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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a Dose Escalation | Experimental | Increasing doses of ADRX-0405 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part. |
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| Phase 1b Dose Expansion | Experimental | ADRX-0405 will be initially administered at the dose recommended from the Phase 1a part in subjects with previously treated mCRPC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADRX-0405 | Drug | Antibody Drug Conjugate targeting STEAP1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Until study completion (estimated 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405 | Measured from pharmacokinetic (PK) blood samples | Until study completion (estimated 2 years) |
| Measurement of trough concentration (Ctrough) of ADRX-0405 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adcentrx Therapeutics | Contact | 858-428-9502 | clinicaltrials@adcentrx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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Measured from PK blood samples |
| Until study completion (estimated 2 years) |
| Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405 | Measured from PK blood samples | Until study completion (estimated 2 years) |
| Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate | Measured from PK blood samples | Until study completion (estimated 2 years) |
| Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405 | Measured from PK blood samples | Until study completion (estimated 2 years) |
| Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405 | Measured from PK blood samples | Until study completion (estimated 2 years) |
| Incidence of anti-drug antibody (ADA) to ADRX-0405 | Measured from ADA blood samples | Until study completion (estimated 2 years) |
| Measurement of objective response rate (ORR) per RECIST 1.1 | Percentage of subjects achieving complete response (CR) or partial response (PR) | Until study completion (estimated 2 years) |
| ORR per Prostate Cancer Working Group 3 (PCWG3) | Percentage of subjects achieving complete response (CR) or partial response (PR) | Until study completion (estimated 2 years) |
| Measurement of duration of response (DOR) | Time from first response until first evidence of disease progression (PD) or death from any cause | Until study completion (estimated 2 years) |
| Measurement of disease control rate (DCR) | Percentage of subjects achieving CR, PR or stable disease (SD) | Until study completion (estimated 2 years) |
| Measurement of progression free survival (PFS) | Time from the start of study drug until first evidence of PD or death from any cause | Until study completion (estimated 2 years) |
| Measurement of radiographic progression free survival (rPFS) | Time from the start of study drug until first radiographic documentation of PD, or death from any cause, whichever comes first | Until study completion (estimated 2 years) |
| Measurement of overall survival (OS) | Time from the start of study drug until death from any cause | Until study completion (estimated 2 years) |
| UCLA | Recruiting | Santa Monica | California | 90404 | United States |
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| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
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| University of Minnesota Masonic Cancer Center | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| NEXT Austin | Recruiting | Austin | Texas | 78758 | United States |
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| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| START Mountain Region | Recruiting | West Valley City | Utah | 84119 | United States |
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| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
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