Study of ART0380 in Advanced/Metastatic Solid Tumors Patients (ARTIST)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Artios Pharma Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

7 Dec 2023 → 27 May 2025

Decision date (initial)

2023-11-02

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Artios Pharma Limited

External identifiers

EU CT number

2023-504153-12-00

ClinicalTrials.gov

NCT05798611

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacogenetic, Safety, Dose response, Pharmacogenomic, Pharmacodynamic, Therapy, Pharmacokinetic, Efficacy

To determine the efficacy of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.

Secondary objectives 3

1. To assess the safety and tolerability of ART0380 in patients with solid tumors.
2. To further explore the efficacy of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.
3. To determine the PK of ART0380 following both single and multiple oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.

Conditions and MedDRA coding

Advanced or Metastatic Solid Tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. ≥18 years of age.
2. 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.
3. 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).
4. Have adequate organ function.
5. Patients of childbearing potential and patients with partners of childbearing potential are required to use highly effective contraception.
6. Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
7. Performance status of 0-1 on the ECOG scale.
8. Have a sufficient non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available.
9. Persistent or recurrent Endometrial Cancer with biological selection. (Arm 1)
10. Patients should have received taxane/platinum chemotherapy, unless contraindicated. (Arm 1)
11. Measurable disease. (Arm 1)
12. Advanced or metastatic solid cancers of any histology with biological selection. (Arm 2)
13. If a PD-1/PDL-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. (Arm 2)
14. Radiologically evaluable disease. (Arm 2)

Exclusion criteria 11

1. Patients who are pregnant.
2. Prior treatment with an inhibitor of ATR, WEE1, CHK1 or PKMYT1.
3. Have a serious concomitant systemic disorder that would compromise the patient’s ability to adhere to the protocol.
4. Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
5. Patients with treated brain metastases are eligible if followup brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.
6. Have any major GI issue that could impact absorption of ART0380.
7. Have a history of allergy or hypersensitivity to study drug components.
8. Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
9. Patients receiving potent inhibitors and inducers of CYP3A4 or CYP3A4 substrates which have a narrow therapeutic range or CYP3A4 sensitive substrates within 2 weeks before the first dose of study treatment will be excluded.
10. Patients receiving the following within 2 weeks of the first dose will be excluded from study treatment. a. PgP or BCRP inhibitors. b. statins.
11. Patients who plan to father a child while in the study or within 16 weeks after the last administration of study treatment. (Arm 2)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective Response Rate (ORR).

Secondary endpoints 3

1. Incidence and severity of AEs
2. Progression free survival (PFS), best overall response (BOR), disease control rate (DCR), duration of response (DOR) and change in tumor size (based on RECIST v1.1). Overall survival (OS, collected until the time of data cut-off).
3. Plasma concentration data.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Artios Pharma Limited

Sponsor organisation

Artios Pharma Limited

Address

Babraham Hall, Babraham Babraham

City

Cambridge

Postcode

CB22 3AT

Country

United Kingdom

Scientific contact point

Organisation

Artios Pharma Limited

Contact name

Chief Medical Officer

Public contact point

Organisation

Artios Pharma Limited

Contact name

Chief Medical Officer

Third parties 12

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications