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RecruitingNCT06303505NAPISTAR1-01Updated Nov 3, 2026

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

A Phase 1/2 interventional study of TUB-040 and Bevacizumab in Ovarian Cancer and Non-small Cell Lung Cancer, sponsored by Gilead Sciences. Recruiting at 21 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Gilead Sciences · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Updated Nov 3, 2026No longer in Puerto RicoEnrollment updated+7 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
334
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical study is to learn more about the study drug, TUB-040, including its safety, tolerability, pharmacokinetics, and preliminary efficacy, and to determine the best dose of TUB-040 in participants with ovarian cancer or non-small cell lung cancer (NSCLC).

The primary objectives of this study are:

Phase 1: To determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) or the identified dose for optimization (IDO).

Phase 2a: To assess safety of TUB-040, the preliminary efficacy of TUB-040, and to identify the recommended phase II dose (RP2D) for further development of TUB-040 .

Phase 2b: To determine the efficacy of TUB-040 in patients with PROC.

02

Conditions studied

  • Ovarian Cancer
  • Non-small Cell Lung Cancer

Keywords

  • TUB-040
  • ADC
  • PROC
03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 334 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 692 studies on the registry; 26 are open to participants now.

Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.

Browse Gilead Sciences studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria (for all phases)

  1. Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
  2. Disease not amenable to curative intent treatment.
  3. Individuals have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.
  4. Individuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
  5. Radiologically by (RECIST) 1.1 as assessed by the INV.
  6. (ECOG) 0-1.
  7. Have a of more than 12 weeks for disease-related mortality, as evaluated by the INV.
  8. Individuals must be willing to sign an release form for research purposes and determination of biomarker expression.
  9. Individuals must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
  10. Adequate organ function
  11. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy or anticancer treatment such as but not limited to immune oncology therapy (IOs)).
  12. Individuals of (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of individuals assigned female at birth.
  13. In the opinion of the investigator, the individual must be able to understand, give written , and comply with all study-related procedures, medication use, and evaluations.
  14. The individual must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
  15. The individual must be willing to sign and date the informed consent form (ICF)

Key Exclusion Criteria (for all phases)

  1. The individual is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
  2. History of to exatecan or of the TUB-040 formulation.
  3. Individuals are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.
  4. Individuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.
  5. Prior radiotherapy \<2 weeks from trial inclusion.
  6. Major surgery within 21 days prior to signing the ICF, unless the individual is recovered at that time.
  7. Has a history of non-infectious interstitial lung disease/pneumonitis (ILD)/pneumonitis/radiation pneumonitis that required or has current ILD/pneumonitis.
  8. Has an oxygen saturation of \<93% on room air at rest.
  9. Has a >470 ms
  10. History of nephrotic syndrome
  11. Active corneal disease, or history of corneal disease within 12 months prior to enrollment.
  12. Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the individual to the development of complications from the administration of protocol therapy.
  13. History of another 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.
  14. Documented other concurrent non-malignant 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 (CHF) ( III or IV).
  15. Any anti-tumor chemotherapy, systemic anti-cancer therapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), hormonal therapy, immunotherapy, or corticoid therapy.
  16. Concurrent use of strong inhibitors or strong inducers of
  17. within 30 days prior to study entry.

  18. Individuals with acute or chronic infections such as:

    1. Individuals who are positive are eligible if they have received Hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.
    2. Individuals with a history of virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
    3. infected individuals must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
    4. Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
    5. History of severe and recurrent infections per INV judgment.
    6. History of progressive multifocal leukoencephalopathy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
334 participants (estimated)

Study arms

  • Experimental
    Phase 1: Cohort 1: Dose Escalation in Platinum Resistant Ovarian Cancer (PROC)

    Participants will receive escalating doses of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.

    Drug: TUB-040

  • Experimental
    Phase 1: Cohort 2: Dose Escalation in R/R NSCLC of the adenocarcinoma subtype

    Participants will receive escalating doses of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.

    Drug: TUB-040

  • Experimental
    Phase 1: Cohort 3: PROC, Combination with Bevacizumab (BEV)

    Participants will receive escalating doses of TUB-040 combined with BEV every 3 weeks until the disease progresses or the patient has to stop due to side effects.

    Drug: TUB-040 · Drug: Bevacizumab

  • Experimental
    Phase 2a: Dose Optimization in PROC

    Participants will receive two different dose levels of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.

    Drug: TUB-040

  • Experimental
    Phase 2b: Dose Expansion in PROC

    Patients will receive TUB-040 at the safe dose established during dose escalation until disease progression or unacceptable toxicity.

    Drug: TUB-040

Interventions

  • DrugTUB-040

    Administered intravenous (IV) on day 1 of each 21-day treatment cycle

  • DrugBevacizumab

    Administered IV

    Also known as: BEV

06

What researchers measure

Primary outcomes

  1. Phase 1: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)

    Time frame: First dose up to 21 days

  2. Phase 1 and 2a: Percentage of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)

    Time frame: First dose date up to 30 days post last dose (Up to 3 years)

  3. Phase 2a & 2b: Overall Response Rate (ORR) by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by BICR.

    Time frame: Up to 3 years

Secondary outcomes

  1. Phase 2a & 2b: Duration of Response (DOR) by BICR

    DOR is defined as the interval from the first documentation of CR or PR until the date of first documented disease progression or death, whichever comes first, as assessed by BICR.

    Time frame: Up to 3 years

  2. Phase 1, 2a & 2b: ORR by INV

    ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by Investigator (INV).

    Time frame: Up to 3 years

  3. Phase 1, 2a & 2b: DOR by INV

    DOR is defined as the interval from the first documentation of CR or PR until the date of first documented disease progression or death, whichever comes first, as assessed by INV.

    Time frame: Up to 3 years

  4. Phase 1, 2a & 2b: Progression-Free Survival (PFS) by INV

    PFS is defined as the time from first dose date until disease progression or death from any cause, whichever comes first, as assessed by INV.

    Time frame: Up to 3 years

  5. Phase 1, 2a & 2b: Disease Control Rate (DCR) by INV

    DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease, as assessed by INV.

    Time frame: Up to 3 years

  6. Phase 2a & 2b: Progression-Free Survival (PFS) by BICR

    PFS is defined as the time from first dose date until disease progression or death from any cause, whichever comes first, as assessed by BICR.

    Time frame: Up to 3 years

  7. Phase 2a & 2b: Disease Control Rate (DCR) by BICR

    DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease, as assessed by BICR.

    Time frame: Up to 3 years

  8. Phase 1, 2a & 2b: Percentage of Participants Experiencing Grade ≥3 Lab Abnormalities

    Time frame: Up to 3 years

  9. Phase 1: Percentage of Participants Experiencing Serious Adverse Events (SAEs)

    Time frame: First dose date up to 30 days post last dose (Up to 3 years)

  10. Phase 1 & 2a: Pharmacokinetic (PK) Parameter of TUB-040, total Monoclonal Antibody (mAb), and Free Exatecan: Cmax

    Cmax is defined as the maximum observed drug concentration.

    Time frame: Up to 3 years

  11. Phase 1 & 2a: PK Parameter of TUB-040, Total mAb, and Free Exatecan: Cmin

    The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmin will be derived).

    Time frame: Up to 3 years

  12. Phase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Tmax

    Tmax is defined as the time (observed time point) of Cmax.

    Time frame: Up to 3 years

  13. Phase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Area Under Curve (AUC)

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

    Time frame: Up to 3 years

  14. Phase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Half life (t1/2)

    t1/2 is defined as the terminal elimination half-life at steady state.

    Time frame: Up to 3 years

  15. Phase 1, 2a & 2b: Percentage of Participants Developing anti-TUB-040 antibodies and semiquantitative titer assessments

    Time frame: From enrollment until 30 days after last study drug

  16. Phase 2a & 2b: Overall Survival (OS)

    OS is defined as the length of time from first dose until the date of death from any cause.

    Time frame: Up to 3 years

  17. Phase 2a & 2b: Cancer Antigen (CA)-125 response according to Gynecological Cancer InterGroup (GCIG)

    Time frame: Up to 3 years

  18. Phase 2a & 2b: Percentage of Participants Experiencing TEAEs

    Time frame: First dose date up to 30 days post last dose date (Up to 3 years)

07

Study locations

19 of 21 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 42 months after the start.

Of 116 industry-sponsored phase 1/2 interventional studies under Ovarian Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 88. This study's planned 42 months is below that.

Counting every sponsor, half of 173 studies reached it within 65 months; a quarter within 44 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2024
First posted
Mar 12, 2024
StartActual
Jun 12, 2024
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
18 sites added, 26 sites removed; no longer in Puerto Rico
Show 18 added (11 United States, 2 Germany, 2 Spain, 1 Belgium, 1 Romania, 1 Ukraine)
  • University of Alabama at Birmingham · Birmingham, United States
  • Winship Cancer Institute Emory University · Atlanta, United States
  • Dana Farber Cancer Institute (DFCI) · Boston, United States
  • START New Jersey (Astera Cancer Center) · East Brunswick, United States
  • The Christ Hospital Physicians - Mt. Auburn · Cincinnati, United States
  • Ohio State University CRS · Columbus, United States
  • Stephenson Cancer Center · Oklahoma City, United States
  • Asante Rogue Region al Medical Center · Medford, United States
  • START Dallas Fort Worth · Fort Worth, United States
  • NEXT Oncology Dallas · Irving, United States
  • NEXT Virginia · Fairfax, United States
  • UZ Leuven - PPDS · Leuven, Belgium
  • Charité- Universitaetsmedizin Berlin · Berlin, Germany
  • University Hospital of Cologne · Cologne, Germany
  • ARENSIA Exploratory Medicine, LLC · Cluj-Napoca, Romania
  • Clínica Universidad de Navarra - Madrid · Madrid, Spain
  • NEXT Madrid, University Hospital Quironsalud Madrid · Madrid, Spain
  • ARENSIA Exploratory Medicine, LLC · Kyiv, Ukraine
Show 26 removed
  • The University of Alabama · Birmingham, United States
  • Yale Cancer Center · New Haven, United States
  • Emory University · Atlanta, United States
  • Norton Cancer Institute Research · Louisville, United States
  • Tufts · Boston, United States
  • Dana-Farber Cancer Institute · Boston, United States
  • START New Jersey East Brunswick · East Brunswick, United States
  • Christ Hospital · Cincinnati, United States
  • Ohio State University · Columbus, United States
  • OU Health Stephenson Cancer Center · Oklahoma City, United States
  • Asante / Heimann Cancer Center · Medford, United States
  • Allegheny Singer · Pittsburgh, United States
  • Spartanburg Regional · Spartanburg, United States
  • Start Dfw · Fort Worth, United States
  • Next Oncology Dallas · Irving, United States
  • Inova Schar Cancer Institute · Fairfax, United States
  • Next Oncology Virginia · Fairfax, United States
  • Providence Sacred Heart Medical Center · Spokane, United States
  • UZ Leuven · Leuven, Belgium
  • Charité Universitätsmedizin Berlin · Berlin, Germany
  • University Hospital Cologne Department of Internal Medicine I · Cologne, Germany
  • Puerto Rico Cancer Clinical Trials · San Juan, Puerto Rico
  • Arensia Exploratory Medicine · Cluj-Napoca, Romania
  • Clínica universidad de Navarra · Madrid, Spain
  • NEXT Oncology Madrid · Madrid, Spain
  • Arensia Exploratory Medicine · Kyiv, Ukraine
Nov 3, 2026
Enrollment
250→334
Nov 3, 2026
Eligibility
19 criteria edited
What changed in the criteria
  • EditedParticipantsIndividuals have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.
  • EditedParticipantsIndividuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
  • EditedParticipantsIndividuals must be willing to sign an archival tissue release form for research purposes and determination of biomarker expression.
  • EditedParticipantsIndividuals must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
  • EditedResolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy or anticancer treatment such as but not limited to immune oncology therapy (IOs)).
  • EditedParticipantsIndividuals of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of participantsindividuals assigned female at birth.
  • EditedIn the opinion of the investigator, the participantindividual must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
  • EditedThe participantindividual must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
  • EditedThe participantindividual must be willing to sign and date the informed consent form (ICF)
  • EditedThe participantindividual is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
  • EditedParticipantsIndividuals are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.
  • EditedParticipantsIndividuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.
  • EditedMajor surgery within 21 days prior to signing the ICF, unless the participantindividual is recovered at that time.
  • EditedHas a history of non-infectious interstitial lung disease/pneumonitis (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
  • EditedActive, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the participantindividual to the development of complications from the administration of protocol therapy.
  • EditedParticipantsIndividuals with acute or chronic infections such as:
  • EditedParticipantsIndividuals who are HBsAg positive are eligible if they have received Hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.
  • EditedParticipantsIndividuals with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
  • EditedHIV infected participantsindividuals must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
Nov 3, 2026
Interventions
Added Drug: Bevacizumab. Arms added: Phase 1: Cohort 1: Dose Escalation in Platinum Resistant Ovarian Cancer (PROC)·Phase 1: Cohort 2: Dose Escalation in R/R NSCLC of the adenocarcinoma subtype·Phase 1: Cohort 3: PROC, Combination with Bevacizumab (BEV)·Phase 2a: Dose Optimization in PROC·Phase 2b: Dose Expansion in PROC; arms removed: Platinum resistant ovarian cancer·Non small cell lung cancer-adenocarcinoma·Platinum resistant ovarian cancer in combination with Bevacizumab
Nov 3, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedPhase 1: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)[Time frame: First dose up to 21 days
Nov 3, 2026
Secondary outcomes
3 edited, 1 time frame changed, 2 description edited
What changed in the outcomes
  • EditedPhase 1 & 2a: Pharmacokinetic (PK) Parameter of TUB-040, total Monoclonal Antibody (mAb), and Free Exatecan: CmaxTime frame: Up to 3 years
  • EditedPhase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Half life (T1t1/2)Time frame: Up to 3 years
  • EditedPhase 2a & 2b: Cancer Antigen (CA)-125 response according to Gynecological Cancer InterGroup (GCIG)Time frame: Up to 3 years
  • Time framePhase 1, 2a & 2b: Percentage of Participants Experiencing Grade ≥3 Lab AbnormalitiesFirst dose date up to last dose date plus 30 days → Up to 3 years
  • DescriptionPhase 1, 2a & 2b: Progression-Free Survival (PFS) by INV: how it is measured was reworded
  • DescriptionPhase 2a & 2b: Progression-Free Survival (PFS) by BICR: how it is measured was reworded
Nov 3, 2026
Contact
Study contact changed: c•••@tubulis.com · •••5594→G•••@gilead.com · •••2300. See the current contact
Nov 3, 2026
Site contacts
Changed at 2 sites. See the sites
Show 2 sites
  • Mount Sinai · New York, United StatesContact removed c•••@tubulis.com
  • START Mountain Region · West Valley City, United StatesContact removed c•••@tubulis.com · •••4750
Nov 3, 2026
Sponsor
Tubulis GmbH→Gilead Sciences
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    18 sites added, 26 sites removed; no longer in Puerto Rico
    Show 18 added (11 United States, 2 Germany, 2 Spain, 1 Belgium, 1 Romania, 1 Ukraine)
    • University of Alabama at Birmingham · Birmingham, United States
    • Winship Cancer Institute Emory University · Atlanta, United States
    • Dana Farber Cancer Institute (DFCI) · Boston, United States
    • START New Jersey (Astera Cancer Center) · East Brunswick, United States
    • The Christ Hospital Physicians - Mt. Auburn · Cincinnati, United States
    • Ohio State University CRS · Columbus, United States
    • Stephenson Cancer Center · Oklahoma City, United States
    • Asante Rogue Region al Medical Center · Medford, United States
    • START Dallas Fort Worth · Fort Worth, United States
    • NEXT Oncology Dallas · Irving, United States
    • NEXT Virginia · Fairfax, United States
    • UZ Leuven - PPDS · Leuven, Belgium
    • Charité- Universitaetsmedizin Berlin · Berlin, Germany
    • University Hospital of Cologne · Cologne, Germany
    • ARENSIA Exploratory Medicine, LLC · Cluj-Napoca, Romania
    • Clínica Universidad de Navarra - Madrid · Madrid, Spain
    • NEXT Madrid, University Hospital Quironsalud Madrid · Madrid, Spain
    • ARENSIA Exploratory Medicine, LLC · Kyiv, Ukraine
    Show 26 removed
    • The University of Alabama · Birmingham, United States
    • Yale Cancer Center · New Haven, United States
    • Emory University · Atlanta, United States
    • Norton Cancer Institute Research · Louisville, United States
    • Tufts · Boston, United States
    • Dana-Farber Cancer Institute · Boston, United States
    • START New Jersey East Brunswick · East Brunswick, United States
    • Christ Hospital · Cincinnati, United States
    • Ohio State University · Columbus, United States
    • OU Health Stephenson Cancer Center · Oklahoma City, United States
    • Asante / Heimann Cancer Center · Medford, United States
    • Allegheny Singer · Pittsburgh, United States
    • Spartanburg Regional · Spartanburg, United States
    • Start Dfw · Fort Worth, United States
    • Next Oncology Dallas · Irving, United States
    • Inova Schar Cancer Institute · Fairfax, United States
    • Next Oncology Virginia · Fairfax, United States
    • Providence Sacred Heart Medical Center · Spokane, United States
    • UZ Leuven · Leuven, Belgium
    • Charité Universitätsmedizin Berlin · Berlin, Germany
    • University Hospital Cologne Department of Internal Medicine I · Cologne, Germany
    • Puerto Rico Cancer Clinical Trials · San Juan, Puerto Rico
    • Arensia Exploratory Medicine · Cluj-Napoca, Romania
    • Clínica universidad de Navarra · Madrid, Spain
    • NEXT Oncology Madrid · Madrid, Spain
    • Arensia Exploratory Medicine · Kyiv, Ukraine
    Enrollment 250→334
    Eligibility 19 criteria edited
    What changed in the criteria
    • EditedParticipantsIndividuals have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.
    • EditedParticipantsIndividuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
    • EditedParticipantsIndividuals must be willing to sign an archival tissue release form for research purposes and determination of biomarker expression.
    • EditedParticipantsIndividuals must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
    • EditedResolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy or anticancer treatment such as but not limited to immune oncology therapy (IOs)).
    • EditedParticipantsIndividuals of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of participantsindividuals assigned female at birth.
    • EditedIn the opinion of the investigator, the participantindividual must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
    • EditedThe participantindividual must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
    • EditedThe participantindividual must be willing to sign and date the informed consent form (ICF)
    • EditedThe participantindividual is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
    • EditedParticipantsIndividuals are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.
    • EditedParticipantsIndividuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.
    • EditedMajor surgery within 21 days prior to signing the ICF, unless the participantindividual is recovered at that time.
    • EditedHas a history of non-infectious interstitial lung disease/pneumonitis (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
    • EditedActive, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the participantindividual to the development of complications from the administration of protocol therapy.
    • EditedParticipantsIndividuals with acute or chronic infections such as:
    • EditedParticipantsIndividuals who are HBsAg positive are eligible if they have received Hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.
    • EditedParticipantsIndividuals with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
    • EditedHIV infected participantsindividuals must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedPhase 1: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)[Time frame: First dose up to 21 days
    Secondary outcomes 3 edited, 1 time frame changed, 2 description edited
    What changed in the outcomes
    • EditedPhase 1 & 2a: Pharmacokinetic (PK) Parameter of TUB-040, total Monoclonal Antibody (mAb), and Free Exatecan: CmaxTime frame: Up to 3 years
    • EditedPhase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Half life (T1t1/2)Time frame: Up to 3 years
    • EditedPhase 2a & 2b: Cancer Antigen (CA)-125 response according to Gynecological Cancer InterGroup (GCIG)Time frame: Up to 3 years
    • Time framePhase 1, 2a & 2b: Percentage of Participants Experiencing Grade ≥3 Lab AbnormalitiesFirst dose date up to last dose date plus 30 days → Up to 3 years
    • DescriptionPhase 1, 2a & 2b: Progression-Free Survival (PFS) by INV: how it is measured was reworded
    • DescriptionPhase 2a & 2b: Progression-Free Survival (PFS) by BICR: how it is measured was reworded
    Interventions Added Drug: Bevacizumab. Arms added: Phase 1: Cohort 1: Dose Escalation in Platinum Resistant Ovarian Cancer (PROC)·Phase 1: Cohort 2: Dose Escalation in R/R NSCLC of the adenocarcinoma subtype·Phase 1: Cohort 3: PROC, Combination with Bevacizumab (BEV)·Phase 2a: Dose Optimization in PROC·Phase 2b: Dose Expansion in PROC; arms removed: Platinum resistant ovarian cancer·Non small cell lung cancer-adenocarcinoma·Platinum resistant ovarian cancer in combination with Bevacizumab
    Sponsor Tubulis GmbH→Gilead Sciences
    Contact Study contact changed: c•••@tubulis.com · •••5594→G•••@gilead.com · •••2300. See the current contact
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • Mount Sinai · New York, United StatesContact removed c•••@tubulis.com
    • START Mountain Region · West Valley City, United StatesContact removed c•••@tubulis.com · •••4750
    + 4 other changes: index terms, identifiers, verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06303505
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Jun 12, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Gilead Clinical Study Information Center
Contact
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Anti-NaPi2b/Exatecan Antibody-drug Conjugate TUB-040

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