TUB-040 for Non-Small Cell Lung Cancer
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive TUB-040 administered as an IV infusion on Day 1 of each treatment cycle. Until disease progression, unacceptable toxicity, or withdrawal of consent.
Participants will receive TUB-040 administered as an intravenous (IV) infusion on Day 1 of each treatment cycle. Until disease progression, unacceptable toxicity, or withdrawal of consent.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tubulis GmbH
Lead Sponsor
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 ...
3.
mountsinai.org
mountsinai.org/clinical-trials/fih-study-to-investigate-safety-pk-efficacy-of-napi2b-adc-tub-040-in-patients-with-proc-r-r-adenocarcinoma-nsclcFiH 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 ...
4.
cancernetwork.com
cancernetwork.com/view/tub-040-elicits-early-responses-in-platinum-resistant-ovarian-cancerTUB-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 ...
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