Trial · NCT04300140
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0 | 10 months | Safety and tolerability of AVB-S6-500 in combination with cabozantinib. |
| Primary | Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib | 10 months | Measured by dose limiting toxicities experienced in Phase 1b |
| Primary | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (ORR) | 30 months | Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. ORR is proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Primary | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (ORR) | 30 months | Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib + nivolumab in Phase 2 Part B. ORR is proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Primary | Anti-tumor activity of AVB-S6-500 alone (ORR) | 30 months | Measured by objective response rate (ORR) in patients receiving AVB-S6-500 in Phase 2 Part C. ORR is proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Primary | Anti-tumor activity of AVB-S6-500 alone (DOR) | 30 months | Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 2 Part C. DOR is measured from the date of partial or complete response to therapy until the cancer progresses. |
| Primary | Anti-tumor activity of AVB-S6-500 alone (CBR) | 30 months | Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 in Phase 2 Part C. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease. |
| Primary | Anti-tumor activity of AVB-S6-500 alone (PFS) | 30 months | Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 2 Part C. PFS is the time from treatment until radiological disease progression or death. |
| Primary | Anti-tumor activity of AVB-S6-500 alone (OS) | 60 months | Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 2 Part C. OS is the time from the start of the treatment until death. |
| Secondary | Pharmacokinetics: AUC | 30 months | Area under the AVB-S6-500 concentration-time curve. |
| Secondary | Pharmacokinetics: Cmax | 30 months | Maximum observed AVB-S6-500 concentration. |
| Secondary | Pharmacokinetics: Tmax | 30 months | Time of maximum observed AVB-S6-500 concentration. |
| Secondary | Pharmacokinetics: t1/2 | 30 months | Apparent terminal half-life of AVB-S6-500. |
| 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 | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (CBR) | 30 months | Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease. |
| Secondary | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (DOR) | 30 months | Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. DOR is measured from the date of partial or complete response to therapy until the cancer progresses. |
| Secondary | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (OS) | 60 months | Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. OS is the time from the start of the treatment until death. |
| Secondary | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (PFS) | 30 months | Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A, PFS is the time from treatment until radiological disease progression or death. |
| Secondary | Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (DOR) | 30 months | Measured by duration of response (DOR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. DOR is measured from the date of partial or complete response to therapy until the cancer progresses. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04300140/registered