Clinical trial NCT05130021: A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer
Official title: A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer
pretreated
Lead sponsor: Maxinovel Pty., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease control rate (DCR)[Part 1]
timeFrame: Through study Part 1 completion, an average of 6 months
measure: progress free survival(PFS)[Part 2]
timeFrame: Through study Part 1 completion, an average of 6 months
Secondary outcomes:
measure: Tmax
timeFrame: Approximately 6 months
measure: Cmax
timeFrame: Approximately 6 months
measure: AUC
timeFrame: Approximately 6 months
measure: Objective response rate (ORR)
timeFrame: 6 months (anticipated)
measure: overall survival (OS)
timeFrame: 24 months
measure: Safety and tolerability assessed by incidence and severity of adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: