An Open-label, Multi-center, First in Human Phase I Global Dose Escalation and Expansion Study of INR731 Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer (CINR731A12101)

未提供0 个研究点目标入组 4 人开始时间: 待定

适应症

试验速览

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•An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =<
•Participants must have histological and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are eligible as long as the non-adenocarcinoma feature is the minority component.
•At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained =<28 days prior to Cycle 1 Day 1 (C1D1).
•Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
•Ongoing androgen deprivation therapy (ADT) either via orchiectomy and/or ongoing gonadotropin-releasing hormone (GnRH) analog or inhibitor is allowed.
•Participants must be mCRPC patients who have either progressed on or are not candidates for other SOC. Prior taxane, poly (ADP) ribose polymerase (PARP) inhibitor, and lutetium Lu 177 vipivotide tetraxetan (Pluvicto) are allowed. Combination expansion patients, however, must be 1L mCRPC with no prior treatment in the mCRPC setting. Treatment within the mHSPC setting does not affect eligibility.

•Age < 18 years old.
•Histological and/or cytological confirmation of non-adenocarcinoma of the prostate.
•Patients with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan) are not eligible.
•Patients previously treated with a cereblon-based degrader.
•Patients who are HIV+ or immune compromised.
•Use of agents known to prolong QT interval unless they can be permanently discontinued for the duration of the study.
•Treatment with an investigational agent within 7 days (or 5 half-lives, whichever is longer) of the anticipated Cycle 1 Day 1 (C1D1).

发起方

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