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New treatment option for Refractory Malignant Solid Neoplasm
Official title AOH1996 for the Treatment of Refractory Solid Tumors
ClinicalTrials.gov ID: NCT05227326
What this study is testing
What is PCNA Inhibitor AOH1996?
PCNA Inhibitor AOH1996 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for refractory malignant solid neoplasm.
Also referred to as AOH 1996, AOH-1996.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed Consent and Willingness to Participate
- 1\. Documented informed consent by the participant
- 2\. Willingness to permit study team to obtain and use archival tissue, if already existing Age Criteria, Performance Status and Life Expectancy
- 3\. Age: ≥ 18 years
- 4\. ECOG performance status ≤ 2
You likely can't join if
- Concomitant Medications/Therapies \_\_1. Dietary/herbal supplements
- 2\. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
- 3\. Warfarin
- 4\. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
- 5\. Strong inhibitors or inducers of CYP2C9
- 6\. Strong inhibitors or inducers of CYP3A Other Illnesses and Conditions
See the full eligibility criteria
- Informed Consent and Willingness to Participate
- 1\. Documented informed consent by the participant
- 2\. Willingness to permit study team to obtain and use archival tissue, if already existing Age Criteria, Performance Status and Life Expectancy
- 3\. Age: ≥ 18 years
- 4\. ECOG performance status ≤ 2
- 5\. Life expectancy of \> 3 months Nature of Illness and Treatment History \_\_6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR...
- 8\. ANC ≥ 1,500/mm3
- 9\. Platelets ≥ 100,000/mm3 :
- 10\. Total serum bilirubin ≤ 1.5 x ULN
- 11\. AST =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
- 12\. ALT =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
- 13\. Creatinine clearance of ≥ 60 mL/min per 24 hour urine or the Cockcroft-Gault
- 14\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Concomitant Medications/Therapies \_\_1. Dietary/herbal supplements
- 2\. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
- 3\. Warfarin
- 4\. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
- 5\. Strong inhibitors or inducers of CYP2C9
- 6\. Strong inhibitors or inducers of CYP3A Other Illnesses and Conditions
- 7\. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
- 8\. Women who are or are planning to become pregnant or breastfeed
- 9\. Known allergy to any of the components within the study agents and/or their excipients.
- 10\. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is...
- 11\. Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.