Advanced CancerPhase 1NCT04991480
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
A Phase 1 study testing ART4215, Talazoparib and Niraparib in people with Advanced Cancer and Metastatic Cancer, run by Artios Pharma Ltd at 8 sites in 2 countries.
Trial summary
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib Learn more about the side effects of ART4215… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer, Breast Cancer
- What is being tested?
- ART4215, Talazoparib and Niraparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 13 Sep 2021to 24 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- Signed informed consent
- Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter (except in Germany where local regulation requires the longer of 21 days or 5 half-lives washout), and recovered from the acute effects of therapy. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
- At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 (PCWG-3) for patients with prostate cancer
- Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor
- Willingness to abide by protocol defined contraceptive requirements for the duration of the study.
- Estimated life expectancy of ≥12 weeks
Additional inclusion criteria for participants in dose escalation (Part A1):
- Advanced or metastatic cancer, which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis
Additional inclusion criteria for participants in dose escalation (Part A2):
- Advanced or metastatic cancer for which a PARP inhibitor is an appropriate treatment option. Participants may have received prior treatment with PARP inhibitor
- Optional baseline biopsy for BRCA1/2 mutations and prior PARP inhibitor
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis
Additional inclusion criteria for participants in dose escalation (Part A3):
- Advanced or metastatic cancer for which a PARP inhibitor is an appropriate treatment option. Prior treatment with PARP inhibitor
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis
Additional inclusion criteria for participants in dose expansion (Part B1):
- Advanced or metastatic solid tumors that have undergone disease progression during treatment with a PARP inhibitor for an approved indication
- At least 1 measurable lesion assessable using standard techniques by RECIST v1.1 or PCWG-3 guidelines
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis
Additional inclusion criteria for participants in dose expansion (Part B2):
- Advanced or metastatic cancer that is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study with characteristics indicative of sensitivity to pol theta inhibition
- No prior treatment with a PARP inhibitor and must not have a disease for which there is an approved PARP inhibitor
- At least 1 measurable lesion assessable using standard techniques by RECIST v1.1 or PCWG-3 guidelines
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis
Additional inclusion criteria for participants in dose expansion (Part B3):
- HER2-negative locally advanced or metastatic breast cancer
- Deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 mutation
- No more than 3 prior chemotherapy-inclusive regimens (including antibody conjugates)
- Prior treatment with a taxane or anthracycline unless contraindicated
- No or </= 1 month of prior treatment with a PARP inhibitor
- At least 1 measurable lesion assessable using standard techniques by RECIST v1.1
- Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis
General Exclusion Criteria:
- Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within the protocol defined timeframe after the last administration of study specified treatment.
- Men who plan to father a child while in the study or within the protocol defined timeframe after the last administration of study specified treatment.
- Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: opportunistic HIV/AIDs-related infection(s) within the past 12 months, hepatitis B virus, or hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated [including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)] that is not in remission
- Have MDS/AML or features suggestive of MDS/AML
- Ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic)
- Moderate or severe cardiovascular disease
- Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment; stable brain metastases are eligible
- Received a live vaccine within 30 days before the first dose of study treatment
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate
- Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study
- Significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment
- Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Additional exclusion criteria for participants in dose expansion (Part B3):
- First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy
- Inflammatory breast cancer
- Known hypersensitivity to any of the components of talazoparib
- Prior treatment with a PARP inhibitor that was discontinued due to a treatment related toxicity.
Additional exclusion criteria for participants in dose escalation (Part A3):
- Hypersensitivity to any of the components of niraparib
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology
Nashville, Tennessee, 37203
Yale School of Medicine
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Oklahoma University
Oklahoma City, Oklahoma, 73104
Florida Cancer Specialists
Orlando, Florida, 32827
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United Kingdom1 site
Sarah Cannon Research Institute
London, England, UK/W1G 6AD
About this study
Official title: A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
- Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib
- Learn more about the side effects of ART4215 alone and in combination with talazoparib
- Learn more about the effectiveness of ART4215 alone and in combination with talazoparib
- Learn more about the effectiveness of ART4215 alone and in combination with niraparib
Read the detailed description
This is an open-label Phase I/IIa study designed to evaluate ART4215, a new first-in-class investigational medicinal product that is a potent and selective inhibitor of deoxyribonucleic acid (DNA) polymerase (pol) theta. ART4215 is being developed as an oral anti-cancer agent for monotherapy treatment of patients with cancers that harbor defects in DNA repair and in combination with anticancer medicines that cause DNA damage.
This study was intended to be a Phase I/IIa trial, however the trial did not proceed to the Phase IIa portion of the study.
- Conditions
- Advanced Cancer, Metastatic Cancer, Breast Cancer
- Being tested
- ART4215, Talazoparib, Niraparib
- Keywords
- Sensitivity to pol theta inhibition, Germline Breast Cancer gene mutation, gBRCA-m, BRCA1, BRCA2, Human epidermal growth factor receptor 2 negative, HER2 negative
- Medical subject headings
- Neoplasm Metastasis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART4215Drug
Participants will receive ART4215 by mouth daily in 21-day cycles.
TalazoparibDrug
Also called Talzenna
Talazoparib will be administered at a dose of 1 mg or 0.75 mg by mouth daily in 21-day cycles.
NiraparibDrug
Also called Zejula
Niraparib will be administered at a dose of 200 mg or 300 mg by mouth daily in 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 | Experimental | Part A1 will evaluate ART4215 monotherapy administered in 21 day cycles. Up to 90 participants will participate in this dose escalation arm. Receives: Drug: ART4215 |
| Part A2 | Experimental | Part A2 will evaluate ART4215 given in combination with talazoparib in 21 day cycles. Up to 50 participants will participate in this dose escalation arm. Receives: Drug: ART4215; Drug: Talazoparib |
| Part B1 | Experimental | In Part B1 dose expansion, up to 30 participants with solid cancers that have been treated with a PARP inhibitor for an approved indication will receive ART4215. Receives: Drug: ART4215 |
| Part B2 | Experimental | In Part B2 dose expansion, up to 20 participants with solid cancers with characteristics indicative of sensitivity to pol theta inhibition will receive ART4215. Receives: Drug: ART4215 |
| Part B3 | Experimental | In Part B3, approximately 120 participants with HER2 negative BRCA breast cancers will be randomized 1:1 to either ART4215 in combination with talazoparib or talazoparib alone. Receives: Drug: ART4215; Drug: Talazoparib |
| Part A3 | Experimental | Part A3 will evaluate ART4215 given in combination with niraparib in 21-day cycles. Up to 30 participants will participate in this dose escalation arm. Receives: Drug: ART4215; Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib
DLTs are defined as adverse events (graded according to NCI CTCAE v5.0) during Cycle 1 that are related to ART4215 monotherapy, in combination with talazoparib or in combination with niraparib
Measured: 21 days (Cycle 1)
Part B1 and B2: Number of participants with adverse events following administration of ART4215
Number of adverse events as characterized by type, frequency, seriousness (graded according to NCI CTCAE v5.0) and relationship to ART4215
Measured: From the first dose until up to 30 days after the last dose of ART4215. Each cycle is 21 days.
Part B3: Progression free survival (PFS) as a measure of efficacy for ART4215 in combination with talazoparib or talazoparib alone
PFS is defined as the time from the start of randomization until the earliest objective disease progression defined by RECIST v1.1 or death by any cause in the absence of progression.
Measured: Every 6 weeks (±7 days) from date of randomization for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Secondary outcomes (21)
Part B3: Number of participants with adverse events following administration of ART4215 in combination with talazoparib
Number of adverse events as characterized by type, frequency, seriousness (graded according to NCI CTCAE v5.0) and relationship to ART4215 in combination with talazoparib
Measured: From the first dose until up to 30 days after the last dose of ART4215. Each cycle is 21 days.
Best overall response (BOR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
BOR will be calculated as the best response from date study treatment started until progression or censoring date in the absence of progression. BOR will be based on RECIST v1.1 and Prostate Cancer Working Group-3 (PCWG-3) (for prostate cancer).
Measured: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Objective response rate (ORR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
ORR is defined as the proportion of patients who have a best response of either complete response (CR) or partial response (PR) based on RECIST v1.1 or PCWG-3. Response must be confirmed (at least two responses of CR or PR a minimum of 4 weeks apart and prior to progression/subsequent therapy) for Parts A, B1 and B2.
Measured: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Disease control rate (DCR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
DCR is defined as the proportion of patients with CR, PR, or SD based on RECIST v1.1 or PCWG-3.
Measured: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Duration of response (DOR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
DOR will be defined for patients with a BOR of CR/PR as the time from the date of first documented response until date of documented progression (by RECIST v1.1 or PCWG-3) or death in the absence of disease progression. BOR should be confirmed in Parts A, B1, and B2.
Measured: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Change in tumor size as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Change in tumor size will be assessed for all patients with target lesion measurements at baseline.
Measured: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Parts A, B1, and B2: Progression free survival (PFS) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
PFS is defined as the time from the start of study treatment until the earliest objective disease progression defined by RECIST v1.1 or PCWG-3 or death by any cause in the absence of progression.
Measured: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Overall survival (OS) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
OS is defined as the time from the start of study treatment until death due to any cause.
Measured: Assessed every 12 weeks after treatment discontinuation for up to 24 months.
Pharmacokinetic Analysis (single dose): maximum plasma concentration (Cmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): time to maximum plasma concentration (tmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): maximum plasma concentration (Cmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): time to maximum plasma concentration (tmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): area under the concentration-time curve over the dosing interval (AUC tau) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Measured: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): maximum plasma concentration (Cmax) of ART4215 when given with or without food
Measured: 8 days (Cycle 0)
Part A2: Pharmacokinetic Analysis (multiple dose): maximum steady state plasma concentration (Cmax ss) of talazoparib when given in combination with ART4215
Measured: 1 day (Cycle 2 Day 1; Cycle 2 is 21 days)
Pharmacokinetic Analysis (single dose): time to maximum plasma concentration (tmax) of ART4215 when given with or without food
Measured: 8 days (Cycle 0)
Pharmacokinetic Analysis (single dose): area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) of ART4215 when given with or without food
Measured: 8 days (Cycle 0)
Assessment of lesions in (or indicative of lesions in) DNA repair pathways by immunohistochemistry for loss of shieldin complex and/or TP53BP1 or other relevant pathways
Measured: Within 28 days prior to the first dose of ART4215.
Pharmacokinetic Analysis (Part A1): renal clearance of ART4215 monotherapy will be calculated as the cumulative amount of ART4215 excreted unchanged in the urine (Ae) divided by the appropriate AUC.
Measured: PK will be measured on Cycle 0 Day -4 and Cycle 1 Day 8. Cycle 0 is 4 days. Cycle 1 is 21 days.
Pharmacokinetic Analysis (Parts A2/B3) : renal clearance of ART4215 in combination with talazoparib will be calculated as the cumulative amount of ART4215 excreted unchanged in the urine (Ae) divided by the appropriate AUC.
Measured: PK will be measured on Cycle 1 Day 1 and Cycle 1 Day 8. Cycle 1 is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start13 Sep 2021
- Primary completion24 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artios Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erika Hamilton, MD, Study chair, Tennessee OncologyTimothy Yap, MBBS, PhD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991480
- Sponsor's protocol ID
- ART4215C001
- Status last verified
- Jan 2026
- First submitted
- 19 Jul 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04991480
- Acronym / sponsor ID
- ART4215C001
- Conditions
- Advanced Cancer, Metastatic Cancer, Breast Cancer
- Keywords
- Sensitivity to pol theta inhibition, Germline Breast Cancer gene mutation, gBRCA-m, BRCA1, BRCA2, Human epidermal growth factor receptor 2 negative, HER2 negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Artios Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
- Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib
- Learn more about the side effects of ART4215 alone and in combination with talazoparib
- Learn more about the effectiveness of ART4215 alone and in combination with talazoparib
- Learn more about the effectiveness of ART4215 alone and in combination with niraparib
Detailed description
This is an open-label Phase I/IIa study designed to evaluate ART4215, a new first-in-class investigational medicinal product that is a potent and selective inhibitor of deoxyribonucleic acid (DNA) polymerase (pol) theta. ART4215 is being developed as an oral anti-cancer agent for monotherapy treatment of patients with cancers that harbor defects in DNA repair and in combination with anticancer medicines that cause DNA damage.
This study was intended to be a Phase I/IIa trial, however the trial did not proceed to the Phase IIa portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A1 | Experimental | Drug: ART4215Part A1 will evaluate ART4215 monotherapy administered in 21 day cycles. Up to 90 participants will participate in this dose escalation arm. |
| Part A2 | Experimental | Drug: ART4215, Drug: TalazoparibPart A2 will evaluate ART4215 given in combination with talazoparib in 21 day cycles. Up to 50 participants will participate in this dose escalation arm. |
| Part B1 | Experimental | Drug: ART4215In Part B1 dose expansion, up to 30 participants with solid cancers that have been treated with a PARP inhibitor for an approved indication will receive ART4215. |
| Part B2 | Experimental | Drug: ART4215In Part B2 dose expansion, up to 20 participants with solid cancers with characteristics indicative of sensitivity to pol theta inhibition will receive ART4215. |
| Part B3 | Experimental | Drug: ART4215, Drug: TalazoparibIn Part B3, approximately 120 participants with HER2 negative BRCA breast cancers will be randomized 1:1 to either ART4215 in combination with talazoparib or talazoparib alone. |
| Part A3 | Experimental | Drug: ART4215, Drug: NiraparibPart A3 will evaluate ART4215 given in combination with niraparib in 21-day cycles. Up to 30 participants will participate in this dose escalation arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART4215Participants will receive ART4215 by mouth daily in 21-day cycles. | Drug | Part A1, Part A2, Part A3, Part B1, Part B2, Part B3 |
| TalazoparibAlso: TalzennaTalazoparib will be administered at a dose of 1 mg or 0.75 mg by mouth daily in 21-day cycles. | Drug | Part A2, Part B3 |
| NiraparibAlso: ZejulaNiraparib will be administered at a dose of 200 mg or 300 mg by mouth daily in 21-day cycles. | Drug | Part A3 |
Primary outcome
Part A: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: 21 days (Cycle 1)
DLTs are defined as adverse events (graded according to NCI CTCAE v5.0) during Cycle 1 that are related to ART4215 monotherapy, in combination with talazoparib or in combination with niraparib
Part B1 and B2: Number of participants with adverse events following administration of ART4215
Time frame: From the first dose until up to 30 days after the last dose of ART4215. Each cycle is 21 days.
Number of adverse events as characterized by type, frequency, seriousness (graded according to NCI CTCAE v5.0) and relationship to ART4215
Part B3: Progression free survival (PFS) as a measure of efficacy for ART4215 in combination with talazoparib or talazoparib alone
Time frame: Every 6 weeks (±7 days) from date of randomization for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
PFS is defined as the time from the start of randomization until the earliest objective disease progression defined by RECIST v1.1 or death by any cause in the absence of progression.
21 secondary outcomes
Part B3: Number of participants with adverse events following administration of ART4215 in combination with talazoparib
Time frame: From the first dose until up to 30 days after the last dose of ART4215. Each cycle is 21 days.
Best overall response (BOR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Objective response rate (ORR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Disease control rate (DCR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Duration of response (DOR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Change in tumor size as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Parts A, B1, and B2: Progression free survival (PFS) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Every 6 weeks (±7 days) from the first dose for 18 weeks, then every 9 weeks (±7 days) up to approximately 24 months. Each cycle is 21 days.
Overall survival (OS) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib
Time frame: Assessed every 12 weeks after treatment discontinuation for up to 24 months.
Pharmacokinetic Analysis (single dose): maximum plasma concentration (Cmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Time frame: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): time to maximum plasma concentration (tmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Time frame: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Time frame: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): maximum plasma concentration (Cmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Time frame: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): time to maximum plasma concentration (tmax) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Time frame: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (multiple dose): area under the concentration-time curve over the dosing interval (AUC tau) of ART4215 when given alone, in combination with talazoparib or in combination with niraparib
Time frame: PK will be measured at each cycle from Cycle 0 to Cycle 3, and then every third cycle beginning at Cycle 5 for up to approximately 24 months. Each cycle is 21 days.
Pharmacokinetic Analysis (single dose): maximum plasma concentration (Cmax) of ART4215 when given with or without food
Time frame: 8 days (Cycle 0)
Part A2: Pharmacokinetic Analysis (multiple dose): maximum steady state plasma concentration (Cmax ss) of talazoparib when given in combination with ART4215
Time frame: 1 day (Cycle 2 Day 1; Cycle 2 is 21 days)
Pharmacokinetic Analysis (single dose): time to maximum plasma concentration (tmax) of ART4215 when given with or without food
Time frame: 8 days (Cycle 0)
Pharmacokinetic Analysis (single dose): area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)) of ART4215 when given with or without food
Time frame: 8 days (Cycle 0)
Assessment of lesions in (or indicative of lesions in) DNA repair pathways by immunohistochemistry for loss of shieldin complex and/or TP53BP1 or other relevant pathways
Time frame: Within 28 days prior to the first dose of ART4215.
Pharmacokinetic Analysis (Part A1): renal clearance of ART4215 monotherapy will be calculated as the cumulative amount of ART4215 excreted unchanged in the urine (Ae) divided by the appropriate AUC.
Time frame: PK will be measured on Cycle 0 Day -4 and Cycle 1 Day 8. Cycle 0 is 4 days. Cycle 1 is 21 days.
Pharmacokinetic Analysis (Parts A2/B3) : renal clearance of ART4215 in combination with talazoparib will be calculated as the cumulative amount of ART4215 excreted unchanged in the urine (Ae) divided by the appropriate AUC.
Time frame: PK will be measured on Cycle 1 Day 1 and Cycle 1 Day 8. Cycle 1 is 21 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Hamilton, MD study chair
Tennessee Oncology
Timothy Yap, MBBS, PhD study chair
M.D. Anderson Cancer Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ART4215, Talazoparib and Niraparib in people with Advanced Cancer and Metastatic Cancer, run by Artios Pharma Ltd at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib (time frame: 21 days (Cycle 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.