A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors

NCT04592484 | Completed Phase 1 FDA Drug

• 1 other identifier: CDK-002-101
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a first-in-human, Phase 1/2 open-label, multicenter, dose escalation, safety, pharmacodynamic, and PK study of CDK-002 in subjects with advanced/metastatic, recurrent, injectable solid tumors, whose disease has progressed despite receiving standard of care treatment. CDK 002 will be administered intratumorally (IT). Part A will enroll subjects with advanced/metastatic, recurrent, injectable solid tumors with emphasis on head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), anaplastic thyroid carcinoma (ATC) and cutaneous squamous cell carcinoma (cSCC).

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• To determine the safety and tolerability of ascending doses of CDK-002

  Incidence of treatment-emergent adverse events as assessed by CTCAE

  up to 2 years

Study Arms (1)

CDK-002

EXPERIMENTAL

Biological: CDK-002

Interventions

CDK-002 BIOLOGICAL

CDK-002 administered intratumorally

CDK-002

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years at the time of signing the informed consent form.
• Histologically confirmed advanced, recurrent or metastatic injectable solid tumor and has received the following prior therapy:
• HNSCC: Subject must have been previously treated with a platinum-based chemotherapy regimen and/or a programmed cell death-protein 1 (PD-1) inhibitor.
• TNBC: Subject must have been treated with at least 1 chemotherapy regimen and/or PD-L1 or PD-1 inhibitor for metastatic disease.
• ATC: Subject must be considered inoperable and not considered to benefit from additional chemotherapy and/or radiation.
• cSCC: Subject must have previously been treated with radiation therapy and/or chemotherapy and/or PD-L1 or PD-1 inhibitor.
• Subjects with other advanced solid tumors that have progressed following standard therapy or for which there is no standard of care therapy with an overall survival (OS) benefit.
• Measurable disease per RECIST v1.1 and ≥1 lesion that is measurable (ie, ≥1.0 cm by CT, MRI, or ruler or caliper measurements for cutaneous lesions or other superficial lesions in longest diameter \[non-lymph nodes\] or ≥1.5 cm in shortest diameter for lymph nodes) and amenable to tumoral injection and biopsy per Investigator assessment.
• Agrees to have a pre-treatment tumor biopsy within 7 days prior to the first dose of CDK-002, and 2 on-treatment tumor biopsies of the same lesion. Biopsies may be core needle, incisional, or excisional biopsies. For cutaneous lesions, a punch biopsy may be acceptable. Fine needle aspiration (FNA) is not acceptable.
• Understands and can comply with the study requirements and has signed the informed consent form.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy of at least 3 months.
• Acceptable liver function.
• Acceptable renal function.
• Acceptable hematologic status.

You may not qualify if:

• Prior treatment with a STING agonist.
• Cytotoxic chemotherapy, biologic agents, investigational agents, or radiation therapy within 4 weeks prior to the first dose of CDK 002 (6 weeks for nitrosoureas or mitomycin C). The interval can be reduced to 2 weeks for bone-only radiation therapy.
• Small-molecule kinase inhibitors or hormonal anticancer agents within 14 days prior to the first dose of CDK 002.
• Clinically significant ongoing AEs that have not returned to baseline or to Grade 1 NCI CTCAE v5.0.
• Immunosuppressive agents including corticosteroids within 14 days of first dose of CDK 002. Topical, intranasal or inhaled corticosteroids, physiologic doses of systemic steroids or limited treatment with systemic steroids (ie, for IV contrast prophylaxis) may be administered with Sponsor approval.
• Major surgery within 6 weeks or minor surgery (excluding tumor biopsies) within 14 days prior to the first dose of CDK 002 or if subject has not clinically recovered.
• Clinically active central nervous system (CNS) metastases or carcinomatous meningitis. Subjects with stable brain metastasis may be enrolled with Sponsor approval.
• Metastatic liver involvement that exceeds one-third of total liver volume.
• Clinically significant cardiovascular disease including but not limited to New York Heart Association Class III or IV heart failure, myocardial infarction or stroke within the past 6 months prior to the first dose of CDK 002, uncontrolled arrhythmia, or severe aortic stenosis. Sponsor approval of subjects with an arrhythmia is required.
• History of myocarditis.
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. Prophylactic antibiotics are acceptable.
• Prior organ or stem cell transplant.
• Primary immune deficiency.
• Pregnant or nursing women.
• Active Hepatitis B or C infection.

Sponsors & Collaborators

• Codiak BioSciences: lead

Study Sites (8)

Honor Health

Scottsdale, Arizona, 85258, United States

Location

Columbia University/CUMC

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

The Beatson West of Scotland Cancer Centre/ Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Oxford University Hospitals NHS Trust

Headington, OX3 9DU, United Kingdom

Location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Study Officials

• Roger Cohen, MD

  University of Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

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: August 18, 2020
• First Posted: October 19, 2020
• Study Start: September 15, 2020
• Primary Completion: August 3, 2022
• Study Completion: December 23, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); US (4)