A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors

Maxinovel

Status and phase: Unknown; Phase 1

Conditions: Solid Tumor

Treatments: Drug: "MAX-40279-01" and "Toripalimab"

Study type: Interventional

Funder types: Industry

Identifiers

NCT05369286

MAX-40279-008

Details and patient eligibility

About

This include two parts, part 1 is a dose escalation study and part 2 is a dose expansion study.

Full description

This study is a study of Max-40279-01 in combination with toripalimab in patients with advanced solid tumors. This study includes two Parts, the Part 1 will assess the safety and efficacy of the preset several dose levels of Max-40279-01 and toripalimab, and recommend a dose level of Max-40279-01 combined toripalimab for stage 2. The part 2 is designed to study the efficacy and safety of max-40279-01 combined toripalimab in advanced solid tumors or certain specific tumors.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 75 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 solid tumor.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival >3 months.
5. 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.5.0) 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 5 patient groups

dose level 1 of max-40279 combined dose level 1 of toripalimab

Experimental group

Description:

"MAX-40279-01" and "toripalimab"

Treatment:

Drug: "MAX-40279-01" and "Toripalimab"

dose level 2 of max-40279 combined dose level 1 of toripalimab

Experimental group

Description:

"MAX-40279-01" and "toripalimab"

Treatment:

Drug: "MAX-40279-01" and "Toripalimab"

dose level 2 of max-40279 combined dose level 2 of toripalimab

Experimental group

Description:

"MAX-40279-01" and "toripalimab"

Treatment:

Drug: "MAX-40279-01" and "Toripalimab"

dose level 3 of max-40279 combined dose level 2 of toripalimab

Experimental group

Description:

"MAX-40279-01" and "toripalimab"

Treatment:

Drug: "MAX-40279-01" and "Toripalimab"

recommend dose of max-40279 combined recommend dose level of toripalimab

Experimental group

Description:

"MAX-40279-01" and "toripalimab"

Treatment:

Drug: "MAX-40279-01" and "Toripalimab"