ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

June 9, 2026 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Scott Kopetz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility Criteria

  • The participant has a histologically or cytologically confirmed diagnosis of colorectal cancer.
  • Confirmation of non-MSI-H/pMMR status.
  • Tumor that is measurable as per RECIST v1.1 and biopsy able, defined as lesion/tumor that can be biopsied without undue risk.
  • Age ≥ 18 years.
  • ECOG performance status 0-2.
  • Due to the potential teratogenic effect of chemotherapy, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen (Refer to Pregnancy Assessment Policy MD Anderson Institutional

Policy # CLN1114). This includes all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:

  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.

  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

    • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen.
    • The participant is willing and able to sign the informed consent in compliance with protocol requirements, including mandatory biopsies.

Exclusion Criteria

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASCEND-CRC Sample Collection
Standard of care
Drug: Bevacizumab
Given by IV
Other: SOC (Standard of care)
Blood draws, biopsies, samples and MRI.
Drug: Cetuximab
Given by Iv
Drug: Panitumumab
Given by Iv
Drug: FOLFIRI
Given by Iv
Drug: FOLFOX
Given by Iv
Drug: Encorafenib
Given by po
Drug: Adagrasib
Given by Po
Drug: Trifluridine/tipiracil (TAS-102)
Given by po
Drug: Trastuzumab deruxtecan
Given by IV
Drug: Tucatinib
Given by po
Drug: Sotorasib
Given by po

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Scott Kopetz, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

November 14, 2027

Study Completion (Estimated)

November 14, 2029

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-1634
  • NCI-2025-09705 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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