A Study of ADRX-0706 in Select Advanced Solid Tumors

Study Overview
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Brief Summary
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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-0706 in patients with select advanced solid tumors.

Detailed Description
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: ADRX-0706


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1a Dose Escalation<br>Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part. | Drug: ADRX-0706<br>* Antibody drug conjugate targeting Nectin-4<br>|
| Experimental: Phase 1b Dose Expansion<br>ADRX-0706 will be initially administered at the dose recommended from the Phase 1a part in 3 disease-specific cohorts. | Drug: ADRX-0706<br>* Antibody drug conjugate targeting Nectin-4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Until study completion (estimated 3 years) | 

Secondary Outcome Measures

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