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

ConditionProstate Cancer Metastatic

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexMale

Age18+

SponsorAdicet Therapeutics

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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]

Presence of known central nervous system (CNS) metastases

History of clinically significant infection

Trial design

Design model

Single group

Treatments tested in this trial

ADI-212
Drug
Allogeneic cell therapy
Fludarabine
Drug
Chemotherapy for Lymphodepletion
Cyclophosphamide
Drug
Chemotherapy for Lymphodepletion

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: Dose EscalationExperimental treatment 3 interventions

Group B: Dose ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

The incidence of Subjects with Dose Limiting Toxicity within each dose level

The primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed Dose (MAD) and Recommended Phase 2 Dose (RP2D)

Time frame

Day 42

Proportion of treatment emergent and treatment related Adverse Events

This primary endpoint will be used to determine Overall Response Rate (ORR) per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 per local assessment and Radiographic progression-free survival (rPFS)

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adicet Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: