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NCT04901806
Study of PBI-200 in Subjects With NTRK-Fusion-Positive Solid Tumors
Terminated
Phase 1
Last updated 28 March 2024
What this trial tests
Phase 1 trial testing PBI-200 in Solid Tumor, Adult in 29 participants. Terminated before completion.
Timeline
20 July 2021
Primary endpoint
26 July 2023
26 July 2023
26 July 2023
Quick facts
| Lead sponsor | Pyramid Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 29 |
| Start date | 20 July 2021 |
| Primary completion | 26 July 2023 |
| Estimated completion | 26 July 2023 |
| Sites | 42 locations across Denmark, France, Hong Kong, Italy, United Kingdom, Germany, South Korea, Australia |
Drugs / interventions tested
- PBI-200
Conditions studied
- Solid Tumor, Adult — all drugs for Solid Tumor, Adult →
- Brain Tumor, Primary — all drugs for Brain Tumor, Primary →
- Desmoplastic Small Round Cell Tumor — all drugs for Desmoplastic Small Round Cell Tumor →
Sponsor
Pyramid Biosciences — full company profile →
Who can join
18 and older, any sex, with Solid Tumor, Adult or Brain Tumor, Primary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a first-in-human, open-label, multicenter, dose-escalation, safety, PK, and biomarker study of PBI-200 in subjects with NTRK-fusion-positive advanced or metastatic solid tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
NTRK Fusion in Non-Small Cell Lung Cancer: Diagnosis, Therapy, and TRK Inhibitor Resistance.
Liu F, Wei Y, Zhang H, Jiang J, et al · · 2022 · cited 61× · PMID 35372074 · DOI 10.3389/fonc.2022.864666 -
TRK inhibitor activity and resistance in TRK fusion-positive cancers in adults.
Harada G, Drilon A. · · 2022 · cited 36× · PMID 35334340 · DOI 10.1016/j.cancergen.2022.03.002 -
Molecular pathways, resistance mechanisms and targeted interventions in non-small-cell lung cancer.
Wang Z, Xing Y, Li B, Li X, et al · · 2022 · cited 31× · PMID 36508072 · DOI 10.1186/s43556-022-00107-x -
Selective type II TRK inhibitors overcome xDFG mutation mediated acquired resistance to the second-generation inhibitors selitrectinib and repotrectinib.
Xiang S, Lu X. · · 2024 · cited 25× · PMID 38322338 · DOI 10.1016/j.apsb.2023.11.010 -
Desmoplastic small round cell tumor: from genomics to targets, potential paths to future therapeutics.
Magrath JW, Espinosa-Cotton M, Flinchum DA, Sampath SS, et al · · 2024 · cited 14× · PMID 39139449 · DOI 10.3389/fcell.2024.1442488 -
Immunotherapy and Radioimmunotherapy for Desmoplastic Small Round Cell Tumor.
Espinosa-Cotton M, Cheung NV. · · 2021 · cited 9× · PMID 34869013 · DOI 10.3389/fonc.2021.772862 -
Tissue-Agnostic Targeting of Neurotrophic Tyrosine Receptor Kinase Fusions: Current Approvals and Future Directions.
Gouda MA, Thein KZ, Hong DS. · · 2024 · cited 5× · PMID 39410015 · DOI 10.3390/cancers16193395 -
Desmoplastic Small Round Blue Cell Tumor in a Young Adult Man: A Rare Case of Abdominal Sarcoma.
Dirican CD, Ajayi F, Patel S, Bijoy S, et al · · 2026 · PMID 41770685 · DOI 10.12659/ajcr.950718
Verify or expand the search:
- PubMed search for NCT04901806
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PBI-200
Trials testing the same drug.
- NCT05160389 — A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 · Phase 1 · completed
Other recruiting trials for Solid Tumor, Adult
Currently open trials in the same condition.
- NCT07139990 — Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) · Phase 1 · recruiting
- NCT06398418 — R-5780-01 In Combination With PD-1 Checkpoint Inhibitors (Checkpoint Protein on Immune Cells Called T Cells) in Patients · Phase 1 · recruiting
- NCT06682793 — A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumor · Phase 1, PHASE2 · recruiting
- NCT07137195 — Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei) · NA · active not recruiting
- NCT06714617 — Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors · Phase 1 · active not recruiting
Other Pyramid Biosciences trials
Trials by the same sponsor.
- NCT05692570 — A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers · Phase 1 · completed
- NCT05690932 — A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers · Phase 1 · completed
- NCT05238337 — A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 · Phase 1 · completed
- NCT05514353 — A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream · Phase 1 · completed
- NCT05160389 — A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200 · 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 NCT04901806 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Pyramid Biosciences
- Last refreshed: 28 March 2024
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/NCT04901806.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing