100 Participants Needed

AUBE00 for Cancer

Recruiting at 3 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AUBE00 for individuals with advanced solid tumors. It aims to determine the treatment's safety, how the body processes it, and its potential to reduce tumor size. The study consists of two parts: initially, it tests different doses to establish safety, then it applies those doses to a larger group. Individuals with a KRAS gene change in their cancer who have not responded to standard treatments might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AUBE00 is likely to be safe for humans?

Research has shown that AUBE00 has been tested in patients with solid tumors to assess its safety and tolerability. Patients have taken varying doses, adjusted to ensure safety, including determining the maximum tolerated dose (MTD), the highest dose without serious side effects.

Studies have found that patients take AUBE00 orally, and researchers closely monitor for any negative effects. Although specific side effects are not detailed, the emphasis on safe dosing indicates careful observation of patient responses.

As this is the first human trial of AUBE00, the primary goal is to understand its safety. Researchers continue to gather information on potential side effects and overall safety. The study includes regular check-ups to detect any issues early.12345

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments that often involve chemotherapy or radiation, AUBE00 is unique because it’s taken orally and works by targeting specific cancer pathways. Researchers are excited about AUBE00 because it potentially offers a more precise treatment option with fewer side effects than traditional methods. Moreover, AUBE00’s ability to be administered at multiple dose levels allows for flexibility in treatment, which could lead to better customization based on individual patient needs. This innovative approach could transform how we manage and treat cancer, making it a promising option for the future.

What evidence suggests that AUBE00 might be an effective treatment for cancer?

Research shows that AUBE00 is a promising new treatment for patients with solid tumors. Early lab studies have demonstrated AUBE00's potential to effectively target and control tumor growth. Initial data suggest that this pill could help prevent cancer from growing or spreading for a longer time. Although human studies provide limited information, AUBE00 is designed to specifically attack cancer cells, which may lead to better outcomes for patients. The treatment aims to be well-tolerated, with manageable side effects. Participants in this trial will receive AUBE00 in different parts: Part A involves dose escalation to determine safe levels, and Part B involves expansion at multiple dose levels, including the maximum tolerated dose (MTD).23467

Who Is on the Research Team?

SC

Sponsor Chugai Pharmaceutical Co.Ltd

Principal Investigator

clinical-trials@chugai-pharm.co.jp

Are You a Good Fit for This Trial?

This trial is for people with advanced or widespread solid tumors. Around 70 to 100 patients will be accepted. Specific eligibility details are not provided, but typically participants must meet certain health standards and have a type of tumor that the study targets.

Inclusion Criteria

I am fully active or can carry out light work.
My cancer has a KRAS mutation.
My condition hasn't improved with standard treatments or there are none available.
See 1 more

Exclusion Criteria

I have had a stroke or similar brain issue in the last 6 months.
Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study or within 27 weeks after the last dose of AUBE00
I do not have an active brain tumor or untreated brain metastases needing treatment.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients receive AUBE00 as an oral administration at escalated doses to determine the maximum tolerated dose (MTD)

Approximately 4-6 weeks
Multiple visits for dose escalation and monitoring

Dose Expansion

Patients receive AUBE00 at multiple dose levels determined to be safe, including the MTD

Approximately 6-12 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 49 months

What Are the Treatments Tested in This Trial?

Interventions

  • AUBE00
Trial Overview The trial is testing AUBE00, a new treatment for solid tumors. It's an early-stage (Phase I) study looking at how safe it is, what side effects it has, and how well it works against cancer. The trial also measures how the body processes the drug.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part B: Expansion partExperimental Treatment1 Intervention
Group II: Part A: Dose Escalation partExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Chugai Pharmaceutical

Lead Sponsor

Trials
105
Recruited
25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University

Citations

Chugai Pharmaceutical's AUBE00 Study: A Potential Game ...Its primary purpose is treatment-focused, aiming to gather preliminary data on AUBE00's effectiveness and safety. The study began on May 11 ...
Study of AUBE00 in Patients With Solid TumorsOverview. This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, ...
AUBE00 for Cancer · Recruiting Participants for Phase ...This Phase 1 medical study run by Chugai Pharmaceutical is evaluating whether AUBE00 will have tolerable side effects & efficacy for patients with Solid Tumors.
Study of AUBE00 in Patients With Solid TumorsA Phase 1 study of AUBE00 in solid tumors. A first-in-human study to evaluate the safety and effectiveness of an investigational drug called AUBE00 in patients ...
Development Pipeline | Investor Relations | CHUGAI ...RG6114 is an investigational, oral targeted treatment that could provide well-tolerated, durable disease control and potentially improved outcomes for people ...
Study of AUBE00 in Patients With Solid TumorsPatients will receive AUBE00 as an oral administration at multiple dose levels determined to be safe (including MTD). Treatment: Drug: AUBE00 ...
Conjugates dominate human trial entries | ApexOncoAUBE00 ... Just two other anti-FGFR2b ADCs are in clinical testing, according to OncologyPipeline, and given the Fortitude-101 result safety will ...
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