This early phase I trial tests the safety, side effects, and how well certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease in patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Approximately 60–70% of patients with metastatic colorectal cancer (mCRC) respond to first-line therapy, though a substantial proportion will ultimately experience disease progression despite initial response. Key barriers blocking the potential efficacy of alternative targeted therapies are the inability to identify and personalize the therapeutic approach in all lines of therapy, as tumors evolve and develop resistance mechanisms, and biomarkers identified to date have been based on archival material traditionally collected at a single time point prior to treatment with first line therapy and/or do not represent the metastatic disease site or tumor evolution. Using a biomarker-based prospective biopsies, paired serial blood samples, and patient outcomes throughout first-, second-, and third line standard-of-care (SOC) therapy or experimental therapies may help create a new personalized interventional approach to treat patients with metastatic colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07318389.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Edmund Scott Kopetz
Phone: 713-792-2828
PRIMARY OBJECTIVES:
I. To determine differences in progression-free survival (PFS) based on differential response markers in paired tissue biopsies. (Part I)
II. To improve progression-free survival with novel intervention strategies. (Part II)
SECONDARY OBJECTIVES:
I. To collect serial tissue and blood biomarkers and efficacy data associated with standard of care or investigational therapy across multiple lines of therapy.
II. To determine the overall response rate (ORR), and overall survival (OS) based on the presence of specific biomarkers or adaptive interventions.
EXPLORATORY OBJECTIVES:
I. Correlate multidimensional tumor measurements from serial tissue biopsies and peripheral blood with patient outcomes.
II. Identify patterns of biomarkers associated with response to specific therapies and combinations.
OUTLINE:
PART I:
HUB PROTOCOL: At the discretion of the treating physician, patients may receive any of the following SOC 1st, 2nd, and/or 3rd lines of treatment in the absence of disease progression or unacceptable toxicity: Bevacizumab plus oxaliplatin, leucovorin, 5-fluorouracil (FOLFOX); 2) bevacizumab plus irinotecan, leucovorin, 5-fluorouracil (FOLFIRI); 3) bevacizumab plus 5-fluorouracil, leucovorin, oxaliplatin, irinotecan (FOLFOXIRI); 4) bevacizumab plus trifluridine/tipiracil; 5) cetuximab/panitumumab plus FOLFOX/FOLFIRI; 6) bevacizumab plus FOLFOX/FOLFIRI; 7) bevacizumab plus FOLFOXIRI; 8) cetuximab/panitumumab plus encorafenib plus FOLFOX; 9) cetuximab/panitumumab plus encorafenib; 10) cetuximab/panitumumab plus adagrasib; OR 11) trastuzumab plus pertuzumab or tucatinib or trastuzumab deruxtecan. Patients undergo blood and saliva sample collection, tissue biopsy, computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.
At the time of disease progression, patients may enroll onto SUB-PROTOCOL A.
SUB-PROTOCOL A: At the discretion of the treating physician, patients may receive any of the SOC 2nd and/or 3rd lines of treatment regimen(s) as described above in HUB PROTOCOL in the absence of disease progression or unacceptable toxicity. Patients also undergo blood and saliva sample collection, tissue biopsy, CT or MRI throughout the study.
After completion of study treatment, patients are followed up at 30 days and then up to 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorEdmund Scott Kopetz
