A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3).
-
- STATUS
- Recruiting
-
- participants needed
- 110
-
- sponsor
- Boehringer Ingelheim
Summary
To determine the maximum tolerated dose(s) (MTD) or the Recommended Dose for Expansion (RDE) and dosing regimen for further development of BI 764532. The MTDs will be defined based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period in studied regimens. The Recommended Dose for Expansion (RDE) will be guided by overall safety, efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) assessments.
Additional objectives are to document the safety and tolerability of BI 764532, to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals.
Phase Ib will further explore BI 764532 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.
Details
Condition | Patients With Small Cell Lung Carcinoma and Other Neoplasms |
---|---|
Age | 18years - 100years |
Treatment | BI 764532 |
Clinical Study Identifier | NCT04429087 |
Sponsor | Boehringer Ingelheim |
Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteerStudy AnnotationsStudy Notes
Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.