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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2023-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

"MAX-40279-01"combined with "Toripalimab"

Interventions

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"MAX-40279-01" and "Toripalimab"

"MAX-40279-01"combined with "Toripalimab"

Intervention Type DRUG

Eligibility Criteria

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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.
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No