Clinical trialPhase 1Completed
Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.
A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies
- Outcome
- Finished, no results posted
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- 25 April 2017
- Expected end
- 18 June 2021
- Enrollment
- 120 participants
- Sites
- 12
- Primary outcomes
- Incidence of DLTs, AEs, SAEs and dose reductions / interruptions for NIS793; Incidence of DLTs, AEs, SAEs and dose reductions/interruptions for NIS793 in combination with PDR001
- Sponsor
- Industry
- Results posted
- No
- Last update
- 31 January 2022
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.
Papers 2
- Builds on itPhase I/Ib, open-label, multicenter, dose-escalation study of the anti-TGF-β monoclonal antibody, NIS793, in combinatio… DOI 10.1136/jitc-2023-007353↗
- Builds on itα-PD-1 therapy elevates Treg/Th balance and increases tumor cell pSmad3 that are both targeted by α-TGFβ antibody to pr… DOI 10.1186/s40425-018-0493-9↗