Ovarian CancerPhase 1/2OCNCT07736937
Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer
A Phase 1/2 study testing TUB-040 + Carbo + BEV in people with Ovarian Cancer, run by Gilead Sciences at 8 sites in 3 countries.
Trial summary
The goal of this clinical study is to learn more about the safety, tolerability, and preliminary effectiveness of TUB-040 when given in combination with standard ovarian cancer treatments in participants with high-grade epithelial serous or endometrioid ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- TUB-040 + Carbo + BEV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 30 Mar 2026to Apr 2028
- 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
- Female ≥ 18 years of age at the time of the first screening visit
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Have platinum-sensitive ovarian cancer (PSOC) defined as: Patients who had recurrences (radiologically confirmed) to platinum-based therapy and have responded to the last platinum therapy received before study entry and did not progress within 6 months (182 days) of the date of the last dose of platinum-based systemic treatment.
- Radiologically measurable disease in at least 1 lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, that can include a lesion in an irradiated field and that shows progression according to RECIST v1.1
- Patients must have progressed radiographically on or after their most recent line of anticancer therapy
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- Adequate hematologic function as indicated by:
- Platelet counts ≥100,000/mm3 (no transfusion or growth factors, e.g., eltrombopag, romiplostim, or IL-11 within 4 weeks before first dose)
- Hemoglobin ≥9.0 g/dL (no transfusion or growth factors e.g. erythropoietin (EPO), darbepoetin within 4 weeks before first dose or long-acting white blood cell growth factors within 20 days before first dose)
- Absolute neutrophil count (ANC) ≥1500/μL (no growth factors, e.g., granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks before first dose)
- International normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN) in the absence of anticoagulation therapy. If patients are on anticoagulation therapy with a specific INR goal, INR should be within the therapeutic range for the medical indication.
- Adequate hepatic function defined as total bilirubin level ≤1.5 × ULN, an aspartate aminotransferase (AST) level ≤2.5 × ULN, and an alanine aminotransferase (ALT) level ≤2.5 × ULN
- For documented Gilbert's Syndrome, a total bilirubin <3 × ULN is accepted
- For patients with liver metastases, AST and ALT <5 × ULN is accepted
- Alkaline phosphatase < 2.5 x ULN, except if there is an alternative explanation for ALP elevation rather than hepatic failure, such as the presence of bone metastasis
- Adequate renal function defined by glomerular filtration rate ≥60 mL/min (according to the Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI, formula [Appendix B]).
- Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (e.g., NaPi2b) expression. The patient must have an adequate tumor tissue sample available for biomarker assessment by the central laboratory. Mandatory is either a tissue (FFPE) block or a minimum of 6 freshly cut unstained sections based on the most recently available tumor sample. If no archival specimens are available, a new biopsy must be performed. For patients in which a fresh biopsy poses unacceptable clinical risk in the judgment of the treating investigator, enrollment may be considered on a case-by-case basis only after discussion with the Sponsor Medical Monitor.
- Resolution of all acute toxic effects of prior therapy or surgical procedures to Grade ≤1 including peripheral neuropathy (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone) replacement, corticosteroid treatment on ≤10 mg daily prednisone (or equivalent)
- Patients with previous systemic topoisomerase 1 inhibitor treatment (e.g., Topotecan) or patients that are previously treated with ADCs are allowed (except for ADCs with a topoisomerase 1 inhibitor, such as SN38 or other camptothecin derivatives as payload or any ADC targeting NaPi2b)
- Completed washout of prior therapy:
- Systemic anti-neoplastic therapy: five half-lives or 4 weeks, whichever is shorter prior to first dose of study drug. Hormonal therapy is not considered anti-neoplastic therapy.
- Radiotherapy: last dose ≥ 2 weeks from first dose of study drug
- Completed major surgery at least 4 weeks prior from first dose of study drug and recovered from side effects to Grade ≤1.
- Viral infections:
- Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B (HBV) anti-viral therapy for at least 4 weeks and have undetectable HBV viral load Note: Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post-completion of study intervention.
- Patients with history of hepatitis C viral (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Patients must have completed curative anti-viral therapy at least 4 weeks before enrollment
- Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of ≤1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus at minimum 5 half-lives and 6 months after last dose of either TUB-040, carboplatin, or bevacizumab, whichever is later, in the case of patients of childbearing potential. Abstinence is acceptable only when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g. calendar ovulation, symptom-thermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception.
- Note: A pregnancy test (urine or serum test or per institutional guideline) 72 hours before enrollment is required in WOCBP. Within 72 hours before enrollment, if a positive urine pregnancy test result is confirmed using a serum test, then the patient should not be enrolled into the study. Pregnancy tests (urine or serum test per institutional guideline) should be performed within 72h and resulted prior to the administration of any study treatment, at End of Treatment, and during Follow-Up as mandated by the Schedule of Assessments. In Follow-Up, this is continued monthly for 5-half-lives + 6 months after the last dose of any drug under study, at minimum. Women who have undergone a hysterectomy and/or bilateral salpingo-oophorectomy are exempted from testing.
- Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.
- Note: The half-life of TUB-040 is approximately 6 days.
- Female patients will be considered post-menopausal if they have undergone bilateral salpingectomy, and/or bilateral oophorectomy, and/or hysterectomy or have been amenorrheic for 12 months without an alternative medical cause (treatment with antihormonal therapies is considered an alternative medical cause). The following age specific requirements apply:
- Women <50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all hormonal replacement therapy and/or if they have luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.
- Women ≥50 years of age will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all hormonal replacement therapy or had radiation-induced menopause with most recent menses >1 year ago or had chemotherapy-induced menopause with most recent menses >1 year ago.
- In the opinion of the INV, the patient must be able to understand, must be willing to sign informed consent form (ICF) and comply with all study-related procedures, medication use, and evaluations.
- Patients must have 1-2 prior lines of systemic platinum therapy and have not progressed within 182 days after the date of the last dose of platinum.
- Notes:
- Neoadjuvant ± adjuvant is considered as one line of therapy.
- Maintenance therapy (e.g., BEV, poly adenosine diphosphate-ribose polymerase inhibitors (PARPi)) does not count as a line of therapy.
- Prior treatment may include BEV
- Prior treatment with PARPi is required (for patients who were previously documented to be HRD positive or have a germline or somatic BRCA 1/2 mutation), if PARPi therapy was locally approved at the time of testing.
Who cannot join
- Patients with clear-cell, mucinous histology, mixed histology with mucinous component, sarcoma, sarcomatous component, or low-grade ovarian cancer
- Patients with platinum refractory ovarian cancer (OC) (Platinum refractory is defined as disease that has not responded to a primary platinum-based regimen or progressed within 30 days after primary platinum-based therapy) or platinum resistant ovarian cancer
- Patient pregnant, lactating or breastfeeding or having a positive serum pregnancy test during the screening period
- Previous systemic topoisomerase-1 inhibitor treatment (except Topotecan)
- History of hypersensitivity to monoclonal antibodies, exatecan or excipients of the TUB-040 formulation.
- Note: The excipients of TUB-040 are listed in the IB.
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- Patients with unresolved malignant bowel obstruction (including patients with radiological findings indicating possible bowel obstruction on CT scans), history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess or Patients on total parenteral nutrition (TPN)
- Prior thoracocentesis for therapeutic drainage of malignant effusion < 4 weeks from trial inclusion and repeated paracentesis for therapeutic drainage of malignant effusion < 4 weeks before trial inclusion
- Prior radiotherapy to the pelvis or abdomen (Dose Escalation phase only)
- Patients with serum albumin level <2,5 g/dL (subjects should not have received IV albumin within 4 weeks of the test)
- Participation in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives (whichever is shorter) of any investigational pharmacologic agents before study treatment
- Patients with untreated spinal cord compression or cerebrovascular accident/stroke within <6 months of enrollment
- Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time
- History of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis
- Documented cardiac comorbidities: Corrected QT interval > 470 msec on the screening ECG, unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, uncontrollable hypertension (≥Grade 3), uncontrollable arrhythmias, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV) or severe aortic stenosis
- Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary (including liver cirrhosis), 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
- Demyelinating diseases: History of multiple sclerosis or of progressive multifocal leukoencephalopathy
- 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.
- Any concurrent anti-cancer chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), hormonal therapy, immunotherapy, or corticosteroid therapy, other than that permitted in Section 8.8.
- Live vaccines within 30 days prior to study entry or any known unresolved and active bacterial, viral (e.g. Hep B, Hep C, Varicella or CMV), fungal, mycobacterial, or other infection at screening
- History of hypersensitivity to Carbo and risk of further cumulative toxicity with additional platinum, including but not limited to myelosuppression, with febrile neutropenia, Grade 4 hematotoxicity, neuropathy Grade ≥2, renal insufficiency during prior platinum-based therapy
- Non-healing wounds, ulcers, or bone fractures
- History of posterior reversible encephalopathy syndrome
- Recent history of hemoptysis of ≥1/2 teaspoon of red blood within 4 weeks before first study treatment,
- History of Grade 4 thromboembolic events
- Hypertension ≥ Grade 3 that is not controlled with medical management
- Clinically significant proteinuria: urine-protein (UPC) ratio ≥ 1.0 or urine dipstick result ≥ 2+; patients with UPC ratio ≥ 1.0 or ≥ 2+ proteinuria should undergo 24-hour urine collection and must show result < 1 gram of protein in 24-hour period.
- Any patient who is required to take strong CYP3A4 inhibitors or inducers (see also Prohibited Medication and Guidance for Potential Use section).
- Note: If it is clinically acceptable to replace such medication with a different medication which is not a strong CYP3A4 inhibitor or inducer, then the patient may be eligible.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
Belgium4 sites, 4 recruiting
- Recruiting
UCL Louvain
Brussels
UCL Louvain
- Recruiting
UZ Gent
Ghent
UZ Gent
- Recruiting
UZ Leuven
Leuven
UZ Leuven
- Recruiting
CHU de Liege
Liège
CHU de Liege
United States3 sites, 3 recruiting
- Recruiting
Start Njeb
East Brunswick, New Jersey, 08816
- Recruiting
Start Cal
Los Angeles, California, 90025
- Recruiting
Start Nyli
New York, New York, 11042
Ukraine1 site, 1 recruiting
- Not yet recruiting
ARENSIA Exploratory Medicine
Kyiv
ARENSIA Exploratory Medicine
About this study
Official title: A Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of TUB-040, in Combination With Standard Ovarian Cancer Drugs in Patients With High-grade Epithelial Serous or Endometrioid Epithelial Ovarian Cancer OC)
The goal of this clinical study is to learn more about the safety, tolerability, and preliminary effectiveness of TUB-040 when given in combination with standard ovarian cancer treatments in participants with high-grade epithelial serous or endometrioid ovarian cancer.
This study will also evaluate the appropriate dose of TUB-040 when used with carboplatin (Carbo) and bevacizumab (BEV), including determining the maximum tolerated dose (MTD) in participants with platinum-sensitive ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- TUB-040 + Carbo + BEV
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUB-040 + Carbo + BEVDrug
Ph1b: A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered along with carboplatin (Carbo) and bevacizumab (BEV) as an intravenous (IV) solution on day 1 of each treatment cycle for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | Drug TUB-040 administered in combination with carboplatin (Carbo) and bevacizumab (BEV) Receives: Drug: TUB-040 + Carbo + BEV |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of TUB-040 in combination with standard ovarian cancer drugs
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Measured: From enrollment until 30 days after last study drug
Maximum Tolerated Dose (MTD) of TUB-040 with standard of care (SOC) treatment
Occurrence of DLTs (Dose limiting toxicities) at different dose levels (during first treatment cycle)
Measured: Day 1 up to Day 21 of each treatment cycle
Secondary outcomes (13)
PK Characterization of TUB-040: Cmax
PK parameters of TUB-040 ADC including maximum concentration Cmax
Measured: Day 1 up to Day 21 of each treatment cycle
PK Characterization of TUB-040: Tmax
PK parameters of TUB-040 ADC including time to Cmax (Tmax)
Measured: Day 1 up to Day 21 of each treatment cycle
PK Characterization of TUB-040: AUC
PK parameters of TUB-040 ADC including area under the curve (AUC)
Measured: Day 1 up to Day 21 of each treatment cycle
PK Characterization of TUB-040: t1/2
PK parameters of TUB-040 ADC including as far as collected data allow an estimation of half-life (t1/2)
Measured: Day 1 up to Day 21 of each treatment cycle
Immunogenicity of TUB-040 when used with SOC.
Incidence and titers of anti-drug antibodies (ADA) against TUB-040
Measured: Enrollment to approximately 80 days after last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: ORR
Objective response rate (ORR) by RECIST v1.1 assessed by Investigator (INV)
Measured: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: TTR
Time to first response (TTR) by RECIST v1.1 assessed by Investigator (INV)
Measured: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: DoR
Duration of response (DoR) by RECIST v1.1 assessed by Investigator (INV)
Measured: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: PFS
Progression-free survival (PFS) by RECIST v1.1 assessed by Investigator (INV)
Measured: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: GCIG
Number of patients with Gynecologic Cancer Intergroup (GCIG) CA-125 criteria clinical responses
Measured: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: Incidence SAEs
Incidence of serious adverse events (SAEs)
Measured: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: Incidence ≥ Grade 3 lab abnormalities
Incidence of ≥ Grade 3 laboratory abnormalities
Measured: Enrollment until approximately 80 days since last dose.
Evaluate survival rate
Overall survival (OS) assessed by INV
Measured: Enrollment until disease progression (or approximately 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start30 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tubulis Medical Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736937
- Sponsor's protocol ID
- NAPISTAR 1-02
- Other IDs
- 2025-524691-33-00, 2025
- Acronym
- OC
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of TUB-040, in Combination With Standard Ovarian Cancer Drugs in Patients With High-grade Epithelial Serous or Endometrioid Epithelial Ovarian Cancer OC)
- ClinicalTrials.gov ID
- NCT07736937
- Acronym / sponsor ID
- OC / NAPISTAR 1-02
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn more about the safety, tolerability, and preliminary effectiveness of TUB-040 when given in combination with standard ovarian cancer treatments in participants with high-grade epithelial serous or endometrioid ovarian cancer.
This study will also evaluate the appropriate dose of TUB-040 when used with carboplatin (Carbo) and bevacizumab (BEV), including determining the maximum tolerated dose (MTD) in participants with platinum-sensitive ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose Escalation | Experimental | Drug: TUB-040 + Carbo + BEVDrug TUB-040 administered in combination with carboplatin (Carbo) and bevacizumab (BEV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Female ≥ 18 years of age at the time of the first screening visit
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer.
- Have platinum-sensitive ovarian cancer (PSOC) defined as: Patients who had recurrences (radiologically confirmed) to platinum-based therapy and have responded to the last platinum therapy received before study entry and did not progress within 6 months (182 days) of the date of the last dose of platinum-based systemic treatment.
- Radiologically measurable disease in at least 1 lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, that can include a lesion in an irradiated field and that shows progression according to RECIST v1.1
Key exclusion criteria (29 listed)
- Patients with clear-cell, mucinous histology, mixed histology with mucinous component, sarcoma, sarcomatous component, or low-grade ovarian cancer
- Patients with platinum refractory ovarian cancer (OC) (Platinum refractory is defined as disease that has not responded to a primary platinum-based regimen or progressed within 30 days after primary platinum-based therapy) or platinum resistant ovarian cancer
- Patient pregnant, lactating or breastfeeding or having a positive serum pregnancy test during the screening period
- Previous systemic topoisomerase-1 inhibitor treatment (except Topotecan)
- History of hypersensitivity to monoclonal antibodies, exatecan or excipients of the TUB-040 formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUB-040 + Carbo + BEVPh1b: A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered along with carboplatin (Carbo) and bevacizumab (BEV) as an intravenous (IV) solution on day 1 of each treatment cycle for up to 6 cycles. | Drug | Phase 1b Dose Escalation |
Primary outcome
To determine the safety and tolerability of TUB-040 in combination with standard ovarian cancer drugs
Time frame: From enrollment until 30 days after last study drug
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Maximum Tolerated Dose (MTD) of TUB-040 with standard of care (SOC) treatment
Time frame: Day 1 up to Day 21 of each treatment cycle
Occurrence of DLTs (Dose limiting toxicities) at different dose levels (during first treatment cycle)
13 secondary outcomes
PK Characterization of TUB-040: Cmax
Time frame: Day 1 up to Day 21 of each treatment cycle
PK Characterization of TUB-040: Tmax
Time frame: Day 1 up to Day 21 of each treatment cycle
PK Characterization of TUB-040: AUC
Time frame: Day 1 up to Day 21 of each treatment cycle
PK Characterization of TUB-040: t1/2
Time frame: Day 1 up to Day 21 of each treatment cycle
Immunogenicity of TUB-040 when used with SOC.
Time frame: Enrollment to approximately 80 days after last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: ORR
Time frame: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: TTR
Time frame: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: DoR
Time frame: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: PFS
Time frame: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: GCIG
Time frame: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: Incidence SAEs
Time frame: Enrollment until approximately 80 days since last dose.
Preliminary efficacy and safety of TUB-040 with SOC until progression: Incidence ≥ Grade 3 lab abnormalities
Time frame: Enrollment until approximately 80 days since last dose.
Evaluate survival rate
Time frame: Enrollment until disease progression (or approximately 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tubulis Medical Director study director
Gilead Sciences
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TUB-040 + Carbo + BEV in people with Ovarian Cancer, run by Gilead Sciences at 8 sites in 3 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 40 inclusion and 29 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 1 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 8 sites in Belgium, United States, Ukraine. 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?
To determine the safety and tolerability of TUB-040 in combination with standard ovarian cancer drugs (time frame: From enrollment until 30 days after last 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?
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 1 Sep 2026.