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Solid TumorPhase 1/2NCT06234098

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

A Phase 1/2 study testing AT-1965 Liposome Injection in people with Solid Tumor, run by Alyssum Therapeutics at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
AT-1965 Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
9 sitesUnited States
Study dates
13 Feb 2024to Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • NOTE: For the backfill cohort, patient must have a histologically or cytologically confirmed unresectable or metastatic solid tumor and have received at least three prior treatments. Enrollment of patients in the backfill cohort will occur after receiving the sponsor's approval.
  • 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.
  • 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.
  • The patient has an ECOG performance status of 0 to 2.
  • The patient has adequate bone marrow, renal, and hepatic function, defined as follows:
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  • Hemoglobin ≥9.5 g/dL (without transfusion in the prior 3 weeks).
  • Platelets ≥100 × 109 cells/L (may be achieved with transfusion as per PI discretion)
  • ANC ≥1.5 ×109 cells/L
  • Creatinine Clearance ≥60 mL/min (by using Cockcroft-gault equation)
  • Total bilirubin ≤1.5 × ULN, unless the patient has a prior history of Gilbert's syndrome, in which case ≤3.0 × ULN is acceptable.
  • AST and ALT ≤2.5 × ULN; or ≤5 × ULN if due to liver involvement by tumor
  • Female patients of child-bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test before each start of a new treatment cycle.
  • NOTE: Women are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause) and have an elevated follicle-stimulating hormone (FSH) at screening.
  • Female patients of childbearing potential must agree to use a highly effective method of contraception during the study and for a minimum of 3 months following administration of study drug, which includes a barrier method plus 1 or more of the following:
  • Hormonal contraceptives (e.g., birth control pills, skin patches, vaginal rings, or the Depo-Provera® shot)
  • Intrauterine device (IUD)
  • Male or female condoms with spermicide
  • Diaphragm with spermicide
  • Permanent tubal occlusive birth control system
  • Male patients with female partners of childbearing potential must be vasectomized or be willing to use an acceptable method of birth control or to practice abstinence during the study and for 3 months after the last dose of IMP.
  • Must be 28 days since mRNA Covid 19 vaccine injection.
  • Willing to avoid sun exposure, wear protective clothing, and/or apply broad spectrum (ultraviolet A [UVA] and ultraviolet B [UVB] protection) sunscreen if sun exposure is unavoidable.
  • The patient is capable of understanding the written informed consent, provides signed and witnessed written informed consent and authorization permitting use of collected tissue and personal health information, and agrees to comply with protocol requirements.
  • For Part B Dose Expansion in TNBC only:
  • Histologically or cytologically confirmed metastatic triple-negative breast cancer (mTNBC) who had received at least two prior treatments (a taxane and sacituzumab govitecan-hziy) for metastatic disease, for advanced disease.
  • In addition, patients with TNBC with either Low HER2 (IHC 1+ or IHC 2+/in situ hybridization-negative), PD-L1 (CPS>10) or BRCA mutation need to have prior FDA approved available therapies before participation in this expansion arm.

Who cannot join

  • The patient has an uncontrolled or life-threatening, symptomatic, current or recurrent disease (e.g., cardiovascular, renal, hepatic, endocrine) or other abnormality that could affect the action, absorption, or disposition of the study drug, may impact the ability of the patient to participate, may affect clinical or laboratory assessments, or otherwise has the potential to confound the study results.
  • Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition) or any important medical or psychiatric illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
  • Uncontrolled diabetes.
  • Patients with an active uncontrolled autoimmune disease. Excluded autoimmune conditions are listed in the Protocol Appendix 1.
  • Patients with history of transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent are not excluded (e.g. acute Lyme arthritis).
  • Please contact the medical monitor regarding any uncertainty over autoimmune exclusions.
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  • History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on chest computed tomography scan in the last 6 months; NOTE: history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • History of hemolysis or hemolytic anemia.
  • Evidence of ongoing subclinical hemolysis (high LDH and low serum haptoglobin with increased reticulocyte count).
  • History of adrenal gland disorders such as Cushing Syndrome, Congenital adrenal hyperplasia, Addison's Disease and hyperaldosteronism
  • Recipient of an allogeneic bone marrow transplantation or solid organ transplantation.
  • Endocrinopathy, unless on stable hormone replacement therapy.
  • History of known human immunodeficiency virus (HIV); unresolved viral hepatitis as documented by the detection of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody at the time of the screening visit, and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
  • Clinically significant cardiovascular disease including:
  • 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.
  • 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.
  • 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.
  • 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).
  • 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
  • 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
  • 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.
  • History of severe immune-related AE (irAE) that led to permanent discontinuation of prior immunotherapy.
  • 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.
  • Has, within 28 days prior to screening, received a live, attenuated or mRNA based vaccine against infectious disease.
  • Nursing women not willing to stop breastfeeding while on study and for 3 months thereafter.
  • 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.
  • Patient is <18 years of age at the time of informed consent.
  • Life expectancy of <3 months.
  • Known current drug or alcohol abuse.
  • The patient is not an appropriate candidate for participation in this clinical study for any other reason as deemed by the investigator.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Britney Barrera contact

661-376-0047

britney.barrera@cbcc.global

Eldho Jose contact

+91 9095326268

eldho.jose@cbcc.global

9 sites in 1 country

United States9 sites, 8 recruiting

  • CBCC Global Research Site 005

    Bakersfield, California, 93309

    Withdrawn

  • CBCC Global Research Site 006

    Dallas, Texas, 75230

    Recruiting

  • CBCC Global Research Site 007

    El Segundo, California, 90245

    Recruiting

  • CBCC Global Research Site 010

    New York, New York, 10065

    Not yet recruiting

  • CBCC Global Research Site 002

    Portland, Oregon, 97239

    Recruiting

  • CBCC Global Research Site 008

    Santa Monica, California, 90403

    Recruiting

  • CBCC Global Research Site 009

    Santa Monica, California, 90404

    Recruiting

  • CBCC Global Research Site 001

    Scottsdale, Arizona, 85258

    Recruiting

  • CBCC Global Research Site 003

    Stanford, California, 94305

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors

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.

Conditions
Solid Tumor
Being tested
AT-1965 Liposome Injection
Keywords
Advanced Solid Tumors, Refractory Solid Tumors, Recurrent Solid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AT-1965 Liposome InjectionDrug

    AT-1965 Liposome Injection administered intravenously once weekly for the first 3 weeks (Days 1, 8 and 15) of a 4 week cycle.

Study groups in NCT06234098
Study groupRoleWhat they receive
AT-1965 Liposome InjectionExperimentalNot described
Receives: Drug: AT-1965 Liposome Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Nature and frequency of dose-limiting toxicities (DLTs) associated with AT-1965 administration, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

    Measured: Dose limiting toxicities will be evaluated during the first treatment cycle (28 days)

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

    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

    Measured: 3, 6 and 9 month

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

    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.

    Measured: 3, 6 and 9 month

Secondary outcomes (19)

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

    Pharmacokinetic profile of AT-1965 measured by AUC(0-t)

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  2. Area under the concentration-time curve from zero to 168 hours [AUC(0-168)]

    Pharmacokinetic profile of AT-1965 measured by AUC(0-168)

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  3. Area under the concentration-time curve from zero to 24 hours

    Pharmacokinetic profile of AT-1965 measured by AUC(0-24)

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

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

    Pharmacokinetic profile of AT-1965 measured by AUC(0-inf)

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  5. Maximum plasma concentration [Cmax]

    Pharmacokinetic profile of AT-1965 measured by Cmax

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  6. Minimum plasma concentration [Cmin]

    Pharmacokinetic profile of AT-1965 measured by Cmin

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  7. Time to maximum plasma concentration [tmax]

    Pharmacokinetic profile of AT-1965 measured by tmax

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  8. Elimination half-life [t1/2]

    Pharmacokinetic profile of AT-1965 measured by t1/2

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  9. Volume of distribution [Vz/F]

    Pharmacokinetic profile of AT-1965 measured by Vz/F

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  10. Clearance (CL/F)

    Pharmacokinetic profile of AT-1965 measured by CL/F

    Measured: Days 1, 8, and 15 of each treatment cycle (duration of each treatment cycle will be 28 days in both parts of the study)

  11. The number of Adverse Events (AE) that occurs

    All AEs will be graded according to CTCAE version 5.0 Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences Grade 5: Death related to AE

    Measured: Adverse events will be recorded from informed consent through 30 days after the last dose of study drug

  12. Laboratory Parameters

    Incidence of clinically significant clinical laboratory abnormalities (hematology, clinical chemistry, coagulation, and urinalysis)

    Measured: Screening, Days 1, 8, and 15 of each treatment cycle (each cycle is 28 days)

  13. The number of Serious Adverse Events (SAE) that occurs

    Measured: SAEs will be recorded from the start of the first dose of AT-1965 (Cycle 1 Day 1) up to 30 days after the last dose of study drug or until resolution or stabilization of SAEs

  14. Clinical Benefit Ratio (CBR) based on RECISTv1.1 and iRECIST

    Clinical Benefit Rate (CBR) defined as the percentage of patients who have achieved complete response, partial response and stable disease according to RECISTv1.1 and iRECIST as assessed by the Investigator.

    Measured: 3, 6 and 9 month

  15. Duration of Clinical Benefit (DoCB) based on RECISTv1.1 and iRECIST

    Duration of Clinical Benefit (DoCB) defined as the time from randomization to disease progression in patients who achieve complete response, partial response, or stable disease according to RECISTv1.1 and iRECIST as assessed by the Investigator.

    Measured: 3, 6 and 9 month

  16. Progression-free survival (PFS) based on RECIST version 1.1

    Progression-free survival (PFS), defined as the time from first dose to confirmed progression of disease (PD) or death, according to RECIST v1.1 as assessed by the Investigator.

    Measured: 3, 6 and 9 month

  17. Best Overall Response (BOR) based on RECISTv1.1 and iRECIST

    Best Overall response (BOR) defined as the best response across all time points (for example, a patient who has SD at first assessment, PR at second assessment, and PD on last assessment has a best overall response of PR) according to RECISTv1.1 and iRECIST as assessed by the Investigator.

    Measured: 3, 6 and 9 month

  18. Overall Survival (OS) based on RECISTv1.1 and iRECIST

    Overall Survival (OS) is defined as the time from the date of first dose of study treatment to the date of death due to any cause.

    Measured: 3, 6 and 9 month

  19. Time to next treatment (TTNT)

    Time to next treatment (TTNT), defined as the time from start date of AT-1965 to start date of the next line of anti-cancer therapy.

    Measured: 3, 6 and 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start13 Feb 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06234098
Sponsor's protocol ID
AT-1965-101
Status last verified
Jul 2026
First submitted
18 Jan 2024
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AT-1965 Liposome Injection in people with Solid Tumor, run by Alyssum Therapeutics at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Britney Barrera (661-376-0047, britney.barrera@cbcc.global), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06234098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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