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

ConditionsOvarian CancerNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTubulis GmbH

About this trial

The purpose of this multicenter, 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 participants 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 three parts: In dose escalation, ovarian cancer participants and lung cancer participants 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 participants. In dose expansion, a single dose will be used in a larger number of participants.

TUB-040 is given IV every 3 weeks until the disease progresses or the participants has to stop due to side effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.

Disease not amenable to curative intent treatment.

Participants 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.

Participants with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.

Disqualifiers

The participant is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.

History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.

Participants 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.

Participants with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: Platinum resistant ovarian cancerExperimental treatment 1 intervention
Group B: Non small cell lung cancer-adenocarcinomaExperimental treatment 1 intervention
Group C: Platinum resistant ovarian cancer in combination with BevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)[

Time frame
First dose up to 21 days
2

Phase 1 and 2a: Percentage of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)

Time frame
First dose date up to 30 days post last dose (Up to 3 years)
3

Phase 2a & 2b: Overall Response Rate (ORR) by Blinded Independent Central Review (BICR)

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by BICR.

Time frame
Up to 3 years

Secondary outcomes

1

Phase 2a & 2b: Duration of Response (DOR) by BICR

DOR is defined as the interval from the first documentation of CR or PR until the date of first documented disease progression or death, whichever comes first, as assessed by BICR.

Time frame
Up to 3 years
2

Phase 1, 2a & 2b: ORR by INV

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by Investigator (INV).

Time frame
Up to 3 years
3

Phase 1, 2a & 2b: DOR by INV

DOR is defined as the interval from the first documentation of CR or PR until the date of first documented disease progression or death, whichever comes first, as assessed by INV.

Time frame
Up to 3 years
4

Phase 1, 2a & 2b: Progression-Free Survival (PFS) by INV

PRS is defined as the time from first dose date until disease progression or death from any cause, whichever comes first, as assessed by INV.

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tubulis GmbH

Lead sponsor

Source ClinicalTrials.gov
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