Phase I, Open-label, Non-randomized Study to Evaluate Safety of BC2059

NCT03459469 | Completed Phase 1 FDA Drug

• 1 other identifier: BCI-001-DT17
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 7

Brief Summary

Phase I, open-label, non-randomized study to evaluate safety of BC2059 administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.

Conditions

Desmoid Tumor

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability

  Adverse events, Serious adverse events and Dose limiting toxicities

  12 Months

Secondary Outcomes (1)

• 1. To determine the durability of response (DOR) to BC2059 after the achievement of best response

  12 Months

Study Arms (1)

Investigational drug

EXPERIMENTAL

An open-label, non-randomized study to evaluate safety of Tegavivint administered intravenously to subjects with proven primary or recurrent desmoid tumor that is unresectable and symptomatic or progressive.

Drug: Tegavivint

Interventions

Tegavivint DRUG

This is an Investigational drug

Also known as: BC2059

Investigational drug

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven primary or recurrent desmoid tumor with currently bi-dimensionally measurable tumor by WHO criteria.
• Patients with disease that is either unresectable or for which the patient refuses surgery but is currently progressing, as defined by:
• % increase in tumor volume within 6 months OR
• Recurrent disease within 1 year of surgery OR
• Desmoid related symptoms as documented by a PRO questionnaire and documentation that symptoms are related to desmoid and not prior therapies.
• Willingness to provide tumor biopsies prior to treatment and while on treatment
• Patients may have been previously treated with local therapies such as surgery, radiation, radiofrequency ablation, or cryosurgery provided this has been completed at least 4 weeks prior to registration and recovered from therapy related toxicity to less than CTCAE grade 2 and show no improvement in tumor size or symptom score.
• Patients may have been treated with systemic therapies such as tyrosine kinase inhibitors, hormone inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) provided this has been completed at least 4 weeks prior to registration and recovered from any therapy related toxicity to less than CTCAE grade 2 and show no improvement in tumor size or symptom score.
• Patients may have been treated with systemic therapies such as cytotoxics, biologics or other unclassified experimental therapies provided this has been completed at least 8 weeks prior to registration and recovered from any therapy related toxicity to less than CTCAE grade 2 and show no improvement in tumor size or symptom score.
• Patients who have been treated with immune therapies such as vaccines, dendritic or other whole cell therapies, oncolytic or other viral approaches within the preceding 12 months should be discussed with the Medical Monitor prior to screening and enrollment into the study to determine eligibility.
• Age: 18 and over (no pre-pubertal patients)
• ECOG Performance status: 0-1
• Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one highly effective method of contraception, including hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstain from sex for the duration of study participation and for 4 months following completion of BC2059 administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. See section 8.7.3 for more information.
• Contraception includes:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception

You may not qualify if:

• Patients who have not recovered to grade 1 from adverse events related to prior therapy excluding those considered not clinically significant (ex. Lymphopenia).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BC2059 or other agents used in study
• Patients with metabolic bone disease (ex. Hyperparathyroidism, Paget's disease, or osteomalacia)
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality or QTc \> 480 msec
• Uncontrolled concurrent illness including, but not limited to: ongoing or active infection (Viral, bacterial, fungal or other)
• Psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant and breastfeeding women are excluded from this study. The effects of BC2059 on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BC2059.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with BC2059
• Patients with abnormal serum chemistry values other than the specific limits detailed above, that in the opinion of the Investigator is considered to be clinically significant, should be discussed with the Medical Monitor before being enrolled in the study.
• Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
• Personal history of malignancy except:
• Cervical intraepithelial neoplasia;
• Skin basal cell carcinoma;
• Treated localized prostate carcinoma with PSA \<1 ng/mL;
• Neoplasia treated with curative intent, in remission for at least five years and considered at low risk of relapse.

Sponsors & Collaborators

• Iterion Therapeutics: lead

Study Sites (7)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202, United States

Location

MD Anderson Cancer Center

Houston, Texas, 770030, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Desmoid Tumors

Condition Hierarchy (Ancestors)

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

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: March 1, 2018
• First Posted: March 9, 2018
• Study Start: July 15, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); CA (1)