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AT-1965 for Cancer
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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Area under the concentration-time curve from zero to 168 hours [AUC(0-168)]
Area under the concentration-time curve from zero to 24 hours
Area under the concentration-time curve from zero to a definite time [AUC(0-t)]
+12 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AT-1965 Liposome InjectionExperimental Treatment1 Intervention
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