CompletedPhase 1

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

United States, United Kingdom93 participantsStarted 2021-09-13

Plain-language 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 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib

Timeframe: 21 days (Cycle 1)

Part B1 and B2: Number of participants with adverse events following administration of ART4215

Timeframe: 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

Timeframe: 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.

Trial details

NCT IDNCT04991480

SponsorArtios Pharma Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-24

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