Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05524194
Other study ID # 6MW3511-2022-CP101
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00750841 - Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours Phase 1
Withdrawn NCT05419817 - Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System Phase 2
Completed NCT02828930 - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) Phase 1
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Completed NCT03258515 - A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers Phase 1
Terminated NCT03225105 - M3541 in Combination With Radiotherapy in Solid Tumors Phase 1
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT03634982 - Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors Phase 1
Recruiting NCT04685226 - A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT06036121 - A Study of ADRX-0706 in Select Advanced Solid Tumors Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT01528046 - Metformin in Children With Relapsed or Refractory Solid Tumors Phase 1
Recruiting NCT05325866 - A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Phase 1/Phase 2
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Completed NCT02279433 - A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b Phase 1