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Ovarian CancerPhase 1/2NAPISTAR1-01NCT06303505

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 study testing TUB-040 and Bevacizumab in people with Ovarian Cancer and Non-small Cell Lung Cancer, run by Gilead Sciences at 21 sites in 7 countries.

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

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ovarian Cancer, Non-small Cell Lung Cancer
What is being tested?
TUB-040 and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
21 sitesin 7 countries
Study dates
12 Jun 2024to Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
  • Disease not amenable to curative intent treatment.
  • 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.
  • Individuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
  • Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the INV.
  • Eastern Cooperative Oncology Group (ECOG) 0-1.
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  • Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.
  • Individuals must be willing to sign an archival tissue release form for research purposes and determination of biomarker expression.
  • 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.
  • Adequate organ function
  • 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)).
  • Individuals 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 individuals assigned female at birth.
  • In the opinion of the investigator, the individual must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
  • The individual must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
  • The individual must be willing to sign and date the informed consent form (ICF)

Who cannot join

  • The individual is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
  • History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.
  • 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 investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.
  • Individuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.
  • Prior radiotherapy <2 weeks from trial inclusion.
  • Major surgery within 21 days prior to signing the ICF, unless the individual is recovered at that time.
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  • Has a history of non-infectious interstitial lung disease/pneumonitis (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
  • Has an oxygen saturation of <93% on room air at rest.
  • Has a QTcF >470 ms
  • History of nephrotic syndrome
  • Active corneal disease, or history of corneal disease within 12 months prior to enrollment.
  • 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.
  • 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 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) (New York Heart Association III or IV).
  • 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.
  • Concurrent use of strong inhibitors or strong inducers of CYP3A4
  • Live vaccines within 30 days prior to study entry.
  • Individuals with acute or chronic infections such as:
  • Individuals 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.
  • Individuals with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
  • HIV infected individuals must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
  • Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
  • History of severe and recurrent infections per INV judgment.
  • History of progressive multifocal leukoencephalopathy
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

21 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Gilead Clinical Study Information Center contact

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

21 sites in 7 countries

United States13 sites, 13 recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Recruiting

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

    Recruiting

  • The Christ Hospital Physicians - Mt. Auburn

    Cincinnati, Ohio, 45219

    Recruiting

  • Ohio State University CRS

    Columbus, Ohio, 43210

    Recruiting

  • START New Jersey (Astera Cancer Center)

    East Brunswick, New Jersey, 08816

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Recruiting

  • START Dallas Fort Worth

    Fort Worth, Texas, 76104

    Recruiting

  • NEXT Oncology Dallas

    Irving, Texas, 75039

    Recruiting

  • Asante Rogue Region al Medical Center

    Medford, Oregon, 97504

    Recruiting

  • Mount Sinai

    New York, New York, 10011

    Recruiting

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Recruiting

Other trials in United States

Germany2 sites, 2 recruiting

  • Charité- Universitaetsmedizin Berlin

    Berlin, 13353

    Recruiting

  • University Hospital of Cologne

    Cologne, 50937

    Recruiting

Other trials in Germany

Spain2 sites, 2 recruiting

  • Clínica Universidad de Navarra - Madrid

    Madrid, 28027

    Recruiting

  • NEXT Madrid, University Hospital Quironsalud Madrid

    Madrid, 28223

    Recruiting

Other trials in Spain

Belgium1 site, 1 recruiting

  • UZ Leuven - PPDS

    Leuven, 3000

    Recruiting

Other trials in Belgium

Romania1 site, 1 recruiting

  • ARENSIA Exploratory Medicine, LLC

    Cluj-Napoca, 40015

    Recruiting

Other trials in Romania

Ukraine1 site

  • ARENSIA Exploratory Medicine, LLC

    Kyiv, 01135

    Active, not recruiting

Other trials in Ukraine

United Kingdom1 site

  • Guy's Hospital

    London, SE1 9RT

    Active, not recruiting

Other trials in United Kingdom

About this study

Official title: A Multicenter, First-in-human Dose Escalation and Optimization Phase I/IIa Study to Investigate Safety, Tolerability, PK, and Efficacy of the NaPi2b ADC TUB-040 in Patients With Platinum-resistant High-grade Ovarian Cancer (PROC) or r/r Adenocarcinoma Non-small Cell Lung Cancer (NSCLC)

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:

Read more

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.

Being tested
TUB-040, Bevacizumab
Keywords
TUB-040, ADC, PROC
Medical subject headings
Ovarian Neoplasms, 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 intravenous (IV) on day 1 of each 21-day treatment cycle

  • BevacizumabDrug

    Also called BEV

    Administered IV

Study groups in NCT06303505
Study groupRoleWhat they receive
Phase 1: Cohort 1: Dose Escalation in Platinum Resistant Ovarian Cancer (PROC)ExperimentalParticipants will receive escalating doses of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Receives: Drug: TUB-040
Phase 1: Cohort 2: Dose Escalation in R/R NSCLC of the adenocarcinoma subtypeExperimentalParticipants will receive escalating doses of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Receives: Drug: TUB-040
Phase 1: Cohort 3: PROC, Combination with Bevacizumab (BEV)ExperimentalParticipants 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.
Receives: Drug: TUB-040; Drug: Bevacizumab
Phase 2a: Dose Optimization in PROCExperimentalParticipants 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.
Receives: Drug: TUB-040
Phase 2b: Dose Expansion in PROCExperimentalPatients will receive TUB-040 at the safe dose established during dose escalation until disease progression or unacceptable toxicity.
Receives: Drug: TUB-040

What is being measured

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

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

    Measured: First dose up to 21 days

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

    Measured: 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.

    Measured: Up to 3 years

Secondary outcomes (18)

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 3 years

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

    Measured: Up to 3 years

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

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 3 years

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

    Measured: 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.

    Measured: Up to 3 years

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

    Measured: Up to 3 years

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

    Measured: First dose date up to 30 days post last dose date (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 posted12 Mar 2024
  2. Study start12 Jun 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06303505
Sponsor's protocol ID
NAPISTAR 1-01
Other IDs
2024-511074-80
Acronym
NAPISTAR1-01
Status last verified
Oct 2026
First submitted
6 Feb 2024
Last updated
3 Nov 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 1/2 study testing TUB-040 and Bevacizumab in people with Ovarian Cancer and Non-small Cell Lung Cancer, run by Gilead Sciences at 21 sites in 7 countries.

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 15 inclusion and 25 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Germany, Spain, Belgium, Romania and 2 more countries. 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 Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.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 any Dose-limiting Toxicities (DLTs) (time frame: First dose up to 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06303505.

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 3 Nov 2026.

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