A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer

A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer

This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: MAX-40279-01; Drug: regorafenib

Detailed Description

This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanhong Y Deng, Dr; Phone Number: +8613925106525; Email: 13925106525@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Sixth Affiliated Hospital of Sun Yat-Sen University
      • Contact: Yanhong Deng, Dr; Phone Number: +86 13925106525; Email: 13925106525@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival >3 months.
5. previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved.
6. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization.
3. Inadequate organ or bone marrow function.
4. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
5. Pregnant or breast-feeding woman.
6. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1;50mg	Drug: MAX-40279-01; MAX-40279-01 50mg/70mg
Experimental: Part 1;70mg	Drug: MAX-40279-01; MAX-40279-01 50mg/70mg
Experimental: Part 2;MAX-40279-01	Drug: MAX-40279-01; MAX-40279-01 50mg/70mg
Experimental: Part 2;regorafenib	Drug: regorafenib; regorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease control rate (DCR)[Part 1]	Through study Part 1 completion, an average of 6 months
progress free survival(PFS)[Part 2]	Through study Part 1 completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival (OS)		24 months
Tmax	Time to maximum plasma concentration	Approximately 6 months
Cmax	Maximum plasma drug concentration	Approximately 6 months
AUC	Area under the time-concentration curve	Approximately 6 months
Objective response rate (ORR)		6 months (anticipated)
Safety and tolerability assessed by incidence and severity of adverse events		24 months

Collaborators and Investigators

• Sponsor: Maxinovel Pty., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2022
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: metastatic colorectal cancer; pretreated
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MAX-40279-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No