Clinical trial NCT05369286: A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Combination With Toripalimab in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Maxinovel Pty., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: DLTs
timeFrame: 21 days
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 24 months
Secondary outcomes:
measure: Subsequent clinical recommended dose
timeFrame: 12 months
measure: Cmax
timeFrame: Approximately 6 months
measure: Tmax
timeFrame: Approximately 6 months
measure: AUC
timeFrame: Approximately 6 months
measure: T1/2
timeFrame: Approximately 6 months
measure: The blood concentration of toripalimab
timeFrame: Approximately 6 months
measure: ADA
timeFrame: 6 months
measure: The efficacy end points: ORR、DCR，PFS，DOR，OS
timeFrame: 24 months
measure: the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Institute of The Sixth Affiliated Hospital Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Institute of The Sixth Affiliated Hospital Sun Yat-sen University
name: xiangen MD Lu, Ph.D
role: STUDY_CHAIR
References: