NCT05159518 is a Phase 1 clinical trial of PRT2527 in Sarcoma, sponsored by Prelude Therapeutics.

Who is sponsoring NCT05159518?

NCT05159518 is sponsored by Prelude Therapeutics.

What drugs are being tested in NCT05159518?

Interventions in NCT05159518: PRT2527.

What condition does NCT05159518 study?

NCT05159518 studies Sarcoma, Castrate Resistant Prostate Cancer, Hormone Receptor Positive HER2 Negative Breast Cancer, Non-small Cell Lung Cancer, Solid Tumors With Known MYC Amplification.

Is NCT05159518 still recruiting?

NCT05159518 is currently completed. Last updated 11 December 2023.

Last reviewed 2023-12-11 · How we verify

NCT05159518

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

A Study of PRT2527 in Participants With Advanced Solid Tumors

Completed Phase 1 Last updated 11 December 2023

What this trial tests

Phase 1 trial testing PRT2527 in Sarcoma in 30 participants. Completed in 6 December 2023.

Timeline

14 February 2022

Primary endpoint
6 December 2023

6 December 2023

Quick facts

Lead sponsor	Prelude Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	14 February 2022
Primary completion	6 December 2023
Estimated completion	6 December 2023
Sites	8 locations across United States

Drugs / interventions tested

PRT2527 — full drug profile →

Conditions studied

Sarcoma — all drugs for Sarcoma →
Castrate Resistant Prostate Cancer — all drugs for Castrate Resistant Prostate Cancer →
Hormone Receptor Positive HER2 Negative Breast Cancer — all drugs for Hormone Receptor Positive HER2 Negative Breast Cancer →
Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Prelude Therapeutics — full company profile →

Who can join

18 and older, any sex, with Sarcoma or Castrate Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.

Publications & conference data

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

The promising role of new molecular biomarkers in prostate cancer: from coding and non-coding genes to artificial intelligence approaches.
Alarcón-Zendejas AP, Scavuzzo A, Jiménez-Ríos MA, Álvarez-Gómez RM, et al · · 2022 · cited 60× · PMID 35422101 · DOI 10.1038/s41391-022-00537-2
Seize the engine: Emerging cell cycle targets in breast cancer.
Fuentes-Antrás J, Bedard PL, Cescon DW. · · 2024 · cited 21× · PMID 38264947 · DOI 10.1002/ctm2.1544
Effects of super-enhancers in cancer metastasis: mechanisms and therapeutic targets.
Liu S, Dai W, Jin B, Jiang F, et al · · 2024 · cited 20× · PMID 38844984 · DOI 10.1186/s12943-024-02033-8
Superenhancers as master gene regulators and novel therapeutic targets in brain tumors.
Zhuang HH, Qu Q, Teng XQ, Dai YH, et al · · 2023 · cited 20× · PMID 36720920 · DOI 10.1038/s12276-023-00934-0
The Present and Future of Clinical Management in Metastatic Breast Cancer.
Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891
The Role of CDK Pathway Dysregulation and Its Therapeutic Potential in Soft Tissue Sarcoma.
Thiel JT, Daigeler A, Kolbenschlag J, Rachunek K, et al · · 2022 · cited 14× · PMID 35884441 · DOI 10.3390/cancers14143380
Targeting neutrophils for cancer therapy.
Kwak JW, Houghton AM. · · 2025 · cited 11× · PMID 40374764 · DOI 10.1038/s41573-025-01210-8
Targeting the Heterogeneous Genomic Landscape in Triple-Negative Breast Cancer through Inhibitors of the Transcriptional Machinery.
van der Noord VE, van de Water B, Le Dévédec SE. · · 2022 · cited 11× · PMID 36139513 · DOI 10.3390/cancers14184353

Verify or expand the search:

Other trials of PRT2527

Trials testing the same drug.

NCT05665530 — A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologi · Phase 1 · completed

Other recruiting trials for Sarcoma

Currently open trials in the same condition.

NCT07402577 — Brief Title Mechanisms of Cancer-Related Pain and Opioid Use Among Adolescents and Young Adult Sarcoma Survivors: Pilot · recruiting
NCT07501026 — Preoperative Spatially Fractionated Radiation Therapy (SFRT) in Soft Tissue Sarcoma (neoSFRT-SARC) · Phase 2 · recruiting
NCT07359911 — Effect of A Multimodal Exercise Intervention on Chemotherapy Uptake in Newly Diagnosed Pediatric and AYA Sarcoma Patient · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting

Other Prelude Therapeutics trials

Trials by the same sponsor.

NCT06682806 — A Study of PRT3789 in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 · Phase 2 · terminated
NCT06560645 — A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutati · Phase 1 · terminated
NCT05665530 — A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologi · Phase 1 · completed
NCT05639751 — PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation · Phase 1 · completed
NCT05538572 — A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors · Phase 1 · completed

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 NCT05159518 (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 Prelude Therapeutics
Last refreshed: 11 December 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/NCT05159518.

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