A Study of ADRX-0706 in Select Advanced Solid Tumors

Solid Tumors Clinical Trial

Official title:

A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036121
• Other study ID #: ADRX-0706-001
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

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)