Trial · NCT04983407
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
NCT04983407, Phase 1, Phase 2, Terminated, Aravive, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma. Trials, record NCT04983407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04983407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
- NCT number
- NCT04983407
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Aravive, Inc.
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- batiraxcept, Nab paclitaxel, Gemcitabine
- First posted
- 2021-07-30
- Last updated
- 2023-10-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | 12 months | Measured by the number of patients with AEs in Phase 1b portion of the study. |
| Primary | Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study | 12 months | Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study. |
| Primary | Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study | 30 months | Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2. |
| Secondary | Pharmacokinetics: AUC | 30 months | Area under the batiraxcept concentration-time curve. |
| Secondary | Pharmacokinetics: Cmax | 30 months | Maximum observed batiraxcept concentration. |
| Secondary | Pharmacokinetics: Tmax | 30 months | Time of maximum observed batiraxcept concentration. |
| Secondary | Pharmacokinetics: t1/2 | 30 months | Apparent terminal half-life of batiraxcept. |
| Secondary | Pharmacodynamic marker assessment | 30 months | Change from the baseline in GAS6 serum levels. |
| Secondary | Anti-drug antibody (ADA) titers | 30 months | Change from baseline in ADA titer. |
| Secondary | Disease control rate | 30 months | Proportion of subjects who have a complete or partial response to therapy or maintain stable disease. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04983407
GET https://conductscience.org/api/trials/v1/NCT04983407/registered