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

Phase 2

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: MAX-40279-01; Drug: regorafenib

• Registration Number: NCT05130021
• Lead Sponsor: Maxinovel Pty., Ltd.

Brief Summary

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

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 Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-06
• Study Start: 2022-01-31
• Primary Completion: 2022-05-30
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1;50mg	MAX-40279-01	-
Part 1;70mg	MAX-40279-01	-
Part 2;MAX-40279-01	MAX-40279-01	-
Part 2;regorafenib	regorafenib	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

The Sixth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China