ART6043 for Metastatic solid tumors | Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- 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\n- 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\n- Specific to Part A2: Patients for whom a PARPi is an appropriate treatment option. Patients may have received prior treatment with a PARPi.\n- Specific to Part B: Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.\n- Specific to Part B: Documentation of a deleterious or suspected deleterious gBRCA mutation.\n- 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.\n- Specific to Part B: Prior treatment with a taxane (if appropriate) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.\n- 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.\n- Resolution of all toxicities of prior therapy or surgical procedures.\n- Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale\n- Have adequate organ function\n- 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\n- Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.\n- Specific to Part A1: Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes\n- Specific to Part A1 for Spain only: Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.\n- 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)."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Known hypersensitivity/history of allergy to any of the components of ART6043 or olaparib.\n- Specific to Part B: First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.\n- Specific to Part B: Inflammatory breast cancer.\n- Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.\n- Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.\n- Have ongoing interstitial lung disease or pneumonitis.\n- Have any major gastrointestinal issues that could impact absorption of ART6043 or Olaparib.\n- 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).\n- Have received a live vaccine within 30 days before the first dose of study treatment.\n- 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.\n- Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment."}

Primary endpoints

• {"endpoint_text":"- Part A: Incidence of Dose Limiting Toxicities (DLTs); incidence and severity of Adverse Events (CTCAE v5.0)","definition_or_measurement_approach":"DLTs incidence; adverse events graded and reported using CTCAE v5.0"}
• {"endpoint_text":"- Part B2: Progression free survival (PFS) (based on RECIST v1.1)","definition_or_measurement_approach":"Progression-free survival measured according to RECIST v1.1"}

Secondary endpoints

• {"endpoint_text":"- Part B2: Incidence and severity of Adverse events (CTCAE v5.0)","definition_or_measurement_approach":"Adverse events graded and reported using CTCAE v5.0"}
• {"endpoint_text":"- Best overall response (BOR), Objective Response Rate (ORR), Disease control rate (DCR), Duration of response (DOR) and change in tumor size","definition_or_measurement_approach":""}
• {"endpoint_text":"- Serological tumor markers","definition_or_measurement_approach":""}
• {"endpoint_text":"- Part A: Progression free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- ART6043 and ART7276 plasma concentration data","definition_or_measurement_approach":"Plasma concentration measurement (pharmacokinetic sampling)"}
• {"endpoint_text":"- Olaparib plasma concentration data","definition_or_measurement_approach":"Plasma concentration measurement (pharmacokinetic sampling)"}
• {"endpoint_text":"- Archival tumor or pre-dose tumor biopsy","definition_or_measurement_approach":"Collection of archival tumor tissue or pre-dose tumor biopsy for biomarker analyses"}

Spain

Earliest CTIS Part Ii Submission Date

28-06-2024

Latest Decision Or Authorization Date

06-04-2026

Processing Time Days

647

Number Of Sites

20

Number Of Participants

55

Primary sponsor

Full Name

Artios Pharma Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 3, 7; email: info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties codes: 4; contact email: Lynn.Bromley@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"sponsorDuties codes: 4; contact email: biopharma_samples@guardanthealth.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Fundacion Grupo Espanol De Investigacion En Cancer De Mama","duties_or_roles":"sponsorDuties codes: 1, 14, 15 (value: 'Trial start up activities. Site Contracting, Investigator Payments. Provision of translation services.'), 5, 8; contact email: geicam@geicam.org","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"Sarah Cannon Research Institute LLC","duties_or_roles":"sponsorDuties codes: 8; contact email: CANN.SAE@scri-innovations.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sponsorDuties codes: 4; contact email: martina.alken@azenta.com","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Allucent (NL) B.V.","duties_or_roles":"sponsorDuties codes: 1,13,15 (value: 'Site contracting, Investigator Payments'), 2,5,7; contact email: SSUReg@allucent.com","organisation_type":"Pharmaceutical company"}