Study of ART6043 in Advanced/​Metastatic Solid Tumors Patients

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

10 Apr 2026 → ongoing

Decision date (initial)

2024-07-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-509220-17-00

ClinicalTrials.gov

NCT05898399

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Others, Safety

Part A: To assess the safety and tolerability of ART6043 given orally in patients with advanced or metastatic solid tumors and to determine the MTD and/or RP2D(s) of ART6043 as monotherapy and in combination with olaparib.

Part B2: To assess preliminary signs of efficacy with ART6043 in combination with olaparib compared to olaparib alone in patients with HER2-ve locally advanced or metastatic breast cancer with a gBRCA mutation.

Secondary objectives 5

1. Part B2: To further assess the safety and tolerability of ART6043 given orally in combination with olaparib at the RP2D(s).
2. To assess preliminary signs of efficacy for ART6043 as monotherapy and in combination with olaparib.
3. To determine the PK of ART6043 and its potential active metabolite ART7276 following both single and multiple oral dosing of ART6043 monotherapy and following multiple oral dosing of ART6043 in combination with olaparib.
4. To explore the effect of ART6043 on the PK of olaparib
5. To assess markers in pre-dose tumor samples that may be predictive of the activity of ART6043.

Conditions and MedDRA coding

Metastatic solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 16

1. Have discontinued all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Endocrine and hormonal therapies for the treatment of cancer must have been discontinued (unless for the treatment of Prostate Cancer) at least 7 days before receiving study medication. Palliative radiotherapy must have completed prior to start of study treatment
2. Resolution of all toxicities of prior therapy or surgical procedures.
3. Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
4. Have adequate organ function
5. Patients of childbearing potential and patients with partners of childbearing potential must be willing to follow contraceptive requirements during their participation in the study and for the appropriate period after the last dose of study drug
6. Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
7. Specific to Part A1: Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes
8. Specific to Part A1 for Spain only: Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.
9. Specific to Part A1/A2: At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation (prostate cancer patients only).
10. Specific to Part A2: Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes based on available, pre-existing testing
11. Specific to Part A2: Patients for whom a PARPi is an appropriate treatment option. Patients may have received prior treatment with a PARPi.
12. Specific to Part B: Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.
13. Specific to Part B: Documentation of a deleterious or suspected deleterious gBRCA mutation.
14. Specific to Part B: Patients must have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor positive breast cancer must have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
15. Specific to Part B: Prior treatment with a taxane (if appropriate) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.
16. Specific to Part B: Patients must have received no or ≤1 month of prior treatment with a PARPi. Patients receiving any prior PARPi must not have progressed on treatment.

Exclusion criteria 12

1. Patients who are pregnant (lack of pregnancy confirmed by a urine or serum pregnancy test within 5 days prior to receiving first dose of study treatment in patients of childbearing potential) or breast feeding.
2. Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.
3. Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
4. Have ongoing interstitial lung disease or pneumonitis.
5. Have any major gastrointestinal issues that could impact absorption of ART6043 or Olaparib.
6. Patients with brain metastases (patients with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression).
7. Have received a live vaccine within 30 days before the first dose of study treatment.
8. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access), or minor surgery within 1 week of entry into the study.
9. Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
10. Known hypersensitivity/history of allergy to any of the components of ART6043 or olaparib.
11. Specific to Part B: First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.
12. Specific to Part B: Inflammatory breast cancer.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Part A: Incidence of Dose Limiting Toxicities (DLTs); incidence and severity of Adverse Events (CTCAE v5.0)
2. Part B2: Progression free survival (PFS) (based on RECIST v1.1)

Secondary endpoints 8

1. Part B2: Incidence and severity of Adverse events (CTCAE v5.0)
2. Best overall response (BOR), Objective Response Rate (ORR), Disease control rate (DCR), Duration of response (DOR) and change in tumor size
3. Serological tumor markers
4. Part A: Progression free survival (PFS)
5. Overall survival (OS)
6. ART6043 and ART7276 plasma concentration data
7. Olaparib plasma concentration data
8. Archival tumor or pre-dose tumor biopsy

Investigational products

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

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Artios Pharma Limited

Sponsor organisation

Artios Pharma Limited

Address

Babraham Hall, Babraham Research Campus Babraham Research Campus

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 7

Locations

1 EU/EEA country · 20 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

Documents 11 files

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

Application history

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