FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Tubulis GmbH
Study ID
NCT06303505
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TUB-040 — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Platinum resistant ovarian cancer
  • Experimental: Non small cell lung cancer-adenocarcinoma
  • Experimental: Platinum resistant ovarian cancer in combination with Bevacizumab

Primary Outcome Measure

Determination of MTD [ Time Frame: From enrollment until 30 days after last study drug ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
The University of AlabamaBirminghamAlabama35294
The University of Alabama
[email protected]
Mount SinaiNew YorkNew York10011
Mount Sinai Research Center
[email protected]
Christ HospitalCincinnatiOhio45219
Christ Hospital Research Center
[email protected]
+1 972-893-8800
Ohio State UniversityColumbusOhio43210#
Ohio State University Research Center
[email protected]
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104
OU Health Stephenson Cancer Research Center
[email protected]
Next Oncology DallasIrvingTexas75039
[email protected]
+1 972-893-8800
Next Oncology VirginiaFairfaxVirginia22031
Next Hospital Research Center
703-7834510

Find similar trials in Birmingham, AL

By condition
Lung cancerOvarian cancer
By specialty
OncologyLung oncologyLung diseaseGynecologic oncologyWomen's health
By research site
The University of Alabama· Birmingham, ALMount Sinai· New York, NYChrist Hospital· Cincinnati, OHOhio State University· Columbus, OHOU Health Stephenson Cancer Center· Oklahoma City, OKNext Oncology Dallas· Irving, TX

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