AT03-65 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called AT03-65 for individuals with advanced solid tumors. The goal is to determine the treatment's safety, how the body processes it, and its initial effectiveness. It targets those whose cancer has not responded to standard treatments or who cannot tolerate them, such as certain types of ovarian or lung cancer. Participants should have measurable tumors and good organ function, and they must not have had recent cancer treatments or certain other health issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires that you stop taking any systemic anti-cancer therapy at least 4 weeks before starting the study drug. Additionally, you cannot take certain medications that affect liver enzymes (CYP2C8 or CYP3A inhibitors or inducers) or P-glycoprotein inhibitors within 14 days before the trial and during the study.
Is there any evidence suggesting that AT03-65 is likely to be safe for humans?
Research has shown that AT03-65 is safe in animal studies. Specifically, tests on monkeys indicated that the treatment was generally well-tolerated. These studies also demonstrated promising effects against tumors, offering hope for future cancer treatment. Since AT03-65 is now in the early stages of human testing, researchers are still carefully studying its safety. Currently, safety information comes only from animal studies, and more research is needed to determine how well people tolerate it.12345
Why do researchers think this study treatment might be promising?
Unlike the standard cancer treatments, which often include chemotherapy or radiation, AT03-65 is unique because it focuses on a novel approach by being administered intravenously in a 21-day cycle. Researchers are excited about AT03-65 as it introduces a potentially new mechanism of action that targets cancer cells differently than current therapies. This innovative delivery method may offer more targeted treatment, potentially reducing side effects and improving effectiveness compared to conventional options.
What evidence suggests that AT03-65 might be an effective treatment for cancer?
Research has shown that AT03-65 targets cancer cells with a marker called CLDN6. Early studies indicate that it not only kills these specific cancer cells but also affects nearby cancer cells, potentially improving treatment outcomes for patients with these cancers. Initial results are promising, suggesting AT03-65 might be effective against advanced solid tumors. This treatment is currently being tested in this trial to determine its safety and effectiveness for people.14678
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that are resistant or have no further standard treatments available. Participants must have a good performance status, measurable lesions, and specific CLDN6 expression in their tumors. Prior treatment regimens are acceptable, but fresh tumor samples or archival blocks for testing are required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive AT03-65 via intravenous infusion on Day 1 of a 21-Day treatment cycle to identify the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT)
Dose Expansion
Further evaluation of AT03-65 at or below the MTD to identify the recommended Phase 2 dose (RP2D)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AT03-65
Trial Overview
The study tests AT03-65's safety and effectiveness on various advanced solid tumors. It's a first-in-human Phase I trial assessing how the body processes the drug (pharmacokinetics), its action in the body (pharmacodynamics), and initial signs of its effectiveness.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects will receive AT03-65 via intravenous (IV) infusion on Day 1 of a 21-Day treatment cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axcynsis Therapeutics Pte Ltd
Lead Sponsor
Citations
NCT06809114 | FIH Study to Evaluate Safety, Tolerability, ...
... efficacy of AT03-65 in adults with advanced solid tumors. AT03-65 is administered via intravenous infusion using an accelerated escalation method for the ...
Axcynsis Therapeutics Receives FDA Clearance for IND ...
AT03-65 is designed to deliver targeted therapy to improve patient outcomes with advanced or metastatic CLDN6-positive cancers. “This is a ...
Axcynsis Therapeutics Receives FDA Clearance for IND ...
Preclinical studies demonstrate that AT03-65 not only directly kill CLDN6-positive tumor cells but also exhibits bystander killing effect, ...
4.
pharmaceutical-business-review.com
pharmaceutical-business-review.com/news/fda-axcynsis-at03-65-ind/FDA clears Axcynsis' AT03-65 IND for CLDN6-positive ...
According to preclinical studies, AT03-65 eliminates CLDN6-positive malignant cells as well as exhibits a bystander effect. Promising results ...
FIH Study to Evaluate Safety, Tolerability, PK, PD & ...
Determine the presence of antibodies to AT03-65 at different times in plasma, Assess immunogenicity concentration in peripheral blood, Maximum 2 years.
Axcynsis Therapeutics Receives FDA Clearance for IND ...
AT03-65 has demonstrated promising anti-tumor activities in multiple tumor mouse models and a favorable safety profile in non-human primates.
7.
bioworld.com
bioworld.com/articles/716366-axcynsis-gains-ind-clearance-for-at03-65-for-cldn6-positive-solid-tumorsAxcynsis gains IND clearance for AT03-65 for CLDN6 ...
AT03-65 has demonstrated promising antitumor activities in multiple tumor mouse models and a favorable safety profile in nonhuman primates ( ...
8.
trial.medpath.com
trial.medpath.com/news/f7a14b388eec2944/axcynsis-therapeutics-receives-fda-clearance-for-ind-application-of-at03-65Axcynsis Therapeutics' AT03-65, a CLDN6-Targeting ADC ...
Axcynsis Therapeutics received FDA clearance for its IND application for AT03-65, an ADC targeting CLDN6-positive solid tumors, marking a key regulatory ...
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