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

Maxinovel

Status and phase: Unknown; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: MAX-40279-01; Drug: regorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05130021

MAX-40279-005

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 4 patient groups

Part 1;50mg

Experimental group

Treatment:

Drug: MAX-40279-01

Part 1;70mg

Experimental group

Treatment:

Drug: MAX-40279-01

Part 2;MAX-40279-01

Experimental group

Treatment:

Drug: MAX-40279-01

Part 2;regorafenib

Experimental group

Treatment:

Drug: regorafenib