6MW3511 in Patients With Advanced Solid Tumor

NCT05524194 | Unknown Phase 1

• 1 other identifier: 6MW3511-2022-CP101
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Maximum observed concentration (Cmax) of 6MW3511

  Up to 4 weeks after last treatment

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  Up to 4 weeks after last treatment

Study Arms (1)

Experimental: 6MW3511

EXPERIMENTAL

Subjects will receive 6MW3511 by intravenous administration.

Drug: Intravenous Infusion

Interventions

Intravenous Infusion DRUG

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).

Experimental: 6MW3511

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive).
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

You may not qualify if:

• History of other malignant tumors within 3 years, except for the tumors that had been cured.
• Symptomatic or active central nervous system metastasis.
• Patients with active autoimmune disease.
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
• Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody.
• Pregnant or breast feeding.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

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: August 28, 2022
• First Posted: September 1, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 1, 2022

Record last verified: 2022-08