NCT07318389

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
42mo left

Started Jun 2026

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 10, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2029

Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

December 30, 2025

Last Update Submit

February 25, 2026

Conditions

Dynamic Tumor ResistanceMetastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion; an average of 1 year

Study Arms (1)

ASCEND-CRC Sample Collection

EXPERIMENTAL

Standard of care

Other: SOC (Standard of care)Drug: BevacizumabDrug: CetuximabDrug: PanitumumabDrug: FOLFIRIDrug: FOLFOXDrug: EncorafenibDrug: AdagrasibDrug: Trifluridine/tipiracil (TAS-102)Drug: Trastuzumab deruxtecanDrug: TucatinibDrug: Sotorasib

Interventions

SOC (Standard of care)OTHER

Blood draws, biopsies, samples and MRI.

ASCEND-CRC Sample Collection
BevacizumabDRUG

Given by IV

ASCEND-CRC Sample Collection
CetuximabDRUG

Given by Iv

ASCEND-CRC Sample Collection
PanitumumabDRUG

Given by Iv

ASCEND-CRC Sample Collection
FOLFIRIDRUG

Given by Iv

ASCEND-CRC Sample Collection
FOLFOXDRUG

Given by Iv

ASCEND-CRC Sample Collection
EncorafenibDRUG

Given by po

ASCEND-CRC Sample Collection
AdagrasibDRUG

Given by Po

ASCEND-CRC Sample Collection
Trifluridine/tipiracil (TAS-102)DRUG

Given by po

ASCEND-CRC Sample Collection
Trastuzumab deruxtecanDRUG

Given by IV

ASCEND-CRC Sample Collection
TucatinibDRUG

Given by po

ASCEND-CRC Sample Collection
SotorasibDRUG

Given by po

ASCEND-CRC Sample Collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Standard of CareBevacizumabCetuximabPanitumumabIFL protocolFolfox protocolencorafenibadagrasibTrifluridinetipiraciltrifluridine tipiracil drug combinationtrastuzumab deruxtecantucatinibsotorasib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Scott Kopetz, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Kopetz, MD

CONTACT

713-792-2828skopetz@mdanderson.org

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 6, 2026

Study Start (Estimated)

June 10, 2026

Primary Completion (Estimated)

November 14, 2027

Study Completion (Estimated)

November 14, 2029

Last Updated

February 27, 2026

Record last verified: 2026-01

Locations

US(1)