Study of ART0380 in Patients With Biologically Selected Solid Tumors

NCT05798611 | Terminated Phase 2 FDA Drug

• 2 other identifiers: ART0380C0042023-504153-12
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 15

Brief Summary

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).

Conditions

Advanced Solid Tumor; Recurrent Endometrial Cancer; Metastatic Cancer

Keywords

Solid Tumors; Monotherapy; Cancer cell; Oral anti-cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  Until disease progression (Every 6 weeks from randomization Upto 2 Years)

Secondary Outcomes (10)

• Number of patients with adverse events

  From Cycle 1 (each Cycle is 21-day) Day 1 until 30-day follow-up visit (Upto 2 Years)

• Progression free survival (PFS)

  Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

• Best overall response (BOR)

  Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

• Disease control rate (DCR)

  Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

• Duration of response (DOR)

  Screening (≤28 days) Until disease progression or death (Every 6 weeks from randomization Upto 2 Years)

Study Arms (2)

Arm 1 [ART0380 monotherapy (endometrial cancer patients)]

EXPERIMENTAL

Patients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.

Drug: ART0380

Arm 2 [ART0380 monotherapy (solid tumors patients)]

EXPERIMENTAL

Patients with advanced or metastatic solid tumors will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.

Drug: ART0380

Interventions

ART0380 DRUG

Randomized patients will orally receive ART0380.

Arm 1 [ART0380 monotherapy (endometrial cancer patients)]; Arm 2 [ART0380 monotherapy (solid tumors patients)]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have discontinued all previous treatments for cancer for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
• Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, neuropathy, and alopecia, which must have resolved to Grade ≤2).
• Have adequate organ function.
• Patients of childbearing potential and patients with partners of childbearing potential are required to use highly effective contraception.
• Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
• Performance status of 0-1 on the Eastern Cooperative Oncology Group scale.
• Have a non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available.
• Persistent or recurrent EC 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 Programmed cell death protein-1 /Programmed death-ligand-1 inhibitor (e.g., 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.

You may not qualify if:

• Patients who are pregnant.
• Prior treatment with an inhibitor of ATR, WEE1, checkpoint kinase 1 or PKMYT1.
• Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.
• Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.
• Have any major gastrointestinal issues that could impact absorption of ART0380.
• Have a history of allergy or hypersensitivity to study drug components.
• Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
• Patients who plan to father a child while in the study or within 16 weeks (5 months in France) after the last administration of study treatment.

Sponsors & Collaborators

• Artios Pharma Ltd: lead

Study Sites (15)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-1781, United States

Location

The University of Chicago

Chicago, Illinois, 60637-1447, United States

Location

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

Northwell Health R.J. Zuckerberg Cancer Center

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - Oncology

New York, New York, 10065, United States

Location

University of Oklahoma/Sarah Cannon Research Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Institut de Cancérologie de l'Ouest

Angers, NAP, 49055, France

Location

Centre Francois Baclesse - Service d'Oncologie médicale

Caen, NAP, 14076, France

Location

Hopital Cochin Saint Vincent De Paul

Paris, NAP, 75014, France

Location

Hopital Lyon Sud

Pierre-Bénite, NAP, 69310, France

Location

Centre Hospitalier Universitaire De Poitiers

Poitiers, NAP, 86000, France

Location

Hospital Universitario De Jaén

Jaén, Andalusia, 23007, Spain

Location

Fundación Instituto Valenciano De Oncología

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 4, 2023
• Study Start: September 6, 2023
• Primary Completion: November 15, 2024
• Study Completion: May 27, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); US (8); FR (5)