Study of Liposomal Annamycin for the Treatment of Subjects with Soft-Tissue Sarcomas (STS) with Pulmonary Metastases

NCT04887298 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MB-107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.

Conditions

Sarcoma,Soft Tissue; Pulmonary Metastasis

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

  Number of patients with a dose limiting toxicity (DLT) at each dose evaluated

  21 days

Secondary Outcomes (2)

• Efficacy of L-Annamycin

  At the end of every other treatment cycle ( each cycle is 21 days)

• Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin

  Cycle 1 Day 1 ( each cycle is 21 days)

Study Arms (1)

Liposomal Annamycin (L-Annamycin)

EXPERIMENTAL

Drug: Liposomal Annamycin (L-Annamycin)

Interventions

Liposomal Annamycin (L-Annamycin) DRUG

2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days)

Liposomal Annamycin (L-Annamycin)

Eligibility Criteria

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

You may qualify if:

• The subject has a pathologically confirmed diagnosis of STS.
• The subject must have radiographically measurable disease in the lung that can be assessed using RECIST v.1.1 (defined as the presence of at least one lesion on MRI or CT scan that can be accurately measured with the longest diameter in at least one dimension of ≥10 mm). Subjects with extra-pulmonary disease are eligible.
• The subject has documented lung metastases that are considerable eligible for chemotherapy and not eligible for potentially curative surgical resection of pulmonary-only metastatic disease.
• The subject had prior therapy for their disease and has shown progression of disease prior to study entry. If the subject received prior anthracycline therapy, they must have received a cumulative dose of ≤ 450 mg/m2.
• The subject has an estimated life expectancy of greater than 3 months.
• The subject has an ECOG performance status ≤2.
• The subject is ≥18 years old at the time of signing informed consent.
• At least 2 weeks must have passed following treatment for subject's disease with chemotherapy, investigational therapy, targeted agents, biological agents, immune modulators, or radiotherapy.
• Any toxicities must have resolved to ≤ grade 1 or previous baseline levels no more than 4 weeks after completing therapy (except alopecia and polyneuropathy).
• The subject must have the following adequate laboratory results within 72 hours of starting protocol therapy:
• Absolute neutrophil count ≥ 1500/mL
• Platelet count ≥100,000/mL
• Hemoglobin ≥ 8.0 g/dL
• Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance.
• CrCl (male) = (\[140-age\] x weight in kg) / (serum creatinine x 72)

You may not qualify if:

• The subject has any uncontrolled intercurrent illness that, in the opinion of the Investigator, would place the subject at unacceptable risk to participate in the study. Examples include, but are not limited to:
• Ongoing or active infection
• Known positive status for human immunodeficiency virus (HIV) or active hepatitis B or C
• Cirrhosis
• Psychiatric illness/social situations that would limit compliance with study requirements
• The subject has any of the following cardiotoxicities:
• Left ventricular ejection fraction (LVEF) \<50%
• Valvular heart disease
• Severe hypertension not controlled by medical therapy
• New York Heart Association classification of 3 or 4 (Appendix B)
• Recent (≤ 6 months) myocardial infarction
• Unstable angina
• Symptomatic congestive heart failure
• Baseline QT/QTc interval \>480 msec
• History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Sponsors & Collaborators

• Moleculin Biotech, Inc.: lead

Study Sites (5)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Robert Shepard, MD

  Moleculin Biotech, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 14, 2021
• Study Start: June 5, 2021
• Primary Completion: September 29, 2022
• Study Completion: August 6, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)