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

Adicet Therapeutics

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Prostate Cancer Metastatic

Treatments: Drug: ADI-212; Drug: Cyclophosphamide; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07793435

ADI-212-001

Details and patient eligibility

About

This is a Phase 1/2 multicenter, open-label, dose finding and dose expansion study of ADI-212 in participants with metastatic castration-resistant prostate cancer (mCRPC)

Enrollment: 12 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. PSA progression defined as two increases in PSA measured at least one week apart
  2. Soft-tissue progression defined per PCWG3
  3. Bone disease progression defined per PCWG3

• Evaluable target lesions, per PCWG3

• ECOG of 0 or 1

• Prior therapy :

  1. Participants must have progressed after at least two prior courses of systemic ADT.
  2. Participants may have had no more than one course of prior taxane therapy.
  3. Prio PSMA-targeted radioligand therapy (e.g., Pluvicto) is permitted.
  4. Prior PARP inhibitor therapy is permitted.
  5. 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

Exclusion criteria

• 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:

  1. Presence of known central nervous system (CNS) metastases
  2. History of clinically significant infection
  3. Active malignancy within the past 24 months
  4. Any other condition requiring treatment with a prohibited medication, as specified in the protocol
  5. Prior treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy
  6. Prior PSMA-targeted therapies other than a single course of a PSMA-targeted radioligand therapy

• Prior CAR-T therapy

• Clinically significant cardiovascular disease

• Prior solid organ transplant

• Unwilling to participate in an extended safety monitoring period

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Dose Escalation

Experimental group

Description:

ADI-212 is administered via infusion using the 3 + 3 design starting with three planned dose levels to determine the maximum tolerated dose (MTD or maximum assessed dose (MAD)

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: ADI-212

Dose Expansion

Experimental group

Description:

Dose Expansion to assess the anti-tumor responses to ADI-212 at the recommended Phase 2 dose (Part 2)

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: ADI-212