Solid Tumor Clinical Trial
Official title:
A Phase 1/2 Dose Escalation Study of AP-002 In Patients With Advanced or Recurrent Solid Tumors
The purpose of this trial is to define an effective and safe dose of AP-002 in advanced or recurrent solid tumors for which there are no standard therapies to use in subsequent studies in advanced or recurrent breast, non-small cell lung cancer (NSCLC) or prostate cancers.
The Phase 1 portion of this study will determine the Pharmacodynamically Active Dose (PAD) of
AP-002 in humans, defined as the dose at which the plasma concentration of AP-002, as
measured by Ga, is 300-500 ng/mL and which is at or below the Maximum Tolerated Dose (MTD),
to use in the clinical setting of advanced or recurrent solid tumors. This will be followed
by a Phase 2 expanded cohort treated at the PAD, to estimate the efficacy of AP-002 in
patients with advanced or recurrent breast cancer, NSCLC and prostate cancer.
Patients will receive AP-002 orally, once daily for 14 days of a 21 day cycle.
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