A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Adcentrx Therapeutics
Summary
The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0405 in patients with select advanced solid tumors.
Description
This is a 2-part study. The Phase 1a will consist of a dose escalation of ADRX-0405 to evaluate initial safety and tolerability in patients with select advanced solid tumors \[including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC)\], and to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further evaluate the safety and tolerability, as well as preliminary efficacy, and identify the optimal dose of ADRX-0405 in subjects with previously treated metastatic castration resistant prostate cancer (mCRP…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC). * Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone \< 50 ng/dL \[\< 2.0 nM\]) and that is intolerant/resistant to standard of care (SOC) therapies. * Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects…
Interventions
- DrugADRX-0405
Antibody Drug Conjugate targeting STEAP1
Locations (8)
- City of HopeDuarte, California
- UCLASanta Monica, California
- START MidwestGrand Rapids, Michigan
- University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota
- NEXT AustinAustin, Texas
- The University of Texas MD Anderson Cancer CenterHouston, Texas