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Anti-tumor antibiotic

Platinum resistant ovarian cancer for Non-Small Cell Lung Cancer (NAPISTAR1-01 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Tubulis GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until 30 days after last study drug
Awards & highlights

NAPISTAR1-01 Trial Summary

"This trial is testing a new drug, TUB-040, in patients with ovarian cancer and lung cancer to see how safe it is, how the body processes it, and how well it works.

Who is the study for?
This trial is for patients with ovarian cancer or recurrent/refractory adenocarcinoma non-small cell lung cancer. Participants must have a tumor that overexpresses NaPi2b and can receive intravenous treatments every 3 weeks. Specific eligibility details are not provided, but typically include factors like age, health status, and prior treatments.Check my eligibility
What is being tested?
The study tests TUB-040, an antibody-drug-conjugate targeting NaPi2b to deliver a topoisomerase I inhibitor directly to cancer cells. It's given IV every 3 weeks in two phases: finding the highest dose patients can tolerate (dose escalation) and then determining the best dose (dose optimization).See study design
What are the potential side effects?
While specific side effects of TUB-040 aren't listed here, similar drugs often cause symptoms like fatigue, nausea, hair loss, low blood counts leading to increased infection risk or bleeding tendencies. Side effects depend on individual patient reactions.

NAPISTAR1-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until 30 days after last study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until 30 days after last study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of MTD
Secondary outcome measures
Area Under Curve (AUC)
Determination of efficacy
Determination of immunogenicity
+4 more

NAPISTAR1-01 Trial Design

2Treatment groups
Experimental Treatment
Group I: Platinum resistant ovarian cancerExperimental Treatment1 Intervention
Group II: Non small cell lung cancer-adenocarcinomaExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Tubulis GmbHLead Sponsor
Guenter Fingerle-Rowson, MD, PhDStudy DirectorTubulis GmbH

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being admitted to participate in this trial?

"As per clinicaltrials.gov, the current trial is not actively seeking participants. Originally listed on 5/1/2024 and last updated on 3/6/2024, this study has concluded patient recruitment. Despite this trial's closure to enrollment, there are currently 3278 other studies open for participant recruitment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
2024. "FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06303505.
~67 spots leftby Jan 2027
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