Study of ART0380 for Patients with Specific Solid Tumors

Sponsor: Artios Pharma Ltd

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05798611

Provider View

This clinical trial is testing a new oral cancer treatment, ART0380, to see if it is safe and effective for patients with certain types of solid tumors that may respond to this treatment.

Patient Parameters

Program Overview

The study is exploring the use of ART0380, an oral medication, for treating patients with advanced or metastatic solid tumors that have specific biological characteristics. The goal is to determine if ART0380 can effectively treat these cancers by targeting a protein involved in DNA repair. Patients with persistent or returning endometrial cancer and those with other advanced solid tumors will be included. Participants will be randomly assigned to one of two different dose regimens of ART0380. The safety of the treatment will be regularly monitored, and patients can continue the treatment as long as it is beneficial and they do not experience severe side effects.

Description

ART0380 is a new oral medication being tested for its ability to treat cancers that have problems with DNA repair. This study will include patients with advanced or metastatic solid tumors, such as those with persistent or returning endometrial cancer, and other types of solid tumors. Participants will be randomly assigned to receive one of two different doses of ART0380.

The study will regularly check the safety of ART0380, and patients can continue taking it as long as it helps them and they do not have unacceptable side effects. Patients will stop the treatment if their cancer progresses, they choose to withdraw, or they experience severe side effects related to the drug.

Eligibility Criteria

Inclusion Criteria

  • Must have stopped all previous cancer treatments for at least 21 days or 5 half-lives, whichever is shorter, except for palliative radiotherapy, which must have been completed 1 week before starting the study treatment.
  • Any side effects from previous treatments or surgeries must have improved to baseline or mild levels, except for certain conditions like hypothyroidism, neuropathy, and hair loss, which must be mild to moderate.
  • Must have good organ function.
  • Patients and their partners must use highly effective birth control.
  • Must have an expected life expectancy of at least 12 weeks.
  • Must have a performance status score of 0-1, indicating full activity or some restriction in strenuous activities.
  • Must provide a tumor tissue sample that has not been treated with radiation.

Specific Criteria for Arm 1 (Endometrial Cancer Patients):

  • Must have persistent or returning endometrial cancer with specific biological characteristics.
  • Should have received taxane/platinum chemotherapy unless not suitable.
  • Must have measurable disease.

Specific Criteria for Arm 2 (Solid Tumors Patients):

  • Must have advanced or metastatic solid tumors with specific biological characteristics.
  • If a PD-1/PD-L1 inhibitor is approved for their cancer, they should have received it before joining the study.
  • Must have disease that can be evaluated by scans.

Exclusion Criteria

  • Pregnant patients.
  • Previous treatment with ATR, WEE1, checkpoint kinase 1, or PKMYT1 inhibitors.
  • Serious health conditions that would prevent following the study protocol.
  • Ongoing lung disease or inflammation.
  • Patients with treated brain metastases can join if follow-up scans show no progression.
  • Major gastrointestinal issues affecting drug absorption.
  • History of allergy to study drug components.
  • Significant bleeding disorders or recent severe bleeding episodes.
  • Use of certain medications affecting liver enzymes or drug absorption within 2 weeks before starting the study.
  • Planning to father a child during the study or within 16 weeks after the last dose.

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