Study to Evaluate Safety, PK, PD, Immunogenicity & Antitumor Activity of MSC-1 in Patients With Adv Solid Tumors

NCT03490669 | Completed Phase 1 FDA Drug

• 2 other identifiers: MSC-1-1012017-003320-79
• Study Type: interventional
• Target: 41
• Locations: 3 countries
• Sites: 7

Brief Summary

This is a 2-part study to evaluate the safety and antitumor activity of MSC-1. MSC-1 is a first-in-class, humanized monoclonal antibody (IgG1) which binds to the immunosuppressive human cytokine Leukemia Inhibitory Factor (LIF), and is intended to treat adult patients with Advanced Solid Tumors. In part 1, multiple dose levels of MSC-1 in patients with advanced solid tumors will be studied to determine the recommended dose for further evaluation of safety and efficacy in Part 2.

Conditions

Advanced Solid Tumors; Pancreatic Cancer; Non Small Cell Lung Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of MSC-1 and determine the recommended dose for MSC-1 monotherapy for further evaluation in the expansion part of the study

  Assessment of frequency \& severity of adverse events

  Patients will be evaluated for approximately 6 months or until disease progression

• Assess the preliminary anti-tumor activity of MSC-1 monotherapy

  Determine objective response rate (ORR)

  Patients will be evaluated for approximately 6 months or until disease progression

Secondary Outcomes (2)

• Confirm safest dose of MSC-1 for further study

  Patients will be evaluated for approximately 6 months or until disease progression

• Characterize the PK of MSC-1

  Patients will be evaluated before and after each dose of MSC-1 for approximately 6 months or until disease progression. PK will be evaluated more frequently for the first 2 cycles of treatment

Study Arms (2)

Dose Escalation

EXPERIMENTAL

Multiple dose levels of MSC-1 treatment once every 3 weeks

Biological: MSC-1

Dose Expansion

EXPERIMENTAL

MSC-1 treatment at the recommended Phase 2 dose once every 3 weeks

Biological: MSC-1

Interventions

MSC-1 BIOLOGICAL

humanized monoclonal antibody for intravenous administration

Dose Escalation; Dose Expansion

Eligibility Criteria

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

You may qualify if:

• Confirmed Advanced Unresectable Solid Tumor
• Measurable disease by RECIST 1.1 by CT or MRI
• Documented disease progression on or following last line of therapy
• Archival tumor sample for submission
• ECOG performance status 0 or 1
• Resolution of all acute, reversible toxic effects of prior therapy or surgical procedures to at least grade 1 (except alopecia and peripheral neuropathy to at least grade 2)
• Adequate organ function
• A limited number of patients enrolled in Dose Escalation may be required to agree to pre- and on-treatment tumor biopsies
• LIF- High NSCLC, Ovarian Cancer, or Pancreatic Cancer for the tumor-specific cohorts or Advanced Solid Tumor for the basket cohort as assessed by tumor tissue evaluation by IHC
• All patients enrolled in Dose Expansion must agree to undergo pre- and on-treatment tumor biopsies

You may not qualify if:

• Systemic anti-cancer therapy within 4 weeks or 5 half-lives prior to study entry
• Previous or concurrent malignancy that could affect compliance with protocol or interpretation of results
• Clinically significant, unstable cardiovascular or pulmonary disease as specified in detail in the study protocol
• History of acquired or congenital immunodeficiency syndrome or receiving immunosuppressive therapy
• Uncontrolled infections or serologically positive HIV or hepatitis B or C infection
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or interfere with interpretation of study results

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

START MidWest

Grand Rapids, Michigan, 49546, United States

Location

Memorial Sloan Kettering Cancer Center- Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center- Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Links

• Sponsor Website
• CSR Synopsis

MeSH Terms

Conditions

Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders

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: Open-Label

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: April 6, 2018
• Study Start: May 21, 2018
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

CA (1); ES (1); US (5)