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

Phase 1

Recruiting

• Conditions: Ovarian Cancer; Non-small Cell Lung Cancer
• Interventions: Drug: TUB-040

• Registration Number: NCT06303505
• Lead Sponsor: Tubulis GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-12
• Study Start: 2024-06-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Platinum resistant ovarian cancer	TUB-040	-
Non small cell lung cancer-adenocarcinoma	TUB-040	-

Primary Outcome Measures

Name	Time	Method
Determination of MTD	From enrollment until 30 days after last study drug	The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria

Secondary Outcome Measures

Name	Time	Method
Determination of immunogenicity	From enrollment until 30 days after last study drug	Number and percentage of patients developing anti-TUB-040 antibodies, and semiquantitative titer assessment. It is measured at cycles 1, 2, 3, 4, 6, 8, 10, post treatment
Determination of efficacy	From enrollment until 30 days after last study drug	ORR by investigator assest Recist 1.1
Through plasma/serum concentration (Cmin)	From enrollment until 30 days after last study drug	The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmin will be derived).
The time taken to reach the maximum concentration (Tmax)	From enrollment until 30 days after last study drug	The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Maximum plasma/serum concentration (Cmax)	From enrollment until 30 days after last study drug	The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Half life (T1/2)	From enrollment until 30 days after last study drug	The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (T1/2 will be derived).
Area Under Curve (AUC)	From enrollment until 30 days after last study drug	The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (AUC will be derived).

Trial Locations

Locations (10)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

NEXT Oncology Madrid; 🇪🇸 Madrid, Spain

Guy's Hospital; 🇬🇧 London, United Kingdom

Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

OU Health Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Next Oncology Virginia; 🇺🇸 Fairfax, Virginia, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

University Hospital Cologne Department of Internal Medicine I; 🇩🇪 Cologne, Germany

Next Oncology Dallas; 🇺🇸 Irving, Texas, United States

Clínica universidad de Navarra; 🇪🇸 Madrid, Spain