Trial · NCT03000257
A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors
NCT03000257, Phase 1, Completed, AbbVie
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors. Trials, record NCT03000257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03000257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Budigalimab (ABBV-181) in Participants With Advanced Solid Tumors
- NCT number
- NCT03000257
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 182 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Advanced Solid Tumors
- Interventions
- Venetoclax, Rovalpituzumab Tesirine, ABBV-181
- First posted
- 2016-12-22
- Last updated
- 2022-04-14
- Other registries' IDs
- eudract:2016-002520-89
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03000257
GET https://conductscience.org/api/trials/v1/NCT03000257/registered?page=2