Dynamic Tumor ResistanceEarly Phase 1NCT07318389
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
A Early Phase 1 study testing Bevacizumab, Cetuximab and Panitumumab in people with Dynamic Tumor Resistance and Metastatic Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dynamic Tumor Resistance, Metastatic Colorectal Cancer
- What is being tested?
- Bevacizumab, Cetuximab and Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2026to 14 Nov 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy.
- Participants with concurrent or recent (less than 1 year before consent) malignancies that have the potential to interfere with the study safety and/or endpoint assessments will be excluded.
- Participants for whom there is an intent to proceed to curative therapy (i.e., resection) will be excluded.
- Participants who have undergone treatment with both oxaliplatin and irinotecan in the metastatic setting will be excluded. Treatment with oxaliplatin in the adjuvant setting with relapse within 6 months will be counted as treatment in the metastatic setting for the purpose of this criterium.
- For participants who have undergone treatment for metastatic disease, participants who have not progressed (clinically or radiographically) on the most recent therapy will be excluded.
- Concurrent participation in any other interventional trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Kopetz Scott, MD, 713-792-2828, skopetz@mdanderson.org
Scott Kopetz, MD
About this study
To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.
Read the detailed description
Primary Objectives
- To determine differences in PFS based on differential response markers in paired tissue biopsies (Part I).
- To improve progression-free survival with novel intervention strategies (Part II)
Secondary Objectives
- To collect serial tissue and blood biomarkers and efficacy data associated with standard of care or investigational therapy across multiple lines of therapy.
- To determine the overall response rate (ORR), and overall survival (OS) based on the presence of specific biomarkers or adaptive interventions.
- Being tested
- SOC (Standard of care), Bevacizumab, Cetuximab, Panitumumab, FOLFIRI
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC (Standard of care)Other
Blood draws, biopsies, samples and MRI.
BevacizumabDrug
Given by IV
CetuximabDrug
Given by Iv
PanitumumabDrug
Given by Iv
FOLFIRIDrug
Given by Iv
FOLFOXDrug
Given by Iv
EncorafenibDrug
Given by po
AdagrasibDrug
Given by Po
Trifluridine/tipiracil (TAS-102)Drug
Given by po
Trastuzumab deruxtecanDrug
Given by IV
TucatinibDrug
Given by po
SotorasibDrug
Given by po
| Study group | Role | What they receive |
|---|---|---|
| ASCEND-CRC Sample Collection | Experimental | Standard of care Receives: Other: SOC (Standard of care); Drug: Bevacizumab; Drug: Cetuximab; Drug: Panitumumab; Drug: FOLFIRI; Drug: FOLFOX; Drug: Encorafenib; Drug: Adagrasib; Drug: Trifluridine/tipiracil (TAS-102); Drug: Trastuzumab deruxtecan; Drug: Tucatinib; Drug: Sotorasib |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start22 Apr 2026
- Primary completion14 Nov 2027 (estimated)
- Study completion14 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic Tumor ResistanceStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Kopetz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318389
- Sponsor's protocol ID
- 2025-1634
- Other IDs
- NCI-2025-09705
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07318389
- Acronym / sponsor ID
- 2025-1634
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 14 Nov 2027 (estimated)
- Study completion
- 14 Nov 2029 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.
Detailed description
Primary Objectives
- To determine differences in PFS based on differential response markers in paired tissue biopsies (Part I).
- To improve progression-free survival with novel intervention strategies (Part II)
Secondary Objectives
- To collect serial tissue and blood biomarkers and efficacy data associated with standard of care or investigational therapy across multiple lines of therapy.
- To determine the overall response rate (ORR), and overall survival (OS) based on the presence of specific biomarkers or adaptive interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCEND-CRC Sample Collection | Experimental | Other: SOC (Standard of care), Drug: Bevacizumab, Drug: Cetuximab, Drug: Panitumumab, Drug: FOLFIRI, Drug: FOLFOX, Drug: Encorafenib, Drug: Adagrasib, Drug: Trifluridine/tipiracil (TAS-102), Drug: Trastuzumab deruxtecan, Drug: Tucatinib, Drug: SotorasibStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Pregnancy.
- Participants with concurrent or recent (less than 1 year before consent) malignancies that have the potential to interfere with the study safety and/or endpoint assessments will be excluded.
- Participants for whom there is an intent to proceed to curative therapy (i.e., resection) will be excluded.
- Participants who have undergone treatment with both oxaliplatin and irinotecan in the metastatic setting will be excluded. Treatment with oxaliplatin in the adjuvant setting with relapse within 6 months will be counted as treatment in the metastatic setting for the purpose of this criterium.
- For participants who have undergone treatment for metastatic disease, participants who have not progressed (clinically or radiographically) on the most recent therapy will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOC (Standard of care)Blood draws, biopsies, samples and MRI. | Other | ASCEND-CRC Sample Collection |
| BevacizumabGiven by IV | Drug | ASCEND-CRC Sample Collection |
| CetuximabGiven by Iv | Drug | ASCEND-CRC Sample Collection |
| PanitumumabGiven by Iv | Drug | ASCEND-CRC Sample Collection |
| FOLFIRIGiven by Iv | Drug | ASCEND-CRC Sample Collection |
| FOLFOXGiven by Iv | Drug | ASCEND-CRC Sample Collection |
| EncorafenibGiven by po | Drug | ASCEND-CRC Sample Collection |
| AdagrasibGiven by Po | Drug | ASCEND-CRC Sample Collection |
| Trifluridine/tipiracil (TAS-102)Given by po | Drug | ASCEND-CRC Sample Collection |
| Trastuzumab deruxtecanGiven by IV | Drug | ASCEND-CRC Sample Collection |
| TucatinibGiven by po | Drug | ASCEND-CRC Sample Collection |
| SotorasibGiven by po | Drug | ASCEND-CRC Sample Collection |
Primary outcome
safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Kopetz, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bevacizumab, Cetuximab and Panitumumab in people with Dynamic Tumor Resistance and Metastatic Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Kopetz, MD (713-792-2828, skopetz@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.