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

NCT05369286 | Unknown Phase 1

• 1 other identifier: MAX-40279-008
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Subsequent clinical recommended dose

  12 months

• Cmax

  Approximately 6 months

• Tmax

  Approximately 6 months

• AUC

  Approximately 6 months

• T1/2

  Approximately 6 months

Study Arms (5)

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

EXPERIMENTAL

"MAX-40279-01" and "toripalimab"

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

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

EXPERIMENTAL

"MAX-40279-01" and "toripalimab"

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

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

EXPERIMENTAL

"MAX-40279-01" and "toripalimab"

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

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

EXPERIMENTAL

"MAX-40279-01" and "toripalimab"

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

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

EXPERIMENTAL

"MAX-40279-01" and "toripalimab"

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

Interventions

"MAX-40279-01" and "Toripalimab" DRUG

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

dose level 1 of max-40279 combined dose level 1 of toripalimab; dose level 2 of max-40279 combined dose level 1 of toripalimab; dose level 2 of max-40279 combined dose level 2 of toripalimab; dose level 3 of max-40279 combined dose level 2 of toripalimab; recommend dose of max-40279 combined recommend dose level of toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and/or females over age 18
• Histologically and/or cytologically documented local advanced or metastatic solid tumor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival \>3 months.
• Signed informed consent form.

You may not qualify if:

• Known uncontrolled or symptomatic central nervous system metastatic disease.
• Inadequate organ or bone marrow function.
• Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
• Pregnant or breast-feeding woman.
• Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments.

Sponsors & Collaborators

• Maxinovel Pty., Ltd.: lead

Study Sites (1)

Institute of The Sixth Affiliated Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• xiangen MD Lu, Ph.D

  Institute of The Sixth Affiliated Hospital Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Hanying MD Bao, Ph.D

CONTACT

+86-021-51370693; hybao@maxinovel.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 11, 2022
• Study Start: April 11, 2022
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)