Trial · NCT07912593
A KRAS Inhibitor in Participants With Advanced Solid Tumors
NCT07912593, Phase 1, Phase 2, Recruiting, Ensem Therapeutics
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A KRAS Inhibitor in Participants With Advanced Solid Tumors. Trials, record NCT07912593. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912593
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A KRAS Inhibitor in Participants With Advanced Solid Tumors
- NCT number
- NCT07912593
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 320 participants, estimated
- Lead sponsor
- Ensem Therapeutics
- Conditions
- Metastatic Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Non-squamous, Non-Small Cell Lung Cancer, Endometrial Adenocarcinoma, Ovarian Adenocarcinoma, Primary Peritoneal Carcinoma
- Interventions
- ETX-929 dose escalation, ETX-929 dose escalation in combination with cetuximab
- First posted
- 2026-11-03
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07912593
GET https://conductscience.org/api/trials/v1/NCT07912593/registered