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Uterine Endometrial CancerPhase 1/2NAPISTAR 1-03NCT07743541

Study of TUB-040 in Patients With Recurrent or Progressive Uterine Cancer After Chemotherapy and Immune Therapy

A Phase 1/2 study testing TUB-040 - Dose escalation and TUB-040 - RP2D in people with Uterine Endometrial Cancer, run by Gilead Sciences at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with recurrent or progressive uterine endometrial cancer after platinum-based chemotherapy and immune checkpoint inhibitor therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Uterine Endometrial Cancer
What is being tested?
TUB-040 - Dose escalation and TUB-040 - RP2D
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesUnited States
Study dates
Oct 2026to Sep 2029
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed advanced recurrent or progressive serous or endometroid endometrial cancer.
  • Note: Mixed histologies are allowed if the dominant subtype is serous or endometroid.
  • Pathological report with results of institutional MMR and/or MSI testing.
  • Received at least 1 but no more than 3 prior lines of anticancer therapy:
  • Must have received at least 1 line of platinum-based therapy and 1 line of programmed death ligand-1 (PD-L1) or programmed death-1 (PD-1) inhibitor therapy (separately or in combination) Note: Induction plus maintenance is considered as 1 line of therapy. Hormonal therapy without chemotherapy will not be considered a separate line of therapy
  • For dose escalation cohorts only:
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  • The requirement for prior treatment with a PD-1 or PD-L1 inhibitor is waived for patients enrolled in countries where treatment with these agents does not have regulatory approval for first line treatment after discussion with and approval from the Sponsor's medical monitor.
  • Radiographic progression on or after the most recent line of anticancer therapy.
  • Female aged ≥ 18 years at the time of consent.
  • Disease not amenable to curative intent treatment.
  • Radiologically measurable disease by RECIST v1.1, which can include a lesion in an irradiated field that showed progression by RECIST v1.1 after irradiation.
  • ECOG performance status of 0 or 1.
  • Life expectancy > 12 weeks for disease-related mortality as evaluated by the INV.
  • Willing to sign an archival tissue release form for research purposes and determination of biomarker (eg, NaPi2b) expression. An adequate tumor tissue sample, either a formalin-fixed, paraffin-embedded (FFPE) tissue block or a minimum of 6 freshly cut, unstained sections of the most recently available tumor sample, is mandatory for biomarker assessment by the central pathology laboratory. If no archival specimens are available, a newly acquired biopsy specimen must be provided
  • Willing to undergo a noncontrast high-resolution computed tomography (HRCT) scan of the thorax and pulmonary function testing at screening.
  • Adequate organ function as defined by all of the following criteria (parameters must be met without growth factor or transfusion support within 4 weeks prior to enrollment):
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase and alanine aminotransferase (ALT)/serum glutamic pyruvate transaminase ≤ 3.0 × the upper limit of normal (ULN)
  • Total serum bilirubin ≤ 1.5 × ULN (CTCAE Grade ≤ 1) unless secondary to Gilbert's syndrome. Patients with Gilbert's syndrome may be included if their unconjugated bilirubin is ≤ 3 × ULN.
  • Estimated glomerular filtration rate (eGFR) > 50 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration formula (Appendix B)
  • Alkaline phosphatase (ALP) < 2.5 × ULN, except if there is an alternative explanation for ALP elevation other than hepatic failure, such as the presence of bone metastasis
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1500/mm3
  • Platelet count ≥ 100,000/mm3
  • International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN in the absence of anticoagulation therapy. If patients are on anticoagulation therapy, INR should be within the therapeutic range for the medical indication
  • Resolution of all AEs from prior therapy or surgical procedures to Grade ≤ 1 or to baseline (exceptions included alopecia, hyperpigmentation or discoloration of the skin and nails [including vitiligo], stable immune-related toxicity such as hypothyroidism for patients on hormone replacement or corticosteroid treatment with prednisone, or equivalent, of ≤ 10 mg daily, and Grade 2 peripheral sensory neuropathy after prior treatment with taxane or other anticancer therapy).
  • Women of childbearing potential (WOCP) must have a negative serum pregnancy test during screening and be neither breastfeeding or intending to become pregnant during study participation. A female will be considered to be of childbearing potential following menarche unless they have undergone permanent sterilization (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or are postmenopausal. Postmenopausal is defined as at least 12 months without menses with no other medical reason (eg, chemical menopause due to anticancer treatment).
  • For WOCP, agreement must be provided to use a medically approved, highly effective contraceptive method from the time of screening throughout the study and for 6 months after the last administration of study treatment.
  • Ability to understand, give written informed consent, comply with all study-related procedures, medication use, and assessments.
  • No history of noncompliance with medical regimens or considered, in the opinion of the INV, to be potentially unreliable and/or uncooperative.
  • Willing to sign and date the ICF

Who cannot join

  • Unresolved bowel obstruction, including radiographic findings consistent with bowel obstruction plus clinical signs and symptoms of obstruction such as nausea and/or vomiting.
  • Prior thoracocentesis for therapeutic drainage of malignant effusion within 4 weeks prior to initiation of study treatment.
  • Paracentesis for therapeutic drainage of malignant effusion within 4 weeks prior to initiation of study treatment.
  • Receiving total parenteral nutrition.
  • Serum albumin < 2.5 g/dL (patients should not receive IV albumin within 4 weeks prior to testing).
  • Known active central nervous system metastases and/or carcinomatous meningitis. Note: Previously treated brain metastases allowed if follow-up brain imaging after CNS directed therapy shows no evidence of progression, and they have been off steroids for > 4 weeks prior to first dose.
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  • Pregnant, lactating, or breastfeeding.
  • History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.
  • Prior treatment with an ADC-containing Topo-1 inhibitor payload. ADCs with other payloads are allowed (eg, monomethyl auristatin E, monomethyl auristatin F).
  • Discontinuation of the most recent systemic anticancer therapy due to hematologic toxicity.
  • Participation in any interventional clinical studies either concurrently or within 28 days or 5 half-lives (whichever is shorter) prior to enrollment of any investigational pharmacologic agent, imaging materials, including dyes, investigational surgical techniques, or devices.
  • Chemotherapy or other anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to initiation of study treatment.
  • Radiotherapy < 2 weeks prior to enrollment. Patients with wide-field radiotherapy (> 30% of marrow-bearing bone) must not have had treatment within 4 weeks prior to initiation of study treatment.
  • Major surgery within 21 days prior to signing ICF unless the patient has recovered at that time.
  • Note: Major surgery involves opening of a body cavity such as the thorax or abdomen. A lymph node or skin biopsy is not considered major surgery. Minor surgical procedures such as central venous catheter placement, tumor biopsy, and feeding tube placement are not considered major.
  • Active ILD/pneumonitis or history of noninfectious ILD/pneumonitis/radiation pneumonitis that required steroid treatment.
  • Oxygen saturation of < 93% on room air at rest
  • Resting QTcF > 470 msec. If a single QTcF is > 470 msec, the patient may enroll if the mean QTcF from 3 electrocardiograms (ECGs) is < 470 msec.
  • History of nephrotic syndrome or proteinuria Grade ≥ 2.
  • Active corneal disease, or history of corneal disease within 4 months prior to enrollment.
  • Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, respiratory, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the INV, would predispose the patient to the development of complications from the administration of protocol therapy.
  • History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.
  • Documented other concurrent nonmalignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (New York Heart Association III or IV).
  • Any concurrent anticancer chemotherapy, radiotherapy (palliative radiation may be permitted after approval by the sponsor in accordance with protocol), hormonal therapy, immunotherapy, corticosteroid therapy other than that permitted in protocol), or any other prohibited medications as listed in protocol.
  • Live vaccines within 30 days prior to study enrollment.
  • Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4.
  • For Phase 1 only: Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure with reduced ejection fraction or severe diastolic dysfunction, potential for torsades de pointes, congenital long QT syndrome.
  • Positive for hepatitis B surface antigen (HbsAg) or hepatitis B (HBV) DNA.
  • Active acute or chronic infection.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

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

Tubulis Clinical Trial Inquiries contact

+49 175 800 5594

ct-inquiries@tubulis.com

United States4 sites

  • START New Jersey

    East Brunswick, New Jersey, 08816

  • START New York-Long Island

    Lake Success, New York, 11042

  • START Los Angeles

    Los Angeles, California, 90025

  • START Mountain Region, LLC

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: A Multicenter Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the NaPi2B Antibody-Drug Conjugate TUB-040 in Patients With Recurrent or Progressive Uterine Endometrial Cancer After Platinum-Based Chemotherapy and Immune Checkpoint Inhibitor Therapy

The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with recurrent or progressive uterine endometrial cancer after platinum-based chemotherapy and immune checkpoint inhibitor therapy.

The primary objectives of Phase 1 of this study are to determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).

The primary objective of Phase 2 of this study is to evaluate the efficacy of TUB-040 monotherapy at the RP2D in endometrial cancer.

Being tested
TUB-040 - Dose escalation, TUB-040 - RP2D
Keywords
Recurrent Endometrial Cancer, Progressive Endometrial Cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • TUB-040 - Dose escalationDrug

    TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle.

  • TUB-040 - RP2DDrug

    TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle. Dose based on the RP2D

Study groups in NCT07743541
Study groupRoleWhat they receive
Phase 1: Dose Escalation of TUB-040ExperimentalParticipants will receive escalating doses of TUB-040 to determine recommended Phase 2 dose (RP2D).
Receives: Drug: TUB-040 - Dose escalation
Phase 2: Monotherapy of TUB-040ExperimentalParticipants in Phase 2 will receive the recommended dose of TUB-040 monotherapy determined in Phase
Receives: Drug: TUB-040 - RP2D

What is being measured

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

  1. Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: Up to 3 years

  2. Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)

    Incidence of dose-limiting toxicities (DLTs) at each dose level

    Measured: Up to 3 years

  3. Phase 2: Overall Response Rate (ORR)

    Investigator (INV) assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

Secondary outcomes (16)

  1. Phase 1: Overall Response Rate (ORR)

    Investigator (INV) assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  2. Phase 1: Duration of Response (DOR)

    Investigator (INV) assessment of duration of response (DOR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  3. Phase 1: Progression-Free Survival (PFS)

    Investigator (INV) assessment of progression-free survival (PFS) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  4. Phase 1: Disease Control Rate (DCR)

    Investigator (INV) assessment of disease control rate (DCR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  5. Phase 1: Overall Survival (OS)

    Overall Survival (OS)

    Measured: Up to 3 years

  6. Phase 1: Change From Baseline in Fridericia's Corrected QT interval (QTcF)

    Change from baseline in QTcF

    Measured: Up to 3 years

  7. Phase 1: Pharmacokinetic (PK) parameter: Cmax

    Cmax is defined as: Maximum plasma/serum concentration (Cmax)

    Measured: Up to 3 years

  8. Phase 1: Pharmacokinetic (PK) parameter: Tmax

    Tmax is defined as: Time to Cmax

    Measured: Up to 3 years

  9. Phase 1: Pharmacokinetic (PK) parameter: AUC

    AUC is defined as: Area under the concentration time curve (AUC)

    Measured: Up to 3 years

  10. Phase 1: Pharmacokinetic (PK) parameter: t1/2

    t1/2 is defined as: If data collected allows estimated half-life

    Measured: Up to 3 years

  11. Phase1/Phase2: Percentage of Participants Who Develop Anti-TUB-040 Antibodies as appropriate

    Number and percentage of patients who develop anti-TUB-040 antibodies and a semiquantitative assessment of titer

    Measured: Up to 3 years

  12. Phase 2: Durability of Response (DOR)

    Investigator (INV) assessment of durability of response (DOR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  13. Phase 2: Progression-Free Survival (PFS)

    Investigator (INV) assessment of progression-free survival (PFS) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  14. Phase 2: Disease Control Rate (DCR)

    Investigator (INV) assessment of disease control rate (DCR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1

    Measured: Up to 3 years

  15. Phase 2: Overall Survival (OS)

    Overall Survival (OS)

    Measured: Up to 3 years

  16. Phase 2: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Incidence and severity of treatment emergent adverse events (TEAEs)

    Measured: Up to 3 years

Timeline

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

  1. First posted4 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionSep 2029 (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
Non-randomised
Intervention model
Sequential
Model description
Participants in Phase 1 will receive escalating doses and Phase 2 participants will receive a single dose.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07743541
Sponsor's protocol ID
NAPISTAR 1-03
Acronym
NAPISTAR 1-03
Status last verified
Jul 2026
First submitted
30 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TUB-040 - Dose escalation and TUB-040 - RP2D in people with Uterine Endometrial Cancer, run by Gilead Sciences at 4 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 30 inclusion and 30 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: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 Tubulis Clinical Trial Inquiries (+49 175 800 5594, ct-inquiries@tubulis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 3 years). 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 NCT07743541.

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 5 Aug 2026.

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