Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT07736937

Run by

Tubulis GmbH

People needed

72

Starts

2026-03-30

Expected to finish

2028-04-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• UCL Louvain — Brussels, Belgium (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• CHU de Liege — Liège, Belgium (enrolling)
• ARENSIA Exploratory Medicine — Kyiv, Ukraine

Full record on ClinicalTrials.gov

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