A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer

NCT05513742 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CTX-009-003
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief Summary

This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer. A Simon Two-Stage adaptive design will enroll approximately 37 patients into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled.

Conditions

Metastatic Colorectal Cancer; Colon Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1

  From Cycle 1 Day 1 (C1D1) to treatment discontinuation for any reason, average of 6 months

Secondary Outcomes (5)

• Disease Control Rate

  From C1D1 to treatment discontinuation for any reason, average of 6 months

• Duration of Response

  From first confirmed CR or PR to confirmed PD, average of 6 months

• Progression Free Survival

  From C1D1 to first documented objective PD or death if PD does not occur, average of 6 months

• Overall Survival

  From C1D1 to death from any cause, average of 9 months

• Incidence of Treatment Emergent Adverse Events (TEAEs) and changes in clinical abnormalities

  From C1D1 to 60 days after the last dose of study treatment, average of 7 months

Study Arms (1)

CTX-009 Treatment

EXPERIMENTAL

Drug: CTX-009

Interventions

CTX-009 DRUG

IV infusion administered on day 1 and 15 of every 28-day cycle

CTX-009 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically or cytologically confirmed metastatic or recurrent colorectal cancers
• The primary tumor must have been resected \> 3 months prior to planned C1D1.
• Patients who experienced progressive disease or relapse after receiving two or three prior lines of systemic therapy in the locally advanced or metastatic setting. Prior lines of systemic treatment must have included at least one fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab containing chemotherapy regimen (in any combination and may have been administered in the neoadjuvant setting).
• Patients whose tumor is not right sided and RAS wild type must also have received an anti-epidermal growth factor receptor (EGFR) therapy.
• Patients with tumors harboring mutations or other alterations for which there are available targeted therapies (e.g. BRAF V600E, HER2-positive, MSI-H/dMMR, etc.) must have also received the relevant approved targeted therapies.
• If patient received peri-operative treatment (neoadjuvant and/or adjuvant), please consult the Sponsor Medical Monitor for review of prior treatment lines.
• At least one lesion measurable as defined by RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Predicted life expectancy of at least 12 weeks
• Adequate hepatic and renal function within 14 days of C1D1 as described below:
• Total bilirubin ≤ 1.5 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 3.0 X ULN (≤ 5x ULN in case of hepatic metastasis)
• Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault estimated creatinine clearance
• Urine protein ≤ 1+ by spot urinalysis (or, if \> 1+ then 24 hr urine protein \<1.0 g/24 hr)

You may not qualify if:

• From the time point of signed informed consent,
• Less than 4 weeks have elapsed since patients had a surgery or major procedure
• Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy
• Prior to planned C1D1,
• Less than 4 weeks have elapsed since patients had chemotherapy or targeted therapy for colorectal cancer
• Less than 4 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment
• Congestive heart failure that corresponds to Class II or a higher class under New York Heart Association (NYHA) classification or less than 50% of left ventricular ejection fraction (LVEF)
• Uncontrolled hypertension (systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\] \> 140/90 mmHg) (e.g., patient with SBP/DBP \> 140/90 mmHg despite the best care including anti-hypertensive medications)
• Patients with a history of hypertensive crisis or pre-existing hypertensive encephalopathy
• Pulmonary hypertension
• Myocardial infarction
• Uncontrolled arrhythmia
• Unstable angina
• Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product
• Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving)

Sponsors & Collaborators

• Compass Therapeutics: lead

Study Sites (7)

Genesis Cancer and Blood Institute

Hot Springs, Arkansas, 71913, United States

Location

Florida Cancer Specialists & Research Institute - South

Fort Myers, Florida, 33916, United States

Location

Florida Cancer Specialists & Research Institute - North

St. Petersburg, Florida, 33705, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Minori Rosales, MD, PhD

  Compass Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Approximately 37 patients will be enrolled into Stage 1, and if criteria are met to move to Stage 2, an additional 47 patients will be enrolled, for a total of approximately 84 patients.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: December 8, 2022
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 6, 2026

Record last verified: 2025-06

Locations

US (7)