NCT04592484 is a Phase 1, PHASE2 clinical trial of CDK-002 in Advanced Solid Tumor, sponsored by Codiak BioSciences.

Who is sponsoring NCT04592484?

NCT04592484 is sponsored by Codiak BioSciences.

What drugs are being tested in NCT04592484?

Interventions in NCT04592484: CDK-002.

What condition does NCT04592484 study?

NCT04592484 studies Advanced Solid Tumor.

Is NCT04592484 still recruiting?

NCT04592484 is currently completed. Last updated 8 February 2023.

Last reviewed 2023-02-08 · How we verify

NCT04592484

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Last updated 8 February 2023

What this trial tests

Phase 1, PHASE2 trial testing CDK-002 in Advanced Solid Tumor in 27 participants. Completed in 23 December 2022.

Timeline

15 September 2020

Primary endpoint
3 August 2022

23 December 2022

Quick facts

Lead sponsor	Codiak BioSciences
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	15 September 2020
Primary completion	3 August 2022
Estimated completion	23 December 2022
Sites	8 locations across United Kingdom, United States

Drugs / interventions tested

CDK-002 — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Codiak BioSciences — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The role of extracellular vesicles in cancer.
Kalluri R, McAndrews KM. · · 2023 · cited 452× · PMID 37059067 · DOI 10.1016/j.cell.2023.03.010
Chemical and Biomolecular Strategies for STING Pathway Activation in Cancer Immunotherapy.
Garland KM, Sheehy TL, Wilson JT. · · 2022 · cited 250× · PMID 35107989 · DOI 10.1021/acs.chemrev.1c00750
Type I interferon-mediated tumor immunity and its role in immunotherapy.
Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
Recent progress in targeted delivery vectors based on biomimetic nanoparticles.
Chen L, Hong W, Ren W, Xu T, et al · · 2021 · cited 209× · PMID 34099630 · DOI 10.1038/s41392-021-00631-2
Exosome-mediated genetic reprogramming of tumor-associated macrophages by exoASO-STAT6 leads to potent monotherapy antitumor activity.
Kamerkar S, Leng C, Burenkova O, Jang SC, et al · · 2022 · cited 202× · PMID 35179953 · DOI 10.1126/sciadv.abj7002
Current approaches of nanomedicines in the market and various stage of clinical translation.
Shan X, Gong X, Li J, Wen J, et al · · 2022 · cited 187× · PMID 35865096 · DOI 10.1016/j.apsb.2022.02.025
Harnessing innate immune pathways for therapeutic advancement in cancer.
Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
Development of Extracellular Vesicle Therapeutics: Challenges, Considerations, and Opportunities.
Claridge B, Lozano J, Poh QH, Greening DW. · · 2021 · cited 132× · PMID 34616741 · DOI 10.3389/fcell.2021.734720

Verify or expand the search:

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting

Other Codiak BioSciences trials

Trials by the same sponsor.

NCT05375604 — A Study of exoASO-STAT6 (CDK-004) in Patients With Advanced Hepatocellular Carcinoma (HCC) and Patients With Liver Metas · Phase 1 · terminated
NCT05156229 — A Phase 1/2a Study of CDK-003 in Patients With Cutaneous T-Cell Lymphoma (CTCL). · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04592484 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Codiak BioSciences
Last refreshed: 8 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04592484.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing