Open Actively Recruiting

A Study of ADRX-0706 in Select Advanced Solid Tumors

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

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