A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

NCT05416749 | Suspended Phase 1

• 1 other identifier: 8MW2311-2022-CP101
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 3

Brief Summary

This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• AEs

  All the adverse events

  Up to 28 days post last dose

• ORR

  Objective Response Rate

  Up to 24 months

Secondary Outcomes (13)

• BOR

  Up to 24 months

• DCR

  Up to 24 months

• CBR

  Up to 24 months

• PFS

  Up to 24 months

• DoR

  Up to 24 months

Study Arms (1)

8MW2311

EXPERIMENTAL

Drug: 8MW2311

Interventions

8MW2311 DRUG

All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.

8MW2311

Eligibility Criteria

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

You may qualify if:

• Male or female, aged≥18 years old;
• Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
• Subjects must have measurable disease according to RECIST (version 1.1)；
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
• Life expectancy \>3 months;
• Adequate organ performance based on laboratory blood tests;
• Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy；
• Ability to understand and the willingness to sign a written informed consent document；

You may not qualify if:

• History of other malignancy within 3 years before the first dose of study drug.
• History of IL-2 or IL-2 analogues anticancer therapy.
• Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.
• Major surgery within 28 days prior to first dose of study drug.
• Any live vaccines within 28 days before first dose of study drug or during the study.
• Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
• Toxicity related to preexisting treatment ≥Grade 2.
• Central nervous system metastasis and/or cancerous meningitis.
• Inadequately controlled body cavity effusions.
• Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
• Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
• Clinically significant cardiac or cerebrovascular disease.
• Use of any investigational drug within 28 days prior to the first dose of study drug.
• Known sensitivity to any of the ingredients of the study drug.
• Known active hepatitis B or C infection, or other serious infection.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (3)

The first affiliated hospital of bengbu medicial college

Bengbu, Anhui, China

Location

Hunan cancer hospital

Changsha, Hunan, China

Location

Jian Zhang

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Jian Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 13, 2022
• Study Start: August 5, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)