TUB-040 for Non-Small Cell Lung Cancer

Not yet recruiting at 1 trial location
TC
Overseen ByTubulis Clinical Trial Inquiries
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, TUB-040, to evaluate its safety and effectiveness for individuals with advanced non-small cell lung cancer that is inoperable or has metastasized. Researchers aim to determine the drug's efficacy and potential side effects. Participants will receive TUB-040 through IV infusion at varying doses. The trial seeks individuals who have experienced lung cancer progression despite previous treatments and have stable brain metastases. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that TUB-040 is likely to be safe for humans?

Research has shown that TUB-040 was safe in earlier studies. In trials involving patients with a type of ovarian cancer unresponsive to standard treatments, TUB-040 was well-tolerated and did not cause serious lung problems or low platelet counts, issues often seen with similar treatments. This suggests that TUB-040 might be safe for patients, as serious side effects have not been common. However, since this study is in an early stage, researchers continue to collect safety information specifically for non-small cell lung cancer.12345

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Researchers are excited about TUB-040 for non-small cell lung cancer (NSCLC) because it offers a potentially new approach compared to current treatments like chemotherapy and targeted therapies. Unlike these traditional options, TUB-040 is administered as an intravenous infusion and may target cancer cells in a novel way, potentially leading to better outcomes for patients. This treatment is particularly promising because it aims to address the disease directly while minimizing the typical side effects associated with existing therapies.

What evidence suggests that TUB-040 might be an effective treatment for non-small cell lung cancer?

Studies have shown that TUB-040, a new treatment for non-small cell lung cancer (NSCLC), has promising results. In earlier research, more than half of the patients responded positively, with significant tumor shrinkage. In this trial, participants will receive TUB-040 in one of two different dosages as part of separate treatment arms. TUB-040 combines an antibody with a cancer-fighting drug, delivering the drug directly to cancer cells. This targeted approach may lead to better results and fewer side effects. Early studies found the treatment well-tolerated, with no severe side effects reported. Overall, TUB-040 shows potential as an effective treatment option for patients with advanced NSCLC.23467

Who Is on the Research Team?

TM

Tubulis Medical Director

Principal Investigator

Tubulis GmbH

Are You a Good Fit for This Trial?

This trial is for adults with nonsquamous non-small cell lung cancer that cannot be removed by surgery or has spread to other parts of the body. Participants should generally be in good health aside from their cancer.

Inclusion Criteria

My liver function tests are within the acceptable range for this study.
Life expectancy of more than 12 weeks for disease-related mortality as evaluated by the investigator
At least 1 radiologically measurable lesion by RECIST v1.1, including lesions in irradiated fields showing progression
See 14 more

Exclusion Criteria

History of hypersensitivity to exatecan or excipients of TUB-040 formulation
I have had a lung removed in the past.
Resting QTcF >470 msec unless mean of 3 ECGs <470 msec
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TUB-040 administered as an IV infusion on Day 1 of each treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent

Up to approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 80 days since last dose of study drug

What Are the Treatments Tested in This Trial?

Interventions

  • TUB-040

Trial Overview

The study is testing a new drug called TUB-040 to see if it is safe, how well people tolerate it, and how effective it is at treating advanced non-small cell lung cancer. All participants will receive TUB-040.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: NSCLC Dose 2Experimental Treatment1 Intervention
Group II: NSCLC Dose 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tubulis GmbH

Lead Sponsor

Trials
2
Recruited
230+

Citations

First positive data TUB-040 in ovarian cancer

TUB-040 achieved an Overall Response Rate (ORR) of 59% (cORR 50%), with ORR ranging from 50% to 67% First interim results show clinical proof- ...

NAPISTAR 1-01: An international phase I/II trial of the novel ...

TUB-040 is an innovative antibody-drug conjugate (ADC) exhibiting a robust bystander effect. investigating TUB-040 in platinum-resistant ...

FiH Study to Investigate Safety, PK and Efficacy of the ...

Non Small Cell Lung Cancer. Patients have exhausted the standard of care treatment (SoC) with expected survival benefit. Have a life expectancy of more than 12 ...

TUB-040 Elicits Early Responses in Platinum-Resistant ...

TUB-040 demonstrated promising response rates of more than 50% across doses of the NaPi2b-targeted antibody-drug conjugate (ADC) ...

TUB-040, a Homogeneous and Hydrophilic NaPi2b-Targeting ...

TUB-040 demonstrated a promising tolerability profile in rat studies, There were no signs of lung toxicity, treatment of ovarian cancer

FiH Study to Investigate Safety, PK and Efficacy of the ...

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

Study on the Safety and Tolerability of TUB-040 for Patients ...

This medication is being tested in patients with platinum-resistant high-grade ovarian cancer and relapsed or refractory adenocarcinoma non-small cell lung ...