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

ConditionsDynamic Tumor Resistance Metastatic Colorectal Cancer

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

SOC (Standard of care)
Other intervention
Blood draws, biopsies, samples and MRI.
Bevacizumab
Drug
Given by IV
Cetuximab
Drug
Given by Iv
Panitumumab
Drug
Given by Iv
FOLFIRI
Drug
Given by Iv
FOLFOX
Drug
Given by Iv
Encorafenib
Drug
Given by po
Adagrasib
Drug
Given by Po
Trifluridine/tipiracil (TAS-102)
Drug
Given by po
Trastuzumab deruxtecan
Drug
Given by IV
Tucatinib
Drug
Given by po
Sotorasib
Drug
Given by po

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: ASCEND-CRC Sample CollectionExperimental treatment 12 interventions

Trial outcomes

Primary outcomes

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

Time frame

Through study completion; an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: