Solid Tumors
Conditions
Brief 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.
Detailed 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 (mCRPC).
Interventions
DRUGADRX-0405
Antibody Drug Conjugate targeting STEAP1
Sponsors
Adcentrx Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 with prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b * Adequate hematologic, liver, and renal function
Exclusion criteria
* Active and uncontrolled central nervous system metastases * Significant cardiovascular disease * History of another malignancy other than the one for which the subject is being treated on this study within 3 years * Receipt of any anticancer or investigational therapy within: 5 elimination half-lives or 14 days (whichever is less); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer * History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Until study completion (estimated 2 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of progression free survival (PFS) | Until study completion (estimated 2 years) | Time from the start of study drug until first evidence of PD or death from any cause |
| Measurement of radiographic progression free survival (rPFS) | Until study completion (estimated 2 years) | Time from the start of study drug until first radiographic documentation of PD, or death from any cause, whichever comes first |
| Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405 | Until study completion (estimated 2 years) | Measured from pharmacokinetic (PK) blood samples |
| Measurement of trough concentration (Ctrough) of ADRX-0405 | Until study completion (estimated 2 years) | Measured from PK blood samples |
| Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405 | Until study completion (estimated 2 years) | Measured from PK blood samples |
| Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate | Until study completion (estimated 2 years) | Measured from PK blood samples |
| Measurement of overall survival (OS) | Until study completion (estimated 2 years) | Time from the start of study drug until death from any cause |
| Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405 | Until study completion (estimated 2 years) | Measured from PK blood samples |
| Incidence of anti-drug antibody (ADA) to ADRX-0405 | Until study completion (estimated 2 years) | Measured from ADA blood samples |
| Measurement of objective response rate (ORR) per RECIST 1.1 | Until study completion (estimated 2 years) | Percentage of subjects achieving complete response (CR) or partial response (PR) |
| ORR per Prostate Cancer Working Group 3 (PCWG3) | Until study completion (estimated 2 years) | Percentage of subjects achieving complete response (CR) or partial response (PR) |
| Measurement of duration of response (DOR) | Until study completion (estimated 2 years) | Time from first response until first evidence of disease progression (PD) or death from any cause |
| Measurement of disease control rate (DCR) | Until study completion (estimated 2 years) | Percentage of subjects achieving CR, PR or stable disease (SD) |
| Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405 | Until study completion (estimated 2 years) | Measured from PK blood samples |
Countries
United States
Contacts
Primary ContactAdcentrx Therapeutics
Outcome results
None listed