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AzTrials

Advanced Endometrial CarcinomaPhase 1NCT05039801

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Phase 1 study testing Bevacizumab, Glutaminase-1 Inhibitor IACS-6274 and Paclitaxel in people with Advanced Endometrial Carcinoma and Advanced Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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
Search all trials

Trial summary

To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Glutaminase-1 Inhibitor IACS-6274 and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
30 Sep 2021to 30 Jun 2028
Phase
Phase 1
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

  • Provision of written informed consent prior to any study related procedures and compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Male or female patients ≥18 years of age at the time of study entry who agree to participate by giving written informed consent prior to participation in any study related activities.
  • Histologically or cytologically confirmed advanced solid tumors, specifically:
  • Dose Escalation for Part A may include:
  • Patients with tumors harboring actionable KEAP1/NFE2L2/STK11/NF1 mutations Patients with low ASNS expression levels (HGSOC or endometrial cancer) Patients who had immunotherapy (IO) melanoma (Minimum treatment duration of prior PD-1 or PD-L1-containing regimen of 12 weeks [or equivalent of 2 response evaluations]).
  • Patients with post-platinum HNSCC Patients with chondrosarcoma Patients with ARID1A mutant clear cell ovarian cancer
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  • Dose Escalation for Part B may include:
  • Confirmed recurrent high-grade non-mucinous ovarian cancer that is platinum-resistant, defined as disease relapse within a platinum-free interval (PFI, or the time elapsed from the last date of platinum dose until PD) of < 6 months, and with less than 5 prior therapies
  • Dose Expansion for Part B limited to:
  • Confirmed recurrent high-grade non-mucinous ovarian cancer with low ASNS expression levels that is platinum-resistant, defined as disease relapse within a PFI of < 6 months, and with less than 5 prior therapies.
  • Dose Escalation for Part C may include:
  • Patients with tumors harboring actionable KEAP1/NFE2L2 mutations Patients with tumors harboring PIK3CA hotspot mutations, activating AKT mutations, and inactivating PTEN mutations (irrespective of KEAP1/NFE2L2 mutations) Patients with low ASNS expression levels (HGSOC)
  • Dose Expansion for Part C limited to:
  • Patients with NSCLC with actionable KEAP1/NFE2L2 mutations Patients with HGSOClow ASNS expression levels (irrespective of biomarker status for KEAP1/NFE2L2)
  • Patients must have received at least one line of therapy for advanced stage disease and be refractory or ineligible to available existing therapy(ies) known to provide clinical benefit for their condition.
  • Prior treatment with chemotherapy, radiotherapy, immunotherapy or any investigational therapies must have been completed at least 3 weeks or at least five half lives, whichever is shorter, before the study drug administration, and all AEs (excluding alopecia and peripheral neuropathy) have either returned to ≤Grade 1 or stabilized. Patients with concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) are allowed.
  • Fresh and/or archival tumor tissue from a biopsy obtained between the completion of the most recent line of treatment until study entry must be available for mutation and biomarker analysis. If available, archival tumor tissue from the time of initial diagnosis or the most recent biopsy (archival and/or fresh) will be collected. For ovarian cancer patients, a fresh biopsy must be collected in addition to archival tumor tissue. NOTE: No fresh tumor tissue will be required if a previous biopsy detected the selected mutations for each cohort. In all cases, procedures to obtain fresh tumor tissue should not put the patient at undue risk, and should only be performed if the risk is minimal (no greater than 2% risk of serious or severe complications).
  • Patients must have at least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessments.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
  • Adequate organ function as indicated by the following laboratory values:
  • Absolute neutrophil count (ANC) ≥1.0×109/L Platelets ≥100×109/L Hemoglobin ≥9.0 g/dL (>5.59 mmol/L) Creatinine clearance (CrCl) >50 mL/min. Actual body weight should be used for calculating creatinine clearance using the Cockroft Gault equation (except for patients with body mass index >30 kg/m2 when the lean body weight should be used, and without the need for chronic dialysis therapy).
  • Serum total bilirubin ≤1.5×ULN (with the exception of patients with known thalassemia minor mutations or Gilbert's syndrome: serum total bilirubin must be <3×ULN in these patients) Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) ≤2.5×ULN or ≤5×ULN for patients with liver metastases)
  • Adequate cardiac function with a left ventricular ejection fraction ≥50%
  • Female patients of non childbearing potential, who are physiologically incapable of becoming pregnant, are eligible to enter and participate in the study if they:
  • have had a hysterectomy, OR have had a bilateral oophorectomy, OR have had a bilateral salpingectomy, OR is postmenopausal (total cessation of menses for ≥2 years, or follicle stimulating hormone ≥50 IU/L).
  • Female patients of childbearing potential, who are not post-menopausal or surgically sterile and intent to be sexually active with a non-sterile male partner, are required to use one form of highly effective contraception combined with a barrier method (male condom, female condom, cervical cap, diaphragm with spermicide, or contraceptive sponge with spermicide) of contraception starting before entering the study and until 4 weeks after the last dose of treatment.
  • Highly effective non-hormonal contraceptive methods that are acceptable include:
  • Total/true abstinence for the total duration of the study treatment and for at least 1 month after the last dose of study treatment. Periodic abstinence using methods such as calendar ovulation, symptothermal, post ovulation methods, declaration of abstinence solely for the duration of a trial, or withdrawal are not acceptable methods of contraception.
  • Having a vasectomized sexual partner, who received post-vasectomy confirmation of azoospermia, combined with a barrier method as described above.
  • Bilateral tubal occlusion combined with a barrier method as described above. Intrauterine device with copper banded coils, combined with a barrier method as described above.
  • Highly effective hormonal contraceptive methods that are acceptable include:
  • Combined oral pill contraception (normal and low-dose oral pills, or progesterone-based oral pills using desogestrel) combined with a barrier method as described above. NOTE: cerazette is currently the only highly efficacious progesterone-based pill available.
  • Injection (e.g., medroxyprogesterone) combined with a barrier method as described above.
  • Patch (e.g., norelgestromin or ethinyl estradiol transdermal system) combined with a barrier method as described above.
  • Implants (etonorgestrel-releasing) combined with a barrier method as described above.
  • Intravaginal device (e.g., ethinyl estradiol- or etonogestrel-releasing) combined with a barrier method as described above.
  • Intrauterine system (levonorgestrel-releasing) combined with a barrier method as described above.
  • In addition to the to use one form of highly effective contraception combined with a barrier method, female patients of childbearing potential must have a negative serum pregnancy test at screening (within 7 days of the start of treatment) and must not be breastfeeding.
  • Non-sterile men, who are not sexually abstinent and intend to be sexually active with a woman of childbearing potential, must use a condom from the start of the trial and until 16 weeks after the last dose of treatment, or must practice total abstinence*** for the total duration of the study treatment and at least 3 months after the last dose of study treatment. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Female partners of childbearing potential should consider the use of at least one contraception method describe above. If the female partner is pregnant, male participants should use a condom plus spermicide.
  • Total/true abstinence is defined as a patient who refrains from any form of sexual intercourse, and this is in line with their usual and/or preferred lifestyle.

Who cannot join

  • Prior malignancy within the previous 2 years except for locally curable cancers that have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the cervix, breast or bladder.
  • Known primary central malignancy or symptomatic central nervous system metastasis(es).
  • Note: Patients with stable, previously treated brain metastases may participate if neurologic symptoms have resolved, patients have been off steroids (at least 7 days for Part A and Part B, and at least 4 weeks for Part C), and there is no evidence of disease progression by imaging for at least 2 weeks before the first dose of study treatment.
  • Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following cardiac conditions:
  • Any unstable cardiac arrhythmia within 6 months prior to enrolment
  • Prolongation of the Fridericia corrected QT (QTcF) interval defined as >450 ms for males and >470 ms for females
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  • History of any of the following cardiovascular conditions within 6 months of enrolment:
  • cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, class III or IV congestive heart failure, as defined by the New York Heart Association.
  • Major surgical intervention within 28 days before study drug administration, or an anticipated need for major surgery during the study.
  • Significant acute or chronic infections.
  • Any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • Treatment with strong cytochrome P450 subtype 3A4 (CYP3A4) inducers and inhibitors (including grapefruit juice) within 2 weeks of the first dose of study drug NOTE: patients must have stopped taking St. John's Wort 3 weeks prior to the start of treatment and stopped taking enzalutamide 4 weeks prior to the start of treatment.
  • Treatment with strong CYP450 subtype 2D6 (CYP2D6) inhibitors or sensitive CYP3A4 substrates within 7 days of the first dose of study drug.
  • Radiotherapy within 4 weeks prior to the start of study drug. Palliative radiotherapy for symptomatic control is acceptable if completed at least 2 weeks prior to study drug administration and no additional radiotherapy for the same lesion is planned.
  • Underlying medical conditions (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant and active bleeding diseases), for which in the investigator's opinion will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or AEs.
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to any of the compounds in the study.
  • Known history of alcohol or drug abuse.
  • Legal incapacity or limited legal capacity.
  • Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses (such as refractory nausea and vomiting, chronic gastrointestinal disease or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretionof IACS-6274 and capivasertib, which are oral agents.
  • Patients unwilling to comply with protocol requirements related to the assigned part.
  • Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
  • Part B Specific Exclusion Criteria (B1) Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (that is, three or more features of partially controlled asthma).
  • (B2) Patient has a known hypersensitivity to paclitaxel or bevacizumab components or excipients.
  • (B3) Patient has a history of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
  • (B4) Patient has proteinuria as demonstrated by urine protein:creatinine ratio ≥1.0 at screening or urine dipstick for proteinuria ≥2 (patients discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate <2 g of protein in 24 hours to be eligible).
  • (B5) Patient is at increased bleeding risk due to concurrent conditions (e.g., major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
  • (B6) Patient has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident [CVA]) within 6 months of enrollment. (B7) Patient has pre-existing peripheral neuropathy that is Grade ≥2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria.
  • (B8) Patient requires paracentesis 2 weeks prior to trial enrolment. Part C Specific Exclusion Criteria (C1) History of another primary malignancy, except for a malignancy treated with curative intent, with no known active disease ≥5 years before the first dose of treatment, with low potential risk for recurrence. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy.
  • (C2) Patient has a known hypersensitivity to capivasertib components or any excipients of the product.
  • (C3) Clinically significant abnormalities of glucose metabolism as defined by any of the following: Diagnosis of diabetes mellitus type I or II (irrespective of management), Glycosylated haemoglobin (HbA1c) >8% (64 mmol/mol) (C4) Patients with evidence of severe or uncontrolled systemic liver disease including severe hepatic impairment, or abnormal liver enzymes at screening (AST or ALT >2.5 x ULN; total bilirubin >1.5 x ULN).
  • (C5) Patients with elevated alkaline phosphatase (ALP) can be enrolled if the abnormal value is due to the presence of bone metastasis, but liver function is considered adequate according to the principal investigator.
  • (C6) Patients with persistent toxicities (Grade ≥2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment may be included after consultation with the sponsor and the study physician.
  • (C7) Patients with spinal cord compression or leptomeningeal disease not requiring steroids for at least 4 weeks prior to start of study intervention.
  • (C8) Patients with clinically significant cardiovascular disease including, but not limited to, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident [CVA]) within 6 months of enrollment. In addition, patients will be excluded based on the study physician's judgment of the following criteria:
  • Mean resting corrected QT interval >470ms, obtained from triplicate ECGs performed at screening.
  • Medical history significant for arrhythmia that is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation regardless of treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be included based on the study physician's judgment.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia of Grade ≥1, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first-degree relative, history of QT prolongation associated with other medications that required discontinuation of the medication.
  • Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association Grade ≥2.
  • Uncontrolled hypotension: SBP <90 mmHg and/or DBP <50 mmHg.
  • Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive).
  • (C9) Patients with active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) are excluded.
  • (C10) Patients with active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening are excluded.
  • Human immunodeficiency virus (HIV) positive patients with a viral load > 400 copies/mL and a CD4+ T-cell count of <350 cells/uL or with a history of an acquired immunodeficiency syndrome (AIDS) opportunistic infection within the past 12 months are excluded. Patients with a higher viral load or lower CD4+ count (< 350 cells/uL) may be considered for eligibility if the patient has a potentially curable malignancy or for interventions in a later stage of development that have demonstrated prior activity with a given cancer.
  • HIV-positive patients receiving antiretroviral therapies should be on established ART for at least four weeks before starting treatment to ensure that treatment is tolerated and that toxicities are not confused with investigational drug toxicities. HIV-positive patients receiving antiretroviral therapies that are strong CYP3A4/5 inhibitors/ inducers or sensitive substrates of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib.
  • (C12) Patients who are undergoing any concurrent anticancer treatment or any concomitant medication that may interfere with the study drugs according to local clinical guidelines are excluded.
  • (C13) Patients who received palliative radiotherapy within 2 weeks prior to the start of study treatment; or radiotherapy to more than 30% of the bone marrow within 4 weeks before the start of study treatment are excluded.

Trial locations and contacts

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

Timothy A Yap, MD contact

713-563-1930

tyap@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Timothy A. Yap, MD, 713-563-1930, tyap@mdanderson.org

    Timothy A. Yap, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1 Open-Label, Dose-Escalation and Dose-Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-Tumor Activity of IACS-6274 as Monotherapy and in Combination in Patients With Advanced Solid Tumors

To find the highest tolerable dose of IACS-6274 that can be given alone, in combination with bevacizumab and paclitaxel, or in combination with capivasertib to patients who have solid tumors. The safety and tolerability of the study drug(s) will also be studied.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the safety and tolerability of oral glutaminase inhibitor IPN60090 (IACS-6274) as monotherapy (Part A) and in combination therapy with bevacizumab and weekly paclitaxel (Part B) and in combination with capivasertib (Part C)

II. To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IACS-6274 in combination with bevacizumab and weekly paclitaxel (Part B). and of the combination of IACS-6274 and capivasertib (Part C). (For Dose Escalation Only)

SECONDARY OBJECTIVES:

  1. To assess the preliminary antitumor activity of IACS-6274 as monotherapy (Part A) in patients with or without biomarker selected tumor types.

II. To assess the preliminary antitumor activity of IACS-6274 in the combination with bevacizumab and weekly paclitaxel (Part B) in patients with recurrent platinum-resistant ovarian cancer and in combination with capivasertib (Part C) for all solid tumors.

III. To characterize the pharmacokinetics (PK) profile of IACS-6274 as a monotherapy (Part A) and in combination with bevacizumab and weekly paclitaxel (Part B) in the combination with capivasertib (Part C). To evaluate biomarkers of patient stratification and correlate them with clinical outcome.

EXPLORATORY OBJECTIVE:

  1. To collect biobank samples for potential future analysis of biomarkers (optional, informed consent required).

OUTLINE: This is a dose-escalation study of IACS-6274 followed by a dose-expansion study. Patients are assigned to 1 of 2 parts.

PART A: Patients receive IACS-6274 orally (PO) throughout the study.

PART B: Patients receive IACS-6274 PO, paclitaxel intravenously (IV), and bevacizumab IV throughout the study.

PART C: Patients receive IACS-627 PO, with capivasertib PO throughout the study.

Being tested
Bevacizumab, Glutaminase-1 Inhibitor IACS-6274, Paclitaxel, Capivasertib
Medical subject headings
Chondrosarcoma, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck, Melanoma, Ovarian Neoplasms

What participants receive

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

  • BevacizumabBiological

    Also called ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04

    Given IV

  • Glutaminase-1 Inhibitor IACS-6274Drug

    Also called GLS1 Inhibitor IACS-6274, IACS 6274, IACS-6274, IACS6274

    Given by PO

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given by IV (vein)

  • CapivasertibDrug

    Also called AZD5363

    Given by PO

Study groups in NCT05039801
Study groupRoleWhat they receive
Part A (IACS-6274)ExperimentalPatients receive IACS-6274 PO throughout the study.
Receives: Drug: Glutaminase-1 Inhibitor IACS-6274
Part B (IACS-6274, bevacizumab, paclitaxel)ExperimentalPatients receive IACS-6274 PO, paclitaxel IV, and bevacizumab IV throughout the study.
Receives: Biological: Bevacizumab; Drug: Glutaminase-1 Inhibitor IACS-6274; Drug: Paclitaxel
PART C: (IACS-6274) with capivasertibExperimentalPatients receive IACS-627 PO, with capivasertib PO throughout the study.
Receives: Drug: Glutaminase-1 Inhibitor IACS-6274; Drug: Capivasertib

What is being measured

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

  1. Incidence of adverse events (AEs)

    Will be assessed by the rate of dose limiting toxicities at each dose level in the dose escalation, and the rate of AEs and the rate of Grade 3 and higher AEs in the dose escalation and dose expansion. All AEs will be coded according to the latest version of Medical Dictionary for Regulatory Activities and National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 90 days

Timeline

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

  1. First posted10 Sep 2021
  2. Study start30 Sep 2021
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Jun 2028 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039801
Sponsor's protocol ID
2021-0265
Other IDs
NCI-2021-09063, 2021-0265
Status last verified
Oct 2026
First submitted
1 Sep 2021
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bevacizumab, Glutaminase-1 Inhibitor IACS-6274 and Paclitaxel in people with Advanced Endometrial Carcinoma and Advanced Head and Neck Squamous Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site 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 40 inclusion and 46 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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 Timothy A Yap, MD (713-563-1930, tyap@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 90 days). 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 NCT05039801.

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 6 Oct 2026.

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