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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06036121
Other study ID # ADRX-0706-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 26, 2023
Est. completion date December 2026

Study information

Verified date February 2024
Source Adcentrx Therapeutics
Contact Adcentrx Therapeutics
Phone 858-428-9502
Email clinicaltrials@adcentrx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0706 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-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, 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-0706 in 3 disease-specific expansion cohorts.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date December 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Subjects must have received at least one prior systemic regimen and have no other therapy available known to provide meaningful clinical benefit in the opinion of the investigator. - Measurable disease according to RECIST version 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - 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) - Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior to the first dose of study drug - Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ADRX-0706
Antibody drug conjugate targeting Nectin-4

Locations

Country Name City State
United States START Midwest Grand Rapids Michigan
United States University of Texas MD Anderson Cancer Center Houston Texas
United States UCLA Los Angeles California
United States USC Norris Comprehensive Cancer Center Los Angeles California
United States START San Antonio San Antonio Texas
United States START Mountain Region West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
Adcentrx Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Until study completion (estimated 3 years)
Secondary Measurement of maximum plasma concentration (Cmax) of ADRX-0706 Measured from pharmacokinetic (PK) blood samples Until study completion (estimated 3 years)
Secondary Measurement of trough concentration (Ctrough) of ADRX-0706 Measured from PK blood samples Until study completion (estimated 3 years)
Secondary Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706 Measured from PK blood samples Until study completion (estimated 3 years)
Secondary Measurement of terminal half-life (t1/2) of ADRX-0706 Measured from PK blood samples Until study completion (estimated 3 years)
Secondary Measurement of systemic clearance (CL) of ADRX-0706 Measured from PK blood samples Until study completion (estimated 3 years)
Secondary Measurement of volume of distribution at steady state (Vss) of ADRX-0706 Measured from PK blood samples Until study completion (estimated 3 years)
Secondary Incidence of anti-drug antibodies (ADA) Measured from ADA blood samples Until study completion (estimated 3 years)
Secondary 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 3 years)
Secondary 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 3 years)
Secondary Measurement of disease control rate (DCR) Percentage of subjects achieving CR, PR or stable disease (SD) Until study completion (estimated 3 years)
Secondary 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 3 years)
Secondary Measurement of overall survival (OS) Time from the start of study drug until death from any cause Until study completion (estimated 3 years)
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