Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Solid Tumors, Neoplasms, ADRX-0706

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA accepting new patients
    Los Angeles California 90404 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Adcentrx Therapeutics
ID
NCT06036121
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 144 study participants
Last Updated