Who is sponsoring NCT05115500?

NCT05115500 is sponsored by Second Affiliated Hospital of Soochow University.

What drugs are being tested in NCT05115500?

Interventions in NCT05115500: ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2.

What condition does NCT05115500 study?

NCT05115500 studies Carcinoma, Solid Tumor.

Is NCT05115500 still recruiting?

NCT05115500 is currently status unknown. Last updated 10 November 2021.

Last reviewed 2021-11-10 · How we verify

NCT05115500

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

ADC Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of HER-2 Positive Advanced Solid Tumors(PRaG3.0)

Status unknown Phase 2 Last updated 10 November 2021

What this trial tests

Phase 2 trial testing ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 in Carcinoma in 55 participants. Status unknown.

Timeline

1 November 2021

Primary endpoint
31 October 2024

30 April 2025

Quick facts

Lead sponsor	Second Affiliated Hospital of Soochow University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	1 November 2021
Primary completion	31 October 2024
Estimated completion	30 April 2025
Sites	19 locations across China

Drugs / interventions tested

ADC Combined With Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 — full drug profile →

Conditions studied

Carcinoma — all drugs for Carcinoma →
Solid Tumor — all drugs for Solid Tumor →

Sponsor

Second Affiliated Hospital of Soochow University

Who can join

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

Sponsor's own description

This is an open-label, single-arm, Phase II investigator-initiated trial of antibody-drug conjugate combined with hypofractionated radiotherapy, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 for treatment of advanced refractory solid tumors with HER-2 positive

Publications & conference data

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

The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.
Wei Q, Li P, Yang T, Zhu J, et al · · 2024 · cited 102× · PMID 38178200 · DOI 10.1186/s13045-023-01509-2
Clinical perspective: Antibody-drug conjugates for the treatment of HER2-positive breast cancer.
Najminejad Z, Dehghani F, Mirzaei Y, Mer AH, et al · · 2023 · cited 45× · PMID 36950736 · DOI 10.1016/j.ymthe.2023.03.019
Drug conjugates for the treatment of lung cancer: from drug discovery to clinical practice.
Zhou L, Lu Y, Liu W, Wang S, et al · · 2024 · cited 27× · PMID 38429828 · DOI 10.1186/s40164-024-00493-8
Advances in Trop-2 targeted antibody-drug conjugates for breast cancer: mechanisms, clinical applications, and future directions.
Tong Y, Fan X, Liu H, Liang T. · · 2024 · cited 20× · PMID 39555080 · DOI 10.3389/fimmu.2024.1495675
Advancements in antibody-drug conjugates as cancer therapeutics.
Fong JY, Phuna Z, Chong DY, Heryanto CM, et al · · 2025 · cited 11× · PMID 40814440 · DOI 10.1016/j.jncc.2025.01.007
Combination treatment with anti-HER2 therapeutic antibody RC48, PD-1 inhibitor, radiotherapy, and granulocyte macrophage-colony stimulating factor (GM-CSF) in patient with metastatic gastric cancer: a case report.
Liu Z, Wang F, Zhang Y, Lu J, et al · · 2024 · cited 8× · PMID 38361930 · DOI 10.3389/fimmu.2024.1321946
Conjugated Nanoparticles for Solid Tumor Theranostics: Unraveling the Interplay of Known and Unknown Factors.
Chavda VP, Balar PC, Nalla LV, Bezbaruah R, et al · · 2023 · cited 8× · PMID 37867666 · DOI 10.1021/acsomega.3c05069
PRaG Therapy of Refractory Metastatic Gastric Cancer: A Case Report.
Xu H, Hong Z, Xu M, Kong Y, et al · · 2022 · cited 7× · PMID 35874658 · DOI 10.3389/fimmu.2022.926740

Verify or expand the search:

Other recruiting trials for Carcinoma

Currently open trials in the same condition.

NCT07257094 — Nasal Reconstruction FACE-Q : French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Reha · recruiting
NCT06969534 — Safety and Efficacy of Pucotenlimab in pLECC · Phase 2 · recruiting
NCT06676527 — Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma · recruiting
NCT07470827 — Evaluation of 'WAYMED Endo CL CS' for Automated Detection and Diagnosis of Colorectal Adenoma and Non-Adenoma Lesions · active not recruiting
NCT06317311 — A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Japanese Participants With Primary Advanced or Recu · Phase 2 · active not recruiting

Other Second Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

NCT07327411 — Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors · Phase 2 · not yet recruiting
NCT07241897 — DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes · Phase 3 · not yet recruiting
NCT07267234 — PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0) · Phase 2 · not yet recruiting
NCT07095790 — Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke · Phase 4 · recruiting
NCT07002502 — Immune Modulation With PRaG-1 Treatment · Phase 2 · not yet recruiting

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 NCT05115500 (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 Second Affiliated Hospital of Soochow University
Last refreshed: 10 November 2021

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/NCT05115500.

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