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Study of ART6043 in Advanced/Metastatic Solid Tumors Patients
EU CTIS ID: 2023-509220-17-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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
- Specific to Part A2: Patients for whom a PARPi is an appropriate treatment option. Patients may have received prior treatment with a PARPi.
- Specific to Part B: Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.
- Specific to Part B: Documentation of a deleterious or suspected deleterious gBRCA mutation.
- 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.
You likely can't join if
- 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.
- Known hypersensitivity/history of allergy to any of the components of ART6043 or olaparib.
- Specific to Part B: First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.
- Specific to Part B: Inflammatory breast cancer.
- Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.
- Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
See the full eligibility criteria
Who can join
- 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
- 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
- Specific to Part A2: Patients for whom a PARPi is an appropriate treatment option. Patients may have received prior treatment with a PARPi.
- Specific to Part B: Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.
- Specific to Part B: Documentation of a deleterious or suspected deleterious gBRCA mutation.
- 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.
- Specific to Part B: Prior treatment with a taxane (if appropriate) in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.
- 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.
- Resolution of all toxicities of prior therapy or surgical procedures.
- Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have adequate organ function
- 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
- Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
- Specific to Part A1: Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes
- Specific to Part A1 for Spain only: Patient that is not eligible for curative treatment, for whom standard of care therapies have failed.
- 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).
What rules you out
- 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.
- Known hypersensitivity/history of allergy to any of the components of ART6043 or olaparib.
- Specific to Part B: First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.
- Specific to Part B: Inflammatory breast cancer.
- Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.
- Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Have ongoing interstitial lung disease or pneumonitis.
- Have any major gastrointestinal issues that could impact absorption of ART6043 or Olaparib.
- 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).
- Have received a live vaccine within 30 days before the first dose of study treatment.
- 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.
- Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.