-time curve over the dosing interval (AUC(0-infinity)) in a fasting and fed state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days.
Pharmacokinetic Analysis: The geometric mean ratio (GMR) and associated 90% confidence interval (Cl) for the maximum plasma concentration (Cmax) in a fasting and fed state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days.
Pharmacokinetic Parameters: Accumulation Rate (Rac) of increase in drug concentration in the body after repeated dosing compared to a single dose.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days.
Pharmacokinetic Analysis: Urine concentration data following single and multiple oral dosing in monotherapy.
Measured: Urine PK will be measured during Cycle 1. Cycle 1 is 21 days.
Pharmacokinetic Analysis: Hodges-Lehmann estimate of median difference in tmax and associated 90% CI in a fasted and fed state.
Measured: PK will be measured during Cycle 1. Cycle 1 is 21 days.
Parts B1/B3/B4/B5/B6: Response and disease progression by Serological tumor markers (CA-19-9, CAE, CA-125, and Prostate Specific Antigen (PSA)).
Measured: Tumor markers will be measured for 18 weeks, then every 9 weeks thereafter.
Parts A1, A2, A3, B1, B3, B4: Objective response rate based on RECIST 1.1
Measured: Every 6 weeks from Cycle 1 Day 1 for 18 weeks, then every 9 weeks up to approximately 24 months. Each cycle is 21 days.
Parts A1, A2, A3, B1, B3, B4, B5, and B6: Duration of response based on RECIST 1.1
Measured: Every 6 weeks from Cycle 1 Day 1 for 18 weeks, then every 9 weeks up to approximately 24 months. Each cycle is 21 days.
Parts A1, A2, A3, B1, B3, B4, B5, and B6: Progression free survival based on RECIST 1.1
Measured: Every 6 weeks from Cycle 1 Day 1 for 18 weeks, then every 9 weeks up to approximately 24 months. Each cycle is 21 days.
Parts B1/B3/B4/B5/B6: Overall Survival
Measured: After first dose through PFS/OS follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start27 Jan 2021
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 542 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artios Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Johnson, MD, Study chair, Tennessee OncologyAntonio Gonzalez, MD, PHD, Study chair, Clinica Universidad de Navarra, MadridSusanna Ulahannan, MD, Principal investigator, Oklahoma UniversityKim Reiss Binder, MD, Principal investigator, University of Pennsylvania / Abramson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657068
- Sponsor's protocol ID
- ART0380C001
- Status last verified
- Aug 2026
- First submitted
- 1 Dec 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No