NCT03810339 is a Phase 2 clinical trial of Toripalimab in Solid Tumor, sponsored by Sun Yat-sen University.

Who is sponsoring NCT03810339?

NCT03810339 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT03810339?

Interventions in NCT03810339: Toripalimab.

What condition does NCT03810339 study?

NCT03810339 studies Solid Tumor, Advanced Cancer.

Is NCT03810339 still recruiting?

NCT03810339 is currently status unknown. Last updated 27 June 2023.

Last reviewed 2023-06-27 · How we verify

NCT03810339

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

Toripalimab as Monotherapy in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid Tumors

Status unknown Phase 2 Last updated 27 June 2023

What this trial tests

Phase 2 trial testing Toripalimab in Solid Tumor in 35 participants. Status unknown.

Timeline

15 January 2019

Primary endpoint
15 January 2024

15 January 2024

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	15 January 2019
Primary completion	15 January 2024
Estimated completion	15 January 2024
Sites	1 location across China

Drugs / interventions tested

Toripalimab (TORIPALIMAB) — full drug profile →

Conditions studied

Solid Tumor — all drugs for Solid Tumor →
Advanced Cancer — all drugs for Advanced Cancer →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Solid Tumor or Advanced Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the response of toripalimab (JS001), a PD1 antibody, in participants with POLE or POLD-mutated and non microsatellite instability (non-MSI-H) advanced solid cancers.

Publications & conference data

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

Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y
POLE/POLD1 mutation and tumor immunotherapy.
Ma X, Dong L, Liu X, Ou K, et al · · 2022 · cited 90× · PMID 35780178 · DOI 10.1186/s13046-022-02422-1
Programmed cell death-ligand 2: A neglected but important target in the immune response to cancer?
Solinas C, Aiello M, Rozali E, Lambertini M, et al · · 2020 · cited 61× · PMID 32622310 · DOI 10.1016/j.tranon.2020.100811
The role of DNA damage repair (DDR) system in response to immune checkpoint inhibitor (ICI) therapy.
Shi C, Qin K, Lin A, Jiang A, et al · · 2022 · cited 60× · PMID 36071479 · DOI 10.1186/s13046-022-02469-0
Wedding of Molecular Alterations and Immune Checkpoint Blockade: Genomics as a Matchmaker.
Fountzilas E, Kurzrock R, Vo HH, Tsimberidou AM. · · 2021 · cited 39× · PMID 33823006 · DOI 10.1093/jnci/djab067
Biomarkers of Response and Resistance to Immunotherapy in Microsatellite Stable Colorectal Cancer: Toward a New Personalized Medicine.
Huyghe N, Benidovskaya E, Stevens P, Van den Eynde M. · · 2022 · cited 36× · PMID 35565369 · DOI 10.3390/cancers14092241
Predictive molecular markers for the treatment with immune checkpoint inhibitors in colorectal cancer.
Du F, Liu Y. · · 2022 · cited 21× · PMID 34817097 · DOI 10.1002/jcla.24141
Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gastrointestinal cancer.
Kelly RJ, Bever K, Chao J, Ciombor KK, et al · · 2023 · cited 20× · PMID 37286304 · DOI 10.1136/jitc-2022-006658

Verify or expand the search:

Other trials of Toripalimab

Trials testing the same drug.

NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07423078 — Window of Opportunity in Preserving Laryngeal Function Trial · Phase 2 · recruiting
NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
NCT07469956 — Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancre · Phase 2 · not yet recruiting

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

NCT07489378 — NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rar · recruiting
NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting

Other Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · 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 NCT03810339 (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 Sun Yat-sen University
Last refreshed: 27 June 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/NCT03810339.

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