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

NCT07736937 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NAPISTAR 1-02
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 5

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Day 1 up to Day 21 of each treatment cycle

Secondary Outcomes (13)

• PK Characterization of TUB-040: Cmax

  Day 1 up to Day 21 of each treatment cycle

• PK Characterization of TUB-040: Tmax

  Day 1 up to Day 21 of each treatment cycle

• PK Characterization of TUB-040: AUC

  Day 1 up to Day 21 of each treatment cycle

• PK Characterization of TUB-040: t1/2

  Day 1 up to Day 21 of each treatment cycle

• Immunogenicity of TUB-040 when used with SOC.

  Enrollment to approximately 80 days after last dose.

Study Arms (1)

Phase 1b Dose Escalation

EXPERIMENTAL

Drug TUB-040 administered in combination with carboplatin (Carbo) and bevacizumab (BEV)

Drug: TUB-040 + Carbo + BEV

Interventions

TUB-040 + Carbo + BEV DRUG

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.

Phase 1b Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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 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

Sponsors & Collaborators

• Tubulis GmbH: lead

Study Sites (5)

UCL Louvain

Brussels, Belgium

RECRUITING

UZ Gent

Ghent, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU de Liege

Liège, Belgium

RECRUITING

ARENSIA Exploratory Medicine

Kyiv, Ukraine

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Tubulis Medical Director

  Tubulis GmbH

  STUDY DIRECTOR

Central Study Contacts

Tubulis Clinical Trial Inquiries

CONTACT

+ 49 175 800 5594; ct-inquiries@tubulis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 30, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); BE (4)