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Study of AT-1965 for Advanced Solid Tumors

This study is testing a new treatment called AT-1965 Liposome Injection for people with advanced, refractory (not responding to standard treatment), or recurrent (coming back) solid tumors. Researchers want to understand its safety, how your body handles it (pharmacokinetics), its effects on the body (pharmacodynamics), and if it shows early signs of shrinking tumors. You might be able to join if you have an unresectable (can't be removed by surgery) or metastatic (spread to other parts of the body) solid tumor that hasn't responded to other treatments or for which standard treatments aren't suitable. The study will look for how well the tumor responds to treatment (Objective Response Rate) and how long that response lasts (Duration of Response). The current status of the study is unclear.

Study design
This is a first-in-human, open-label study, meaning both you and the study team will know you are receiving AT-1965. It aims to enroll 100 participants in total.
What's involved
You would receive AT-1965 Liposome Injection intravenously (into a vein) once a week for the first three weeks of a four-week cycle.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate your tumor response at 3, 6, and 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06234098

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Alyssum Therapeutics
~100 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:AT-1965 Liposome Injection

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicity (DLT) according to CTCAE version 5.0 in Part A - Dose Escalation Phase
Measured over Dose limiting toxicities will be evaluated during the first treatment cycle (28 days)
+2 more outcomes measured

Conditions

Solid Tumor

Explore related trials

Breast CarcinomaSolid Neoplasm

Where it's being run

9 sites across 5 states
California5
Arizona1
New York1
Oregon1
Texas1

Study leadership

  • Richard Fahrner, PhD · STUDY_DIRECTOR · Alyssum Therapeutics

Who to contact

Britney Barrera
[email protected]
661-376-0047
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

Myocardial infarction or stroke within 6 months prior to the initiation of study treatment.
LVEF \<50% on baseline assessment.
If patient enrolled with cardiovascular disease, the LVEF must be confirmed at screening by and echocardiogram or MUGA.
Unstable angina within 6 months prior to the initiation of study treatment.
Congestive heart failure or cardiomyopathy with New York Heart Association Class 2, 3 or 4 by clinical assessment or by imaging studies within 6 months prior to the initiation of study treatment.
Coronary or peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism (in past 3 months).
History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
Uncontrolled hypertension where the Systolic is ≥150 mmHg and the diastolic blood pressure ≥110 mm Hg despite ongoing antihypertensive therapy.
QT interval corrected by the Fridericia correction formula (QTcF) ≥470 msec on the Screening ECG.
The patient requires the use of concomitant medications that prolong QT/QTc interval (except the patients who have normal ECG but are taking medications that prolong QT/QTc interval) unless approved by medical monitor. 13. Recent anticancer treatment, including the following (patient may be started earlier within these timeframes if considered by the Investigator to be safe and within the best interest of the patient and with approval from the Sponsor):
Systemic antineoplastic therapy within 21 days or 5 half-lives prior to initiation of study treatment. (6 weeks for nitrosoureas or mitomycin C and 8 weeks for platinum based drugs) and/or has not recovered from acute toxicity for the most recent antitumor treatment to CTCAE Grade 1 or baseline, except for alopecia, prior to the first dose of study drug, whichever is shorter. (6 weeks for nitrosoureas or mitomycin C and 8 weeks for platinum-based drugs) and/or has not recovered from acute toxicity for the most recent antitumor treatment to CTCAE Grade 1 or baseline, except for alopecia, prior to the first dose of study drug.
Radiation therapy within 2 weeks prior to the initiation of study treatment
Patient received chemoembolization or radioembolization within 4 weeks prior to the initiation of study treatment. 14. The patient has received any investigational agents that have not received regulatory approval within 30 days or 5 half-lives prior to the first dose of study drug, whichever is shorter. This includes the FDA approved for all Emergency Authorization Use (EAU) drugs or therapies. 15. Major surgery within 4 weeks of starting study treatment or not recovered from any effects of prior major surgery (uncomplicated central line placement or fine needle aspirate are not considered major surgery). 16. Primary tumor type:
Central nervous system (CNS) malignant disease not previously treated, active leptomeningeal disease, uncontrolled symptomatic CNS involvement, or CNS malignant disease requiring steroid or other therapeutic intervention.
Liquid/hematological tumors
Lymphoma
Uveal melanoma 17. Patients with a history of secondary malignancy(ies) that is currently clinically significant and has potential for metastases or currently requires active intervention (except for gonadotropin-releasing hormone (GnRH) or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or hormonal therapy in breast cancer).
Secondary malignancies exceptions include basal cell or squamous cell skin cancer 18. Requires systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to Day 1 of treatment. Inhaled, intranasal, intra-articular and topical (including ocular) steroids are allowed. Adrenal replacement (i.e., physiologic replacement) doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 19. History of severe immune-related AE (irAE) that led to permanent discontinuation of prior immunotherapy. 20. History of Grade ≥ 3 irAE within the past 16 weeks or any Grade 4 life threatening irAE (regardless of duration) or neurologic or ocular AE of any grade while receiving prior immunotherapy; NOTE: Patients with endocrine AEs of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy but must have no history of adrenal crisis and be asymptomatic. 21. Has, within 28 days prior to screening, received a live, attenuated or mRNA based vaccine against infectious disease. 22. Nursing women not willing to stop breastfeeding while on study and for 3 months thereafter. 23. Uncontrolled active infection requiring intravenous (IV) antibiotic, antiviral, or antifungal medications within 14 days prior to first dose of study treatment. Patients on chronic suppressive antibiotics may be allowed after discussion with the Sponsor. 24. Patient is \<18 years of age at the time of informed consent. 25. Life expectancy of \<3 months. 26. Known current drug or alcohol abuse. 27. The patient is not an appropriate candidate for participation in this clinical study for any other reason as deemed by the investigator.

What this trial measures

  • Dose Limiting Toxicity (DLT) according to CTCAE version 5.0 in Part A - Dose Escalation PhaseDose 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 Phase3, 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 Phase3, 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.