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

A Phase 1 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Combination With Toripalimab in Patients With Advanced Solid Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: "MAX-40279-01" and "Toripalimab"

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hanying MD Bao, Ph.D; Phone Number: +86-021-51370693; Email: hybao@maxinovel.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Institute of The Sixth Affiliated Hospital Sun Yat-sen University
      • Contact: xiangen Lu; Phone Number: 020-38379764; Email: zslyllb@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: dose level 1 of max-40279 combined dose level 1 of toripalimab; "MAX-40279-01" and "toripalimab"	Drug: "MAX-40279-01" and "Toripalimab"; "MAX-40279-01"combined with "Toripalimab"
EXPERIMENTAL: dose level 2 of max-40279 combined dose level 1 of toripalimab; "MAX-40279-01" and "toripalimab"	Drug: "MAX-40279-01" and "Toripalimab"; "MAX-40279-01"combined with "Toripalimab"
EXPERIMENTAL: dose level 2 of max-40279 combined dose level 2 of toripalimab; "MAX-40279-01" and "toripalimab"	Drug: "MAX-40279-01" and "Toripalimab"; "MAX-40279-01"combined with "Toripalimab"
EXPERIMENTAL: dose level 3 of max-40279 combined dose level 2 of toripalimab; "MAX-40279-01" and "toripalimab"	Drug: "MAX-40279-01" and "Toripalimab"; "MAX-40279-01"combined with "Toripalimab"
EXPERIMENTAL: recommend dose of max-40279 combined recommend dose level of toripalimab; "MAX-40279-01" and "toripalimab"	Drug: "MAX-40279-01" and "Toripalimab"; "MAX-40279-01"combined with "Toripalimab"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLTs	Dose limiting toxicity	21 days
Incidence of Treatment-Emergent Adverse Events	Safety and tolerability assessed by incidence and severity of adverse events	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subsequent clinical recommended dose	Subsequent clinical recommended dose	12 months
Cmax	Maximum plasma drug concentration of Max-40279	Approximately 6 months
Tmax	Time to maximum plasma concentration of Max-40279	Approximately 6 months
AUC	Area under the time-concentration curve of Max-40279	Approximately 6 months
T1/2	Half-life of Max-40279	Approximately 6 months
The blood concentration of toripalimab	The blood concentration of toripalimab	Approximately 6 months
ADA	Anti-drug antibody of toripalimab	6 months
The efficacy end points: ORR、DCR，PFS，DOR，OS	Objective response rate,Disease control rate,Progression-free survival,Duration of response,Overall survival	24 months
the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors	the correlation of efficacy and the expression level and mutations of FGFR1OP2, its related proteins and inflammatory factors	24 months

Collaborators and Investigators

• Sponsor: Maxinovel Pty., Ltd.
• Investigators: Study Chair: xiangen MD Lu, Ph.D, Institute of The Sixth Affiliated Hospital Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2022
• Primary Completion (ANTICIPATED): May 31, 2023
• Study Completion (ANTICIPATED): August 31, 2023

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (ACTUAL): May 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MAX-40279-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No