A Phase 1/2 interventional study of ETX-929 dose escalation and ETX-929 dose escalation in combination with cetuximab in Metastatic Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC) and Non-squamous, Non-Small Cell Lung Cancer, sponsored by Ensem Therapeutics. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Ensem Therapeutics · Phase 1/2, Interventional, and Treatment
Among 2,338 studies in Colorectal Neoplasms with a site in United States — 422 open to participants now, 630 under way, 30 of them phase 3. Colorectal Neoplasms · United States.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 410th largest by planned enrollment of the 1,931 interventional ones, is one of 117 that started in 2026, is one of 266 in phase 1/2, reaches primary completion later than 474 of the 627 other live ones, and was the 2,336th registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 320 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →422 of the 2,338 studies in Colorectal Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →2,338 studies; the count open now beside each. This study's row is marked.
First in 1981; this study’s year is marked. 117 started in 2026.
Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,562 that completed or were terminated, 548 (35%) have results posted.
885 of 2,338 have an industry lead sponsor. The 10 most frequent:
Ensem Therapeutics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Ensem Therapeutics has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
229 of the studies in Colorectal Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05141721Phase 3Seattle Project CorporationA Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | 2027-03 |
| NCT04428905Phase 3City of Hope Medical CenterSelf-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer | 2027-03-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT01349881Phase 3SWOG Cancer Research NetworkS0820, Adenoma and Second Primary Prevention Trial | 2027-09-15 |
| NCT03796884Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | 2026-11 |
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, from their registry updates:
This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
Part A will evaluate escalating doses of ETX-929 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-929 as combination therapy with fixed dose cetuximab in participants. Part C and Part D will expand enrollment of ETX-929 as monotherapy and in combination with cetuximab at the recommended doses from escalation.
Each study part will include a 28-day screening period, followed by treatment with ETX-929 monotherapy or combination therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part A is a dose escalation monotherapy of ETX-929 in advanced solid tumors with KRAS alterations.
Drug: ETX-929 dose escalation
Part B is a dose escalation combination therapy in advanced solid tumors with KRAS alterations. The study treatment will be ETX-929, a pan-KRAS inhibitor, in combination with cetuximab at a fixed dose.
Drug: ETX-929 dose escalation in combination with cetuximab
Part C will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.
Drug: ETX-929 dose escalation
Part D will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.
Drug: ETX-929 dose escalation in combination with cetuximab
ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule that will be taken once per day in 21-day cycles, to evaluate escalating dose levels.
ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule. ETX-929 will be taken in combination with cetuximab in 28-day cycles, to evaluate escalating dose levels. EXT-929 is an oral capsule that will be taken once per day. Cetuximab will be administered intravenously every two weeks.
Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B
Proportion of participants who experience at least 1 Dose Limiting Toxicity (DLT)
Time frame: First Cycle (21 days in Part A and 28 days in Part B)
Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B
Incidence of AEs, treatment discontinuations due to AEs, changes from baseline in laboratory assessments, ECGs and vital signs
Time frame: Average of 6 months
Select the Recommended Phase 2 Dose(s) (RP2D)
Safety Parameters as described for primary outcomes
Time frame: Average of 6 months
Evaluate efficacy of ETX-929 monotherapy and ETX-929 in combination with cetuximab at the RP2D(s) in Part B and Part D
ORR according to RECIST v1.1
Time frame: Average of 6 months
Characterize the Cmax (PK) of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B
Maximum observed plasma concentration (Cmax) of ETX-929
Time frame: First treatment cycle (21 day-cycles in Part A and 28-day cycles in Part B)
Characterize the Tmax (PK) of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B
Calculated time to reach maximum observed plasma concentration of ETX-929
Time frame: First treatment cycle (21 day-cycles in Part A and 28-day cycles in Part B)
Characterize the AUC (PK) of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B
Calculated area under the plasma concentration curve (AUC) of ETX-929
Time frame: First treatment cycle (21 day-cycles in Part A and 28-day cycles in Part B)
Assess preliminary efficacy of ETX-929 monotherapy in Part A and ETX-636 plus cetuximab combination therapy in Part B
Objective response rate (ORR) and clinical benefit rate (CBR) based on RECIST v1.1
Time frame: Average of 6 months
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
Time to response (TTR) according to RECIST v1.1
Time frame: Average of 6 months
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
Duration of response (DoR) according to RECIST v1.1
Time frame: Average of 6 months
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
Disease control rate (DCR) according to RECIST v1.1
Time frame: Average of 6 months
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
Progression free survival (PFS) according to RECIST v1.1
Time frame: Average of 6 months
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
Incidence of adverse events graded according to CTCAE v5.0
Time frame: Average of 6 months
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
Incidence of adverse events graded according to CTCAE v5.0
Time frame: Average of 6 months
Characterize the PK of ETX-929 using population PK modeling
Plasma concentrations
Time frame: Average of 6 months
Started Oct 2026 (actual). Primary completion is estimated for Oct 2028, 24 months after the start.
Of 158 industry-sponsored phase 1/2 interventional studies under Colorectal Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 24 months is below that.
Counting every sponsor, half of 260 studies reached it within 59 months; a quarter within 36 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Ensem Therapeutics