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

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05130021
• Other study ID #: MAX-40279-005
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 31, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2021
• Source: Maxinovel Pty., Ltd.
• Contact: Hanying Bao, MD,Ph.D
• Phone: +86-021-51370693
• Email: hybao[@]maxinovel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: October 31, 2023
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• MAX-40279-01
MAX-40279-01 50mg/70mg
• regorafenib
regorafenib

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Maxinovel Pty., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate (DCR)[Part 1]		Through study Part 1 completion, an average of 6 months
Primary	progress free survival(PFS)[Part 2]		Through study Part 1 completion, an average of 6 months
Secondary	Tmax	Time to maximum plasma concentration	Approximately 6 months
Secondary	Cmax	Maximum plasma drug concentration	Approximately 6 months
Secondary	AUC	Area under the time-concentration curve	Approximately 6 months
Secondary	Objective response rate (ORR)		6 months (anticipated)
Secondary	overall survival (OS)		24 months
Secondary	Safety and tolerability assessed by incidence and severity of adverse events		24 months