6MW3511 in Patients With Advanced Solid Tumor

Solid Tumors Clinical Trial

Official title:

A Phase I/II, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of 6MW3511 in Patients With Advanced Solid Tumor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05524194
• Other study ID #: 6MW3511-2022-CP101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2022
• Est. completion date: September 2024

Study information

• Verified date: August 2022
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.

Description:

This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 272
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. In dose-escalation cohorts, histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.In the dose-expansion cohorts , histologically or cytologically confirmed selected advanced solid tumors (to be determined).

2. Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive).

3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

Exclusion Criteria:

1. History of other malignant tumors within 3 years, except for the tumors that had been cured.

2. Symptomatic or active central nervous system metastasis.

3. Patients with active autoimmune disease.

4. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.

5. Patients previously treated with PD-(L)1/ TGF-ß antibody or combined PD-(L)1 with TGF-ß antibody.

6. Pregnant or breast feeding.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• Intravenous Infusion
Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a Dose Limiting Toxicity (DLT)	DLTs will be assessed during the first 3 weeks of treatment for dose-escalation phase.	Up to Week 3
Primary	Number of participants with adverse events (AEs)	Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs.	Up to 4 weeks after last treatment
Secondary	Objective response rate (ORR)	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.	Up to 2 years
Secondary	Disease control rate (DCR)	The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for =8 weeks) based on RECIST Version 1.1.	Up to 2 years
Secondary	Maximum observed concentration (Cmax) of 6MW3511	The endpoints for assessment of PK of 6MW3511 include serum concentrations of 6MW3511 at different timepoints after administration.	Up to 4 weeks after last treatment
Secondary	Number of subjects who develop detectable anti-drug antibodies (ADAs)	The immunogenicity of 6MW3511 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).	Up to 4 weeks after last treatment