A Phase I Study of MSB2311 in Advanced Solid Tumors

NCT03463473 | Completed Phase 1 FDA Drug

• 1 other identifier: MSB2311-CSP-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of MSB2311

  Measured by number adverse events that are related to treatment

  Up to 90 days following the last dose

• Maximum tolerated dose or recommended phase 2 dose

  Measured by number of subjects experiencing DLT in each escalation cohort

  Up to 90 days following the last dose

Secondary Outcomes (10)

• Area under the plasma concentration versus time curve (AUC) for MSB2311

  Up to 30 days following the last dose

• Peak Plasma concentration (Cmax)for MSB2311

  Up to 30 days following the last dose

• Volume of plasma from which MSB2311 is completely removed per unit time (CL)

  Up to 30 days following the last dose

• The incidence of subjects generating anti-drug antibody

  Up to 30 days following the last dose

• Objective response rate (ORR) as measured by RESISTv1.1

  Up to 30 days following the last dose

Study Arms (4)

3 mg/kg (Q3W) MSB2311 Injection

EXPERIMENTAL

MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 3 mg/kg.

Drug: 3 mg/kg Q3W MSB2311 Injection

10 mg/kg (Q3W) MSB2311 Injection

EXPERIMENTAL

MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 10 mg/kg.

Drug: 10 mg/kg Q3W MSB2311 Injection

20 mg/kg (Q3W) MSB2311 Injection

EXPERIMENTAL

MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 20 mg/kg.

Drug: 20 mg/kg Q3W MSB2311 Injection

10 mg/kg (Q2W) MSB2311 Injection

EXPERIMENTAL

MSB2311 will be administered as an IV infusion once every 2weeks (Q2W) starting at 10 mg/kg.

Drug: 10 mg/kg Q2W MSB2311 Injection

Interventions

3 mg/kg Q3W MSB2311 Injection DRUG

An intravenous infusion with concentration from 3 mg/kg (Q3W)

Also known as: 3 mg/kg Q3W MSB2311

3 mg/kg (Q3W) MSB2311 Injection

10 mg/kg Q3W MSB2311 Injection DRUG

An intravenous infusion with concentration from 10 mg/kg (Q3W)

Also known as: 10 mg/kg Q3W MSB2311

10 mg/kg (Q3W) MSB2311 Injection

20 mg/kg Q3W MSB2311 Injection DRUG

An intravenous infusion with concentration from 20 mg/kg (Q3W)

Also known as: 20 mg/kg Q3W MSB2311

20 mg/kg (Q3W) MSB2311 Injection

10 mg/kg Q2W MSB2311 Injection DRUG

An intravenous infusion with concentration from 10 mg/kg (Q2W)

Also known as: 10 mg/kg Q2W MSB2311

10 mg/kg (Q2W) MSB2311 Injection

Eligibility Criteria

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

You may qualify if:

• Able to understand and willing to sign the ICF.
• Male or female subject ≥ 18 years.
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for which no standard therapy exists.
• Subject has measurable disease per RECIST v1.1.
• ECOG Performance Status 0 to 1
• Subjects with life expectancy of ≥ 3 month
• No herbal/alternative medications prior to the first dose
• Must have adequate hematological, hepatic and renal function as defined in the protocol.
• Prior anti-tumor therapies of different kinds must have stopped before the first dose as defined by protocol
• Effective contraception for both male and female subjects if the risk of conception exists

You may not qualify if:

• Pregnant or nursing females.
• Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v4. 03, with exception of the residual hair loss;
• Received a biologic G-CSF, GM-CSF or erythropoietin within 14 days prior to the first dose of study drug;
• Subjects who had prior treatment with an anti-PD-L1 product
• History of documented autoimmune disease except for autoimmune hypothyroidism and well-controlled Type 1 diabetes mellitus.
• W/o autoimmune condition requiring systemic treatment with immunosuppressive medications within 14 days before the planned first dose of study drug.
• Primacy central nervous system (CNS) malignancy or symptomatic CNS metastases are not allowed, with exceptions defined in protocol.
• Major surgery within the 28-days from the screening
• Subjects with idiopathic pulmonary fibrosis or unresolved active or chronic inflammatory pulmonary disease are excluded.
• History of human immunodeficiency virus (HIV) infection, active hepatitis B or C. HBV carriers
• History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis disease.
• Clinically significant acute infections 4 weeks and any infection 2 weeks prior to the first dose administration.
• Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy
• Subjects who experienced immunotherapy-related adverse events (irAE) grade ≥ 3, or who had to discontinue prior anti-PD-1 treatment due to irAEs of any grade.
• Severe or uncontrolled cardiac disease requiring treatment as defined in protocol

Sponsors & Collaborators

• Suzhou Transcenta Therapeutics Co., Ltd.: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Study Officials

• Yonggang Wu, MD

  Suzhou Transcenta Therapeutics Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Model Details: Dose escalation : 3mg/kg Q3W, 10 mg/kg Q3W, 20 mg/kg Q3W, 10 mg/kg Q2W

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 13, 2018
• Study Start: April 12, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 18, 2023

Record last verified: 2019-05

Locations

US (1)