Trial · NCT07883577
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Incidence and Severity of Adverse Events (AEs) | Up to approximately 27 months | AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Any events of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded based on the American Society for Transplantation and Cellular Therapy (ASTCT) criteria |
| Primary | Part 2: Incidence and Severity of Adverse Events (AEs) | Up to approximately 27 months | AEs will be graded according to NCI CTCAE v5.0. Any events of CRS and ICANS will be graded based on the ASTCT criteria |
| Primary | Part 1A: Nature and Frequency of Dose-limiting Toxicities (DLTs) | From Cycle 1 (C1) Day 1 to the last day in C1 (Cycle 1 = 14-35 days) | |
| Primary | Part 2A: Nature and Frequency of DLTs | From C1 Day 1 to the last day in C1 (Cycle 1 = 14-35 days) | |
| Primary | Parts 1A and 1B: Recommended Phase 2 Dose (RP2D) Range of RO7821657 | Up to approximately 27 months | |
| Primary | Part 2A: RP2D Range of RO7821657 | Up to approximately 27 months | |
| Secondary | Parts 1 and 2: Serum Concentration of RO7821657 | Up to approximately 27 months | |
| Secondary | Parts 1 and 2: Objective Response Rate (ORR) | Up to approximately 27 months | |
| Secondary | Parts 1 and 2: Disease Control Rate (DCR) | Up to approximately 27 months | |
| Secondary | Parts 1 and 2: Duration of Response (DoR) | Up to approximately 27 months | |
| Secondary | Parts 1 and 2: Progression-free Survival (PFS) | Up to approximately 27 months | |
| Secondary | Parts 1 and 2: PFS Rate | At 6 months | |
| Secondary | Parts 1 and 2: Overall Survival (OS) Rate | At 6 months | |
| Secondary | Parts 1 and 2: Correlation of Baseline Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Tumor Expression With Clinical Activity | Up to approximately 27 months | |
| Secondary | Part 1B: Cluster of Differentiation 8 (CD8) Expression in Tumor Tissue | Up to approximately 27 months | |
| Secondary | Parts 1C and 2B: Percentage of Participants With Presence, Frequency, Severity and Interference of Symptomatic Treatment Toxicities as Assessed by NCI Patient-reported Outcomes (PRO)-CTCAE | Up to approximately 27 months | |
| Secondary | Parts 1C and 2B: Change From Baseline in Symptomatic Treatment Toxicities as Assessed by NCI PRO-CTCAE | Up to approximately 27 months | |
| Secondary | Parts 1C and 2B: Percentage of Participants Troubled by Treatment Symptoms, as Assessed by Single Item European Organisation for Research and Treatment of Cancer Item Library 46 (EORTC IL46) | Up to approximately 27 months |
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
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GET https://conductscience.org/api/trials/v1/NCT07883577/registered