NCT03704246

Recombinant Human Anti-PD-1 Monoclonal Antibody HX008 Injection for the Treatment of Advanced Solid Tumors

Status unknown Phase 2 Last updated 4 March 2021

What this trial tests

Phase 2 trial testing Anti-PD-1 monoclonal antibody in Advanced Solid Tumor in 123 participants. Status unknown.

Timeline

30 September 2018

Primary endpoint
30 December 2019

30 March 2021

Quick facts

Lead sponsor	Taizhou Hanzhong biomedical co. LTD
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	30 September 2018
Primary completion	30 December 2019
Estimated completion	30 March 2021
Sites	30 locations across China

Drugs / interventions tested

• Anti-PD-1 monoclonal antibody — full drug profile →

Conditions studied

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

Sponsor

Taizhou Hanzhong biomedical co. LTD — 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

In this study, patients of advanced gastric adenocarcinoma with failed first-line chemotherapy-line or advanced mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) advanced solid carcinoma will be treated with HX008 combined with irinotecan and HX008 monotherapy There will be two cohorts in this study: Cohort 1 and Cohort 2. For Cohort 1, advanced gastric adenocarcinoma with failed first-line chemotherapy-line cancer participants, who had failed or were unable to tolerate first line chemotherapy with platinum-based or fluorouracil regimens. For Cohort 2, advanced solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Publications & conference data

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

1. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
2. Antibodies to watch in 2023.
   Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
3. Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
   Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295
4. HX008: a humanized PD-1 blocking antibody with potent antitumor activity and superior pharmacologic properties.
   Zhang J, Huang Y, Xi G, Zhang F. · · 2020 · cited 26× · PMID 32106752 · DOI 10.1080/19420862.2020.1724751
5. HX008, an anti-PD1 antibody, plus irinotecan as second-line treatment for advanced gastric or gastroesophageal junction cancer: a multicenter, single-arm phase II trial.
   Song Y, Li N, Li Q, Liang X, et al · · 2020 · cited 17× · PMID 33060149 · DOI 10.1136/jitc-2020-001279
6. Leading Edge: Intratumor Delivery of Monoclonal Antibodies for the Treatment of Solid Tumors.
   Blanco E, Chocarro L, Fernández-Rubio L, Bocanegra A, et al · · 2023 · cited 12× · PMID 36768997 · DOI 10.3390/ijms24032676
7. Phase I study of pucotenlimab (HX008), an anti-PD-1 antibody, for patients with advanced solid tumors.
   Liu R, Li W, Meng Y, Gao S, et al · · 2021 · cited 8× · PMID 34158838 · DOI 10.1177/17588359211020528
8. Immune checkpoint inhibitors-associated cardiotoxicity in immunotherapy trials on gastrointestinal cancer patients.
   Li Y, Wang Y, Li N, Liang X, et al · · 2022 · cited 5× · PMID 35730374 · DOI 10.1097/cm9.0000000000002054