Trial · NCT07361003
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: dose limiting toxicity (DLT) | At the end of Cycle 1 (each cycle is 28 days) | |
| Primary | Phase Ib: Adverse Events | From signing informed consent form until 28 days after the last dose of study treatment, up to about 18 months | The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0 |
| Primary | Phase Ib: Tolerance | From signing informed consent until 28 days after the last dose of study treatment, for up to 18 months | Number of participants who experienced adverse event related dose interruption, dose reduction and treatment discontinuation as assessed by investigators. |
| Primary | Phase III: overall survival (OS) | For about 18 months from the randomization of the last participant | OS is the time interval from the date of randomization to death from any cause. |
| Secondary | Suvemcitug Serum concentration change over time of all participants | For about 6 cycles, each cycle is 28 days. | Area under the serum concentration versus time curve (AUC) |
| Secondary | Peak Suvemcitug serum concentration (Cmax) of all participants | For about 6 cycles, each cycle is 28 days | |
| Secondary | The time taken to reach peak Suvemcitug concentration after administration (Tmax) | For about 6 cycles, each cycle is 28 days | |
| Secondary | The time required for Suvemcitug concentration in the serum to decrease by half (t1/2) | For about 6 cycles, each cycle is 28 days | |
| Secondary | Serum anti-drug antibody (ADA) incidence of Suvemcitug | For about 6 cycles, each cycle is 28 days | The number of participants with anti-drug antibody (ADA) tested positive from blood |
| Secondary | Serum anti-drug antibody (ADA) duration of Suvemcitug | For about 6 cycles, each cycle is 28 days | Duration of ADA measures how long the antibody persists in the blood |
| Secondary | Serum anti-drug antibody (ADA) titer of Suvemcitug | For about 6 cycles, each cycle is 28 days | ADA titer measures how much anti-drug antibody is present in the blood |
| Secondary | Objective Response Rate (ORR) of all participants | From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months. | Proportion of participants who have a complete or partial response relative to baseline as assessed according to RECIST 1.1 criteria |
| Secondary | Duration of response (DoR) of all participants | From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
| Secondary | Disease control rate (DCR) of all participants | From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months. | Proportion of participants who have a complete or partial response, or stable disease relative to baseline as assessed according to RECIST 1.1 criteria |
| Secondary | Progression free survival (PFS) of all participants | From the date when the first dose of Suvemcitug is administered until radiological progression, initiation of new anti-cancer therapy, death or withdrawal from study, whichever came first, assessed up to 18 months. | |
| Secondary | Phase Ib: overall survival (OS) | For about 18 months from the randomization of the last participant | OS is the time interval from the date of randomization to death from any cause |
| Secondary | Phase III: Adverse Events | From signing informed consent form until 28 days after the last dose of study treatment, for about 18 months. | The incidence (number of participants) and severity of adverse events (AE) and serious adverse events (SAE) assessed by CTCAE v5.0 |
| Secondary | Phase III: quality of life - EORTC QLQ-C30 | Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months | Quality of life evaluated by participant reported questionnaires: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 . |
| Secondary | Phase III: quality of life - Euro Qol (EQ)-5D | Questionnaires will be collected from participants at baseline, and all efficacy evaluation visits, for up to 18 months | Evaluated by participant reported questionnaires: EuroQol- 5 Dimension Questionnaire. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07361003/registered