Trial · NCT07912593
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B | First Cycle (21 days in Part A and 28 days in Part B) | Proportion of participants who experience at least 1 Dose Limiting Toxicity (DLT) |
| Primary | Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B | Average of 6 months | Incidence of AEs, treatment discontinuations due to AEs, changes from baseline in laboratory assessments, ECGs and vital signs |
| Primary | Select the Recommended Phase 2 Dose(s) (RP2D) | Average of 6 months | Safety Parameters as described for primary outcomes |
| Primary | Evaluate efficacy of ETX-929 monotherapy and ETX-929 in combination with cetuximab at the RP2D(s) in Part B and Part D | Average of 6 months | Objective response rate (ORR) according to RECIST v1.1 |
| Secondary | Characterize the Cmax (PK) of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B | First treatment cycle (21 day-cycles in Part A and 28-day cycles in Part B) | Maximum observed plasma concentration (Cmax) of ETX-929 |
| Secondary | Characterize the Tmax (PK) of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B | First treatment cycle (21 day-cycles in Part A and 28-day cycles in Part B) | Calculated time to reach maximum observed plasma concentration of ETX-929 |
| Secondary | Characterize the AUC (PK) of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B | First treatment cycle (21 day-cycles in Part A and 28-day cycles in Part B) | Calculated area under the plasma concentration curve (AUC) of ETX-929 |
| Secondary | Assess preliminary efficacy of ETX-929 monotherapy in Part A and ETX-636 plus cetuximab combination therapy in Part B | Average of 6 months | Objective response rate (ORR) and clinical benefit rate (CBR) based on RECIST v1.1 |
| Secondary | Evaluate measures of efficacy of ETX-929 monotherapy in Part C and ETX-929 plus cetuximab combination therapy at the RP2D(s) in Part D | Average of 6 months | Time to response (TTR) according to RECIST v1.1 |
| Secondary | Evaluate additional measures of efficacy of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy at the RP2D(s) in Part C | Average of 6 months | Duration of response (DoR) according to RECIST v1.1 |
| Secondary | Evaluate additional measures of efficacy of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy at the RP2D(s) in Part C | Average of 6 months | Disease control rate (DCR) according to RECIST v1.1 |
| Secondary | Evaluate additional measures of efficacy of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy at the RP2D(s) in Part C | Average of 6 months | Progression free survival (PFS) according to RECIST v1.1 |
| Secondary | Evaluate Safety of ETX-929 monotherapy in Part A and C, and and ETX-929 plus cetuximab combination therapy at the RP2Ds in Part B and Part D | Average of 6 months | Incidence of adverse events graded according to CTCAE v5.0 |
| Secondary | Evaluate Tolerability of ETX-929 monotherapy in Part A and C, and ETX-929 plus cetuximab combination therapy at the RP2Ds in Part B and Part D | Average of 6 months | Incidence of adverse events graded according to CTCAE v5.0 |
| Secondary | Characterize the PK of ETX-929 using population PK modeling | Average of 6 months | Plasma concentrations |
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.
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GET https://conductscience.org/api/trials/v1/NCT07912593/registered