A Phase 1/2 Trial of ADI-212 in mCRPC

Prior treatment

• Prior radiation therapy within 21 days prior to start of study treatment
• Prior positive superscan results \[i.e.: an imaging appearance on a Tc-99m diphosphonate bone scan\]
• Current or history of any of the following conditions or treatments:
  • Presence of known central nervous system (CNS) metastases
  • History of clinically significant infection
  • Active malignancy within the past 24 months
  • Any other condition requiring treatment with a prohibited medication, as specified in the protocol
  • Prior treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy
  • Prior PSMA-targeted therapies other than a single course of a PSMA-targeted radioligand therapy
• Prior CAR-T therapy
• Prior solid organ transplant

Other illness

• Clinically significant cardiovascular disease

Lab values

• Any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of study treatment

Other

• Unwilling to participate in an extended safety monitoring period

• Histologic and/or cytologic confirmation of adenocarcinoma of the prostate
• Documented evidence of metastatic disease.
• Target lesions must be PSMA-avid by PET/CT, based on local determination.
• Must have castration testosterone level (\< 50 ng/dL) and must remain on androgen deprivation therapy (ADT) to maintain this level.
• Progressive mCRPC based on at least one of the following:
  • PSA progression defined as two increases in PSA measured at least one week apart
  • Soft-tissue progression defined per PCWG3
  • Bone disease progression defined per PCWG3
• Evaluable target lesions, per PCWG3
• ECOG of 0 or 1
• Prior therapy :
  • Participants must have progressed after at least two prior courses of systemic ADT.
  • Participants may have had no more than one course of prior taxane therapy.
  • Prio PSMA-targeted radioligand therapy (e.g., Pluvicto) is permitted.
  • Prior PARP inhibitor therapy is permitted.
  • Must have prior therapy washout, including investigational agents, of at least three weeks for prior systemic therapies other than androgen deprivation therapies, or five half-lives if the duration is shorter than three weeks.
• Adequate BP, hematological, and organ function