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AT-1965 Liposome Injection for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Alyssum Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 9 month

Awards & highlights

Study Summary

This trial is testing a new drug called AT-1965 in patients with advanced solid tumors to find the highest safe dose and to see how the drug works in the body. The study will also look

Who is the study for?

This trial is for adults with advanced solid tumors that are not removable by surgery or have spread, and which haven't responded to standard treatments. Participants must have recovered from previous treatment side effects (except hair loss) and should be relatively fit (ECOG status of 0 or 1). They need at least one tumor that can be measured on scans, adequate blood counts, kidney function, and liver enzymes within certain limits.Check my eligibility

What is being tested?

The study tests AT-1965 Liposome Injection in patients with tough-to-treat solid tumors. It's a Phase 1/2 trial aiming to find the highest dose patients can take without serious side effects (MTD), decide on a recommended dose for future studies (RP2D), understand how the drug behaves in the body (PK/PD), and see if it shrinks tumors.See study design

What are the potential side effects?

Since this is an early-stage trial for AT-1965, specific side effects aren't listed yet. Generally, such trials look out for any signs of toxicity like nausea, fatigue, allergic reactions or organ-specific issues as they gradually increase doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 9 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 9 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 9 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose Limiting Toxicity (DLT) according to CTCAE version 5.0 in Part A - Dose Escalation Phase

Duration of Response (DoR) based on RECIST version 1.1 in Part B - Dose Expansion Phase

Objective Response Rate (ORR) based on RECIST version 1.1 in Part B - Dose Expansion Phase

Secondary outcome measures

Area under the concentration-time curve from zero to a definite time [AUC(0-t)]

Area under the concentration-time curve from zero to an infinite time [AUC(0-inf)]

Area under the concentration-time curve from zero to last measurable [AUC(0-last)]

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AT-1965 Liposome InjectionExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Alyssum TherapeuticsLead Sponsor

CBCC Global ResearchNETWORK

7 Previous Clinical Trials

1,198 Total Patients Enrolled

Richard Fahrner, PhDStudy DirectorAlyssum Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing research study?

"According to details on clinicaltrials.gov, this study is actively seeking volunteers. The trial was first listed on 2/13/2024 and last amended on 3/18/2024."

Answered by AI

In how many distinct locations is this investigation currently being conducted?

"The ongoing clinical trial operates in 6 sites, with Bakersfield, El Segundo, and Dallas among the locations. It is advised to choose a site close by to reduce travel requirements when joining the study."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical trial?

"We are in need of 85 eligible participants to join this research endeavor. Candidates meeting the outlined criteria may enroll at various locations such as CBCC Global Research Site 005 situated in Bakersfield, California or CBCC Global Research Site 007 located in El Segundo, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors

2024. "Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06234098.

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