NCT06234098 · Alyssum Therapeutics
Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors
What this study is about
This is a first-in-human, conducted at multiple hospitals, where both patients and doctors know the treatment given, gradually increasing doses and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, how the drug moves through the body (PK), how the drug affects the body, and preliminary antitumor activity of AT-1965 in patients with advanced, refractory or recurrent solid tumors (nonresectable and/or metastatic) including mTNBC.
View original scientific description
This is a first-in-human, multicenter, open-label, dose escalation and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of AT-1965 in patients with advanced, refractory or recurrent solid tumors (nonresectable and/or metastatic) including mTNBC.
Interventions
DRUG
AT-1965 Liposome Injection
AT-1965 Liposome Injection administered intravenously once weekly for the first 3 weeks (Days 1, 8 and 15) of a 4 week cycle.
Primary outcome measures
Dose Limiting Toxicity (DLT) according to CTCAE version 5.0 in Part A - Dose Escalation Phase
Time frame: Dose limiting toxicities will be evaluated during the first treatment cycle (28 days)
Nature and frequency of dose-limiting toxicities (DLTs) associated with AT-1965 administration, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Objective Response Rate (ORR) based on RECIST version 1.1 in Part B - Dose Expansion Phase
Time frame: 3, 6 and 9 month
Objective Response Rates (ORR) defined as proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to RECISTv1.1 as assessed by the Investigator
Duration of Response (DoR) based on RECIST version 1.1 in Part B - Dose Expansion Phase
Time frame: 3, 6 and 9 month
Duration of response (DoR) defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented according to RECIST v1.1 as assessed by the Investigator.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The patient has a histologically or cytologically confirmed unresectable or metastatic solid tumor that is refractory to standard therapy or for which in the opinion of the investigator no standard therapy is suitable. 2. Patient should have at least 1 measurable lesion per RECIST version 1.1 as assessed by the investigator. For Part A only, patients with radiographically evaluable but non-measurable disease are allowed after discussion with the sponsor. 3. Recovered from AEs (except irAEs) of prior chemotherapy (per NCI CTCAE version 5.0) to Grade ≤ 1 or return to baseline status (except for alopecia) as per Investigator's discretion. 4. The patient has an ECOG performance status of 0 to 2. 5. The patient has adequate bone marrow, renal, and hepatic function, defined as follows: 1. Hemoglobin ≥9.5 g/dL (without transfusion in the prior 3 weeks). 2. Platelets ≥100 × 109 cells/L (may be achieved with transfusion as per PI discretion) 3. ANC ≥1.5 ×109 ce
Where
- Scottsdale, Arizona
- Bakersfield, California
- El Segundo, California
- Santa Monica, California
- Stanford, California
- Portland, Oregon
- Dallas, Texas
Collaborators
CBCC Global Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 2, 2025 · Source of record for eligibility and locations