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Anti-tumor antibiotic

TUB-040 for Ovarian and Lung Cancers (NAPISTAR1-01 Trial)

Phase 1 & 2
Recruiting
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
No Placebo-Only Group

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.
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).
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.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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Who is running the clinical trial?

Tubulis GmbHLead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
Guenter Fingerle-Rowson, MD, PhDStudy DirectorTubulis GmbH
~67 spots leftby Jan 2027
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