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ADRX-0706 for Cancer

Phase 1

Recruiting

Research Sponsored by Adcentrx Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until study completion (estimated 3 years)

Awards & highlights

Study Summary

This trial tests a new drug to see if it's safe and effective for advanced solid tumors. It seeks to identify the best dose.

Who is the study for?

This trial is for people with certain advanced solid tumors who have tried at least one treatment but don't have other options that could help. They should be relatively healthy and active (ECOG status 0 or 1) and have measurable disease. Cancers included are urothelial, head & neck, breast, cervical, ovarian, lung (NSCLC), and pancreatic cancer.Check my eligibility

What is being tested?

ADRX-0706 is being tested to find the safest dose that can be tolerated by patients with specific advanced solid tumors. The study will also look at how the body processes this drug.See study design

What are the potential side effects?

While not specified here, common side effects in trials like this may include fatigue, nausea, diarrhea, decreased appetite and potential risks related to liver or kidney function due to the nature of anticancer drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced cancer, such as breast, lung, or ovarian cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until study completion (estimated 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until study completion (estimated 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until study completion (estimated 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Incidence of anti-drug antibodies (ADA)

Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706

Measurement of disease control rate (DCR)

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 1b Dose ExpansionExperimental Treatment1 Intervention

ADRX-0706 will be initially administered at the dose recommended from the Phase 1a part in 3 disease-specific cohorts.

Group II: Phase 1a Dose EscalationExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Adcentrx TherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research actively seeking participants at present?

"This research project is in its recruitment phase, with the first posting of information on September 1st 2023 and a recent update made on September 12th."

Answered by AI

How many healthcare facilities are engaged in this clinical investigation?

"This trial is currently in progress at 4 sites, such as Grand Rapids, San Antonio and West Valley City. To minimize the burden of travelling to the clinic, those interested should consider enrolling near their residence."

Answered by AI

Has the FDA sanctioned Phase 1a Dose Escalation?

"Our team at Power gave Phase 1a Dose Escalation a score of 1, due to the fact that it is only in its preliminary stages and there is limited evidence supporting safety or effectiveness."

Answered by AI

What is the size of this clinical trial's participant pool?

"To complete this clinical trial, 114 qualified applicants will be needed. START Midwest in Grand Rapids, Michigan and START San Antonio in San Antonio, Texas are two of the participating locations for patient recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of ADRX-0706 in Select Advanced Solid Tumors

2023. "A Study of ADRX-0706 in Select Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036121.