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

Solid Tumors Clinical Trial

Official title:

Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416749
• Other study ID #: 8MW2311-2022-CP101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 5, 2022
• Est. completion date: March 2026

Study information

• Verified date: June 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: Jian Zhang
• Phone: 021-64175590
• Email: syner2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, aged=18 years old;

2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor;

3. Subjects must have measurable disease according to RECIST (version 1.1);

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;

5. Life expectancy >3 months;

6. Adequate organ performance based on laboratory blood tests;

7. 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;

8. Ability to understand and the willingness to sign a written informed consent document;

Exclusion Criteria:

1. History of other malignancy within 3 years before the first dose of study drug.

2. History of IL-2 or IL-2 analogues anticancer therapy.

3. 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.

4. Major surgery within 28 days prior to first dose of study drug.

5. Any live vaccines within 28 days before first dose of study drug or during the study.

6. Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.

7. Toxicity related to preexisting treatment =Grade 2.

8. Central nervous system metastasis and/or cancerous meningitis.

9. Inadequately controlled body cavity effusions.

10. Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.

11. Active autoimmune disease, or autoimmune diseases history with recurrence possibility.

12. Clinically significant cardiac or cerebrovascular disease.

13. Use of any investigational drug within 28 days prior to the first dose of study drug.

14. Known sensitivity to any of the ingredients of the study drug.

15. Known active hepatitis B or C infection, or other serious infection.

16. History of drug abuse or drug addiction.

17. Pregnancy or lactation.

18. Other disease or condition which may put the subject at significant risk.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
China	The first affiliated hospital of bengbu medicial college	Bengbu	Anhui
China	Hunan cancer hospital	Changsha	Hunan
China	Jian Zhang	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs	All the adverse events	Up to 28 days post last dose
Primary	ORR	Objective Response Rate	Up to 24 months
Secondary	BOR	Best of Response	Up to 24 months
Secondary	DCR	Disease Control Rate	Up to 24 months
Secondary	CBR	Clinical Benefit Rate	Up to 24 months
Secondary	PFS	Progression-Free Survival	Up to 24 months
Secondary	DoR	Duration of Remission	Up to 24 months
Secondary	TTR	Time to Response	Up to 24 months
Secondary	TTP	Time to Progression	Up to 24 months
Secondary	OS	Overall Survival	Up to 24 months
Secondary	PK Parameter AUC	The area under the curve (AUC)	Up to 24 months
Secondary	PK Parameter Cmax	Maximum concentration (Cmax)	Up to 24 months
Secondary	PK Parameter Tmax	Time at which maximum concentration(Tmax)	Up to 24 months
Secondary	PK Parameter T1/2	The half life(T1/2)	Up to 24 months
Secondary	Incidence of ADA	Incidence of Anti-Drug Antibody (ADA)	Up to 24 months