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NSCLCPhase 2NCT07806773

Study of TUB-040 in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer

A Phase 2 study testing TUB-040 in people with NSCLC and Non Small Cell Lung Cancer, run by Gilead Sciences at 2 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
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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 unresectable or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Non Small Cell Lung Cancer
What is being tested?
TUB-040
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
Nov 2026to May 2029
Phase
Phase 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

  • Adults, male or nonpregnant, nonbreastfeeding female, age ≥18 years at the date of consent.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Documented radiographic progression on or after the most recent line of anticancer therapy.
  • Life expectancy of more than 12 weeks for disease-related mortality as evaluated by the INV.
  • At least 1 radiologically measurable lesion by RECIST v1.1, which can include a lesion in an irradiated field that shows progression according to RECIST v1.1.
  • Stable metastases to the central nervous system (CNS) are eligible only after definitive therapy (such as surgery, radiotherapy, stereotactic therapy) was provided and the individual is asymptomatic and off systemic steroids and anticonvulsants. Individuals with treated brain metastases that are no longer symptomatic may be included if they have recovered from the acute toxic effects of radiotherapy. A minimum of 7 days for targeted radiation and 14 days for whole brain radiation must have elapsed prior to Cycle 1 Day 1.
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  • Adequate hematologic function as indicated by:
  • Platelet count ≥ 100,000/mm3 (no platelet transfusion or growth factors, eg, eltrombopag, romiplostim, or interleukin-11 within 4 weeks before the first dose of study treatment)
  • Hemoglobin ≥ 9.0 g/dL (no packed red blood cell transfusion or growth factors [eg, erythropoietin, darbepoetin] within 4 weeks before the first dose of study treatment and/or long-acting white blood cell growth factors within 28 days before first dose of study treatment)
  • Absolute neutrophil count ≥ 1500/μL (no growth factors [eg, granulocyte colony stimulating factor, granulocyte macrophage-colony stimulating factor] within 4 weeks before the first dose of study treatment)
  • International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time ≤ 1.5 × upper limit of normal (ULN) in the absence of anticoagulation therapy. If individuals are on anticoagulation therapy with a specific INR goal, INR should be within the therapeutic range for the medical indication
  • Adequate hepatic function as defined by a total bilirubin level ≤ 1.5 × ULN, aspartate aminotransferase (AST) level ≤ 2.5 × ULN, and alanine aminotransferase (ALT) level ≤ 2.5 × ULN.
  • For documented Gilbert's syndrome, a total bilirubin < 3 × ULN is acceptable
  • For individuals with liver metastases, AST and ALT < 5 × ULN is acceptable
  • 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 metastases.
  • Adequate renal function defined by glomerular filtration rate (GFR) ≥ 50 mL/min (according to the Chronic Kidney Disease Epidemiology Collaboration formula).
  • Resolution of all adverse events (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 individuals 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).
  • Completed washout of prior therapy:
  • Systemic anticancer therapy within 5 half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment. Hormonal therapy is not considered anticancer therapy.
  • Radiotherapy ≥ 2 weeks prior to the first dose of study treatment
  • Willing to undergo a noncontrast high-resolution computed tomography scan of the chest and pulmonary function tests at screening.
  • Individuals with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening and they have completed curative antiviral therapy at least 4 weeks before enrollment.
  • 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 unless they have undergone permanent sterilization (ie, hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or are postmenopausal.
  • 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.

Who cannot join

  • Mixed histology NSCLC (eg, small cell lung cancer/NSCLC) or histology other than adenocarcinoma
  • Prior pneumonectomy
  • Newly identified or known unstable brain metastases, spinal cord compression, active CNS disease, progressive multifocal leukoencephalopathy, and/or carcinomatous meningitis.
  • Pregnant, lactating, or breastfeeding.
  • History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.
  • Prior treatment with an ADC-containing topoisomerase 1 (Topo-1) inhibitor payload (or other camptothecin derivatives) or any ADC targeting NaPi2b. ADCs with other payloads are allowed (eg, monomethyl auristatin E, monomethyl auristatin F, etc.).
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  • Discontinuation of the most recent systemic anticancer therapy due to hematologic toxicity.
  • Concomitant use of strong inhibitors or strong inducers of cytochrome P450 3A4.
  • 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.
  • Radiotherapy < 2 weeks prior to start of study treatment (planned C1D1), except in the case of stereotactic radiation to the brain, in which case the required interval is 7 days.
  • Major surgery within 21 days prior to signing ICF.
  • Active interstitial lung disease (ILD)/pneumonitis or history of noninfectious ILD/pneumonitis/radiation pneumonitis requiring steroid treatment.
  • Resting Fridericia's corrected QT interval (QTcF) > 470 msec. If a single QTcF is > 470 msec, the patient may enroll if the mean QTcF from 3 electrocardiograms (ECG) is < 470 msec.
  • History of nephrotic syndrome or proteinuria Grade ≥ 2.
  • Active keratitis or corneal disorder or history of corneal disease including history of herpes simplex virus keratitis 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 individual to the development of complications from the administration of protocol therapy.
  • Documented 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 unstable or worsening 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), hormonal therapy, immunotherapy, biologic, or corticosteroid therapy.
  • Live attenuated vaccines within 30 days prior to study enrollment.
  • Positive for hepatitis B surface antigen or hepatitis B DNA.
  • Acute, chronic, or severe recurrent infections (per INV's judgment) of active bacterial, viral, fungal, mycobacterial, or other infection of ≤ 14 days after systemic anti-infective treatment prior to randomization.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

2 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 States2 sites

  • START New Jersey

    East Brunswick, New Jersey, 08816

    START New Jersey, ct-inquiries@tubulis.com

  • START Los Angeles

    Los Angeles, California, 90025

    START Los Angeles, ct-inquiries@tubulis.com

Other trials in United States

About this study

Official title: A Randomized, Open-label, Phase 2a Dose Optimization Study of TUB-040 (a NaPi2b Antibody-drug Conjugate) in Participants With Unresectable or Metastatic Nonsquamous Non-small Cell Lung Cancer

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 unresectable or metastatic non-small cell lung cancer (NSCLC).

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

Being tested
TUB-040
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TUB-040Drug

    Administered IV

Study groups in NCT07806773
Study groupRoleWhat they receive
NSCLC Dose 1ExperimentalParticipants will receive TUB-040 administered as an intravenous (IV) infusion on Day 1 of each treatment cycle. Until disease progression, unacceptable toxicity, or withdrawal of consent.
Receives: Drug: TUB-040
NSCLC Dose 2ExperimentalParticipants will receive TUB-040 administered as an IV infusion on Day 1 of each treatment cycle. Until disease progression, unacceptable toxicity, or withdrawal of consent.
Receives: Drug: TUB-040

What is being measured

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

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

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

    Measured: From enrollment until 30 days after last dose of study drug

  2. Overall Response Rate (ORR)

    Assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 as assessed by the investigator (INV)

    Measured: Enrollment until approximately 80 days since last dose of study drug

Secondary outcomes (9)

  1. Duration of response (DoR)

    Duration of response (DoR) by RECIST v1.1 as assessed by the INV

    Measured: Up to approximately 24 months

  2. Disease control rate (DCR)

    Disease control rate (DCR) by RECIST v1.1 as assessed by the INV

    Measured: Up to approximately 24 months

  3. Progression-free survival (PFS)

    Progression-free survival (PFS) by RECIST v1.1 as assessed by the INV

    Measured: Up to approximately 24 months

  4. Overall survival (OS)

    Overall survival (OS)

    Measured: Up to approximately 24 months

  5. Pharmacokinetic (PK) Parameter: Cmax of TUB-040

    PK parameter of Maximum plasma/serum concentration (Cmax) of TUB-040

    Measured: Up to approximately 24 months

  6. Pharmacokinetic (PK) Parameter: Tmax

    PK parameter of Time to Cmax for TUB-040

    Measured: Up to approximately 24 months

  7. Pharmacokinetic (PK) Parameter: AUC

    PK parameter of Area under the concentration-time curve (AUC) for TUB-040

    Measured: Up to approximately 24 months

  8. Pharmacokinetic (PK) Parameter: t1/2

    PK parameter of Estimated half-life (t1/2) of TUB-040, if data collected allow

    Measured: Up to 3 yeaUp to approximately 24 months

  9. Percentage of Participants Who Develop Anti-TUB-040 Antibodies

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

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted8 Sep 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07806773
Sponsor's protocol ID
NAPISTAR 2-01
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TUB-040 in people with NSCLC and Non Small Cell Lung Cancer, run by Gilead Sciences at 2 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 26 inclusion and 22 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 phase mean?

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?

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) (time frame: From enrollment until 30 days after last dose of study drug). The study lists 2 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 NCT07806773.

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 16 Sep 2026.

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