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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
Must not have
Active and uncontrolled central nervous system metastases
Significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until study completion (estimated 3 years)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new drug called ADRX-0706 in patients with advanced cancers. It aims to find out if the drug is safe, what side effects it might have, and the best dose to use.
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.
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.
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 belowSelect...
I have advanced cancer, such as breast, lung, or ovarian cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to my brain and is not under control.
Select...
I have a serious heart condition.
Select...
I have not had any other cancer besides the one I'm being treated for in the last 3 years.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Targeted therapies, such as those inhibiting specific proteins or pathways (e.g., HER2, VEGF), aim to block the growth and spread of cancer cells with fewer side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells, often by targeting immune checkpoints like PD-1/PD-L1.
These mechanisms are crucial for patients with advanced solid tumors as they offer different strategies to control tumor growth, improve survival, and maintain quality of life. ADRX-0706, likely a novel agent, may offer a new mechanism or an improved approach within these categories, potentially providing better outcomes for patients with advanced solid tumors.
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Who is running the clinical trial?
Adcentrx TherapeuticsLead Sponsor
1 Previous Clinical Trials
68 Total Patients Enrolled