What is Aza-TdC studying for advanced solid tumors?

Aza-TdC is being studied to understand its safety and the best dose to give to people with advanced solid tumors that have not responded to standard treatments. Researchers aim to see if this drug can reactivate genes that slow tumor growth. The National Cancer Institute sponsors this trial to explore new treatment options.

Who may be eligible for this advanced solid tumors clinical trial?

Adults aged 18 and older with solid tumors that have worsened after standard therapy or have no effective treatment may be eligible. Participants must have good organ and marrow function and be able to swallow pills. Both men and women can join, with contraceptive measures required for those who can have children. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumors clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join.

Actively Recruiting

Phase 1

Age: 18Years - 120Years

All Genders

ID03366116

Phase I Trial of 5-aza-4-Thio-2-Deoxycytidine Aza-TdC in Patients With Advanced Solid Tumors

Led by National Cancer Institute (NCI) · Updated on 2026-06-05

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new drug called Aza-TdC in people with advanced solid tumors whose cancer has worsened after standard treatments or for whom no effective treatment exists. The research aims to find out the safety, tolerability, and the best dose of this drug to give to patients. Aza-TdC works by targeting gene silencing mechanisms involved in cancer growth, potentially reactivating genes that slow tumor growth. Participants will take Aza-TdC by mouth in cycles of 21 days. In each cycle, they take the drug once daily for 5 days in week 1 and 5 days in week 2, followed by a week without the drug. The first cycle includes repeated screening tests, while later cycles involve blood and pregnancy tests, and tumor scans every 6 weeks. Treatment continues as long as the drug is tolerated and the cancer does not worsen. During the study, participants undergo medical history reviews, blood and urine tests, heart activity tests, and tumor scans. Researchers monitor safety, drug levels in the body, gene activity in tumor cells, and DNA changes in tumor tissue. The main goal is to determine the safety and best dose of Aza-TdC, while also studying its effects on tumors and gene expression. Participants stay in the study until treatment is no longer appropriate or cancer progresses.

CONDITIONS

Brief Title

5-aza-4'-Thio-2'-Deoxycytidine (Aza-TdC) in People With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 120Years

All Genders

Eligibility Criteria

You may qualify if you...

Patients with histologically confirmed solid tumors that have progressed on standard therapy or lack effective therapy
Age 18 years or older
ECOG performance status of 2 or less
Normal organ and bone marrow function as defined by specific blood counts and liver and kidney tests
Agreement to use two forms of contraception during and for 3 months after study participation if of child-bearing potential
Completion of prior chemotherapy or biologic therapy at least 4 weeks before enrollment
Ability to understand and sign informed consent
Willingness to provide blood and urine samples for research
Ability to swallow pills or capsules
Left ventricular ejection fraction greater than 45% or within institutional normal limits
For expansion cohort, tumor must be suitable for biopsy and willingness to undergo biopsies

You will not qualify if you...

Receiving other investigational agents
Pregnant or breastfeeding women
Clinically significant illnesses that may interfere with study participation, including uncontrolled infections, immune deficiencies, HIV needing certain therapy, hepatitis B or C, uncontrolled diabetes or hypertension, heart failure, recent heart attack, arrhythmia, or psychiatric/social conditions limiting compliance
Known primary central nervous system malignancy or symptomatic CNS metastases, except certain controlled or asymptomatic cases
Malabsorption syndrome or conditions interfering with intestinal absorption

Research Team

DTC Referral Coordinators

James H Doroshow, M.D.

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