ClinicaliQ Trial Snapshot
- A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors — Recruiting • Phase I • Oncology • NCT04657068.
- Drug Being Tested: ART0380, a novel therapeutic agent being evaluated for safety, tolerability, and efficacy in patients with advanced or metastatic solid tumors, with dose-escalation phases to establish the recommended treatment dose.
- Patient Eligibility Overview: The trial enrolls adults with histologically or cytologically confirmed advanced/metastatic solid tumors who have exhausted standard treatment options or for whom standard treatments are unsuitable; specific performance status and organ function criteria apply.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Eligibility Snapshot
- General Inclusion Criteria: * Signed informed consent * Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment. * If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated * 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 Guidelines (PCWG-3) * Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and granulocyte colony-stimulating factor * Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis. * Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.