Trial · NCT04950075
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival per RECISTv1.1 by real time IRR comparing INBRX-109 and placebo | 3 years | Progression-free survival per RECISTv1.1 will be determined. |
| Secondary | Overall survival of patients comparing INBRX-109 and placebo | 3 years | Overall Survival in the ITT population |
| Secondary | ORR per RECISTv1.1 by real-time IRR. | 3 years | Tumor response will be determined by RECISTv1.1. |
| Secondary | PFS per RECISTv1.1 by Investigator assessment | 3 years | PFS per RECISTv1.1, by Investigator assessment, comparing INBRX-109 and placebo. |
| Secondary | Quality of life assessed by EORTC questionnaire for cancer patients (QLQ-C30) comparing INBRX-109 and placebo | 3 years | Quality of life will be determined. |
| Secondary | DCR per RECISTv1.1 by real-time IRR | 3 years | measured by DCR per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo |
| Secondary | DOR per RECISTv1.1 by real-time IRR | 3 years | evaluate duration of response (DOR) per RECISTv1.1, assessed by central real-time IRR, comparing INBRX-109 and placebo |
| Secondary | To evaluate the safety and tolerability of INBRX-109 | 3 years | Adverse events will be assessed and severity assigned by using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. |
| Secondary | Characterize the pharmacokinetics of INBRX-109. | 3 years | AUC0-inf, AUC0-last, AUC0-21d, Cmax, Ctrough, Tmax will be estimated using a standard non-compartmental method as the data allow. Other PK parameters (λz, t½, Vd, CL, and accumulation ratios RCmax, RCtrough) will be calculated if data permit. |
| Secondary | Immunogenicity of INBRX-109 | 3 years | Frequency of anti-drug antibodies against INBRX-109 will be determined. |
| Other | Evaluate Quality of Life | 3 years | QoL per EORTC QLQ-C30, EQ-5D-5L, PGI-C, PGI-S |
| Other | Potential predictive response biomarkers | 3 years | Evaluate the relationship between potential predictive response biomarkers and efficacy of INBRX-109 |
| Other | PFS per RECISTv1.1 by Investigator assessment | 3 years | evaluate the anticancer efficacy of INBRX-109 as measured by PFS (by Investigator assessment) for crossover population after treatment with INBRX-109 |
| Other | ORR per RECISTv1.1 by Investigator assessment | 3 years | evaluate the anticancer efficacy of INBRX-109 as measured by ORR (by Investigator assessment) for crossover population after treatment with INBRX-109 |
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/NCT04950075/registered