A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients with Advanced, Refractory or Recurrent Solid Tumors
A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients with Advanced, Refractory or Recurrent Solid Tumors
Mechanism of Action
AT-1965 is a CMTR2 inhibitor
Purpose
This study is being done to find out if a new investigational drug AT-1965 is safe when given to you, and also look at the pharmacokinetics (PK, to measure how your body takes up, breaks down, and clears AT-1965), Pharmacodynamics (PD, to show that how your body respond to the drug) and the antitumor activity (to measure how AT1965 works in your tumors).
- The patient has a histologically or cytologically confirmed unresectable or metastatic solid tumor that is refractory to standard therapy or for which in the opinion of the investigator no standard therapy is suitable.
- For Part B Dose Expansion in TNBC only: Histologically or cytologically confirmed metastatic triple-negative breast cancer (mTNBC) who had received at least two prior treatments (a taxane and sacituzumab govitecan-hziy) for metastatic disease, for advanced disease. In addition, patients with TNBC with either Low HER2 (IHC 1+ or IHC 2+/in situ hybridization-negative), PD-L1 (CPS>10) or BRCA mutation need to have prior FDA approved available therapies before participation in this expansion arm.
- The patient has an uncontrolled or life-threatening, symptomatic, current or recurrent disease (eg, cardiovascular, renal, hepatic, endocrine) or other abnormality that could affect the action, absorption, or disposition of the study drug, may impact the ability of the patient to participate, may affect clinical or laboratory assessments, or otherwise has the potential to confound the study results.
- History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on chest computed tomography scan in the last 6 months; NOTE: history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Expansion: TNBC only
Location
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