Trial · NCT03000257
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Recommended Phase 2 Dose (RPTD) for Budigalimab | Up to 6 months | If a maximum tolerated dose (MTD) is reached, the RPTD of budigalimab will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and other available data. |
| Primary | Part 1: Maximum tolerated dose (MTD) of Budigalimab | Up to 6 months | MTD will be defined at the highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity. |
| Primary | Part 1 and Part 3: Terminal Half-life (t1/2) of Budigalimab | Up to 4 Weeks | Terminal phase elimination half-life (t1/2) of Budigalimab |
| Primary | Part 1 and Part 3: Maximum Observed Serum Concentration (Cmax) of Budigalimab | Up to 12 Weeks | Maximum Serum Concentration (Cmax) of Budigalimab |
| Primary | Part 1 and Part 3: Time to Cmax (Tmax) of Budigalimab | Up to 12 Weeks | Time to maximum plasma concentration of Budigalimab |
| Primary | Part 1 and Part 3: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Budigalimab | Up to 12 Weeks | Area Under the Plasma Concentration-time Curve from time 0 to last measurable concentration (AUCt) of Budigalimab |
| Primary | Part 2: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Rovalpituzumab Tesirine Combination | Up to 6 Months | The safety and tolerability of a single dose of Budigalimab in combination with Rovalpituzumab Tesirine will be assessed in patients with advanced small cell lung cancer (SCLC) to determine the RPTD and schedule for the combination. |
| Primary | Part 3: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Venetoclax Combination. | Up to 6 Months | The safety and tolerability of Budigalimab in combination with venetoclax will be assessed in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) to determine the RPTD for the combination. |
| Primary | Part 3: Maximum Observed Serum Concentration (Cmax) for Venetoclax | Up to 12 Weeks | Maximum Serum Concentration (Cmax) for Venetoclax |
| Primary | Part 3: Area Under the Serum Concentration Time Curve from Time 0 to 24 Hours Post-dose (AUC(0-24)) of Venetoclax | Up to 12 Weeks | Area Under the Plasma Concentration-time Curve from time 0 to time 0 to 24 hours post-dose (AUC(0-24)) of Venetoclax |
| Primary | Part 3: Time to Cmax (Tmax) of Venetoclax | Up to 12 Weeks | Time to maximum plasma concentration of of Venetoclax |
| Primary | Part 1, Part 2, Part 3: Number of Participants with Adverse Events | From first dose of study drug until 90 days following last dose of study drug (up to 24 months) | An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Secondary | Part 2: Terminal Half-life (t1/2) of Budigalimab | Up to 4 Weeks | Terminal phase elimination half-life (t1/2) of Budigalimab |
| Secondary | Part 2: Terminal Half-life (t1/2) of Rovalpituzumab Tesirine | Up to 4 Weeks | Terminal phase elimination half-life (t1/2) of Rovalpituzumab Tesirine |
| Secondary | Part 2: Maximum Observed Serum Concentration (Cmax) of Rovalpituzumab Tesirine | Up to 12 Weeks | Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine |
| Secondary | Part 2: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Rovalpituzumab Tesirine | Up to 12 Weeks | Area Under the Plasma Concentration-time Curve from time 0 to last measurable concentration (AUCt) of Rovalpituzumab Tesirine |
| Secondary | Part 2: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Budigalimab | Up to 12 Weeks | Area Under the Plasma Concentration-time Curve from time 0 to last measurable concentration (AUCt) of Budigalimab |
| Secondary | Part 2: Time to Cmax (Tmax) of Budigalimab | Up to 12 Weeks | Time to maximum plasma concentration of Budigalimab |
| Secondary | Part 2: Time to Cmax (Tmax) of Rovalpituzumab Tesirine | Up to 12 Weeks | Time to maximum plasma concentration of Rovalpituzumab Tesirine |
| Secondary | Part 1 and Part 3: Objective response rate (ORR) | First dose of study drug through at least 30 days after last dose of study drug. | ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT03000257/registered