Trial Title:
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients with PROC or R/r Adenocarcinoma NSCLC
NCT ID:
NCT06303505
Condition:
Ovarian Cancer
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
TUB-040
ADC
PROC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TUB-040
Description:
A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered
as an intravenous (IV) solution on day 1 of each treatment cycle
Arm group label:
Non small cell lung cancer-adenocarcinoma
Arm group label:
Platinum resistant ovarian cancer
Summary:
The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the
safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the
best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer.
TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor
cells which overexpress the target NaPi2b. The study consists of two parts: In dose
escalation, ovarian cancer patients and lung cancer patients receive increasing doses of
TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two
doses are compared with each other to determine which dose is optimal for patients.
TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop
due to side effects.
Criteria for eligibility:
Criteria:
Inclusion Criteria (for all patients)
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. Patients 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. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1, that includes at least 1 lesion not previously irradiated.
5. Eastern Cooperative Oncology Group (ECOG) 0-1.
6. Have a life expectancy of more than 12 weeks for disease-related mortality, as
evaluated by the INV.
7. Patients must be willing to sign an archival tissue release form for research
purposes and determination of biomarker (eg NaPi2b) expression.
8. Patients must be willing to undergo a non-contrast high resolution computed
tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at
screening.
9. Adequate organ function
10. 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).
11. Patients 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 patients assigned female at birth. Abstinence is acceptable only as true
abstinence 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,
symptothermal, post-ovulation methods), the rhythm method, and the withdrawal method
are not acceptable methods of contraception.
12. In the opinion of the investigator, the patient must be able to understand, give
written informed consent, and comply with all study-related procedures, medication
use, and evaluations.
13. The patient must not have a history of non-compliance with medical regimens or be
considered potentially unreliable and/or uncooperative.
14. The patient must be willing to sign and date the informed consent form (ICF)
Exclusion Criteria (for all patients)
1. The patient is pregnant, lactating or breastfeeding or has a positive serum
pregnancy test during the screening period.
2. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation,
including ADCs with deruxtecan, exatecan or camptothecan as a payload.
3. Disease that is refractory to topoisomerase-I inhibitors, defined as progression
during or within 6 months of the last infusion.
4. Patients 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.
5. Patients with spinal cord compression or active central nervous system disease.
6. Prior radiotherapy <2 weeks from trial inclusion.
7. Major surgery within 21 days prior to signing the ICF, unless the patient is
recovered at that time.
8. Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required
steroids or has current ILD/pneumonitis.
9. Has an oxygen saturation of <93% on room air at rest.
10. Has a forced vital capacity of <60% and diffusing capacity of the lung for carbon
monoxide <70%.
11. Has a QTcF >470 ms
12. History of nephrotic syndrome
13. Active corneal disease, or history of corneal disease within 12 months prior to
enrollment.
14. Active, uncontrolled impairment of the urogenital, renal, hepatobiliary,
cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the
opinion of the investigator, would predispose the patient to the development of
complications from the administration of protocol therapy.
15. 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.
16. 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).
17. Any concurrent chemotherapy, radiotherapy (except for local radiation therapy of
lesions that may cause imminent complications), immunotherapy, or corticoid therapy.
18. Live vaccines within 30 days prior to study entry.
19. Patients with acute or chronic infections such as:
1. Patients who are HBsAg positive are eligible if they have received HBV
anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load
prior to randomization.
2. Patients with a history of HCV infection are eligible if HCV viral load is
undetectable at screening.
3. HIV infected patients 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Christ Hospital
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christ Hospital Research Center
Facility:
Name:
Next Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Next Hospital Research Center
Phone:
703-7834510
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma
Country:
United States
Status:
Recruiting
Contact:
Last name:
OU Health Stephenson Cancer Research Center
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Leuven Clinical Research Center
Facility:
Name:
University Hospital Cologne Department of Internal Medicine I
Address:
City:
Cologne
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Cologne Hospital Research Center
Facility:
Name:
Clínica universidad de Navarra
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Clínica universidad de Navarra Research Center
Facility:
Name:
Next Oncology Dallas
Status:
Recruiting
Contact:
Phone:
+1 972-893-8800
Email:
ct-inquiries@tubulis.com
Start date:
June 12, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
Tubulis GmbH
Agency class:
Industry
Source:
Tubulis GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06303505
