A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

NCT06947226 | Not Yet Recruiting Phase 1

• 1 other identifier: 9MW2821-CP201
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of AE/SAE (phase Ib)

  Adverse event (AE), serious adverse event (SAE)

  Up to approximately 24 months

• Objective Response Rate, ORR (phase II)

  The proportion of participants with complete response (CR) or partial response (PR)

  Up to approximately 24 months

Secondary Outcomes (12)

• Duration of Response, DOR

  Up to approximately 24 months

• Time To Response, TTR

  Up to approximately 24 months

• Disease Control Rate, DCR

  Up to approximately 24 months

• Progression-Free Survival, PFS

  Up to approximately 24 months

• Overall Survival, OS

  Up to approximately 24 months

Study Arms (2)

Combination Cohort

EXPERIMENTAL

Subjects will receive intravenous (IV) infusion of 9MW2821 + other anticancer therapy as per protocol

Drug: 9MW2821; Drug: Other anti-cancer therapy

Single agent Cohort

EXPERIMENTAL

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Drug: 9MW2821

Interventions

9MW2821 DRUG

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Combination Cohort; Single agent Cohort

Other anti-cancer therapy DRUG

Subjects will receive other anticancer therapy as per protocol

Combination Cohort

Eligibility Criteria

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

You may qualify if:

• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• Male or female subjects aged 18 to 75 years (including 18 and 75 years).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
• Adequate tumor tissues submitted for test.
• Life expectancy of ≥ 12 weeks.
• Subjects must have measurable disease according to RECIST (version 1.1).
• Adequate organ functions.
• Sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy.
• Subjects are willing to follow study procedures.

You may not qualify if:

• History of another malignancy within 3 years before the first dose of study drug.
• Ongoing clinically significant toxicities related to prior treatment.
• Grade ≥ 2 peripheral neuropathy.
• Severe or uncontrolled gastrointestinal diseases.
• Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
• Experienced clinically significant bleeding or had a clear bleeding tendency.
• Central nervous system (CNS) metastasis and/or malignant meningitis.
• Clinically significant pleural, abdominal, or pericardial effusion.
• Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;
• Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
• Pregnant and lactating women.
• Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 451161, China

Location

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang

CONTACT

13938244776; fengw010@163.com

Study Design

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

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)