Ph1b Participants with Metastatic Castration-Resistant Prostate Cancer
Research type
Research Study
Full title
A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination with Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination with Olaparib in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
IRAS ID
283981
Contact name
Elisa Fontana
Contact email
Sponsor organisation
Opna-IO LLC
Eudract number
2020-002021-28
Clinicaltrials.gov Identifier
151,392, IND Number
Duration of Study in the UK
3 years, 7 months, 0 days
Research summary
This research study is a multicenter, open label, phase 1b/2a study of PLX2853 in combination with Abiraterone and Prednisone in subjects with metastatic Castration-Resistant Prostate Cancer (mCRPC) who are progressing on treatment with abiraterone and prednisone alone.
Phase 1b of this study is intended to assess the safety and tolerability of PLX2853 in combination with abiraterone and prednisone. Phase 2a of this study is intended to evaluate the effectiveness of PLX2853 in combination with abiraterone and prednisone.
Up to 15 participants will be enrolled in the phase 1b. Three participants will be assigned the same dose level of PLX2853 to take with abiraterone and prednisone. If this dose level is tolerated, 3 additional participants will be assigned a higher dose of PLX2853. This will be repeated until the recommended phase 2 dose (RP2D) is determined. All patients will receive the same starting dose of abiraterone and prednisone. Once the RP2D is found, up to 19 participants will be enrolled in the phase 2a.
Eligible participants are males 18 years or older who meet the study entry criteria. Before treatment, participants will undergo screening to confirm they meet eligibility. Once enrolled participants will receive daily treatment on a 21 day cycle and remain on treatment until their disease worsens, they experience unacceptable side effects, or they decide they no longer want to participate. After completing treatment participants will enter follow-up, where information on their disease will continue to be collected. In the first 2 cycles, participants will have additional clinic visits to assess for safety and perform additional research procedures.
There is a separate ph1b/2a portion of this study that will evaluate PLX2853 in combination with olaparib, but this is not currently applicable to the UK.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0967
Date of REC Opinion
24 Sep 2020
REC opinion
Further Information Favourable Opinion