Clinical trial NCT06710379: A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Official title: A Phase 1a/b Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Adcentrx Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Until study completion (estimated 2 years)
Secondary outcomes:
measure: Measurement of End of Infusion or observed maximum blood concentration (Ceoi orCmax) of ADRX-0405
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of trough concentration (Ctrough) of ADRX-0405
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of area under the blood concentration-time curve (AUC) of ADRX-0405
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of partial area under the concentration-time curve after first dose (AUC0-21) of ADRX-0405 and as appropriate
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of terminal or apparent terminal half-life (t1/2) of ADRX-0405
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of systemic clearance (CL) and volume of distribution at steady state (Vss) as appropriate of ADRX-0405
timeFrame: Until study completion (estimated 2 years)
measure: Incidence of anti-drug antibody (ADA) to ADRX-0405
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of objective response rate (ORR) per RECIST 1.1
timeFrame: Until study completion (estimated 2 years)
measure: ORR per Prostate Cancer Working Group 3 (PCWG3)
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of duration of response (DOR)
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of disease control rate (DCR)
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of progression free survival (PFS)
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of radiographic progression free survival (rPFS)
timeFrame: Until study completion (estimated 2 years)
measure: Measurement of overall survival (OS)
timeFrame: Until study completion (estimated 2 years)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
city: Austin
country: United States
facility: NEXT Austin
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Fairfax
country: United States
facility: NEXT Virginia
state: Virginia
Study officials:
References: