NCT03565003

A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China

Completed Phase 1, PHASE2 Last updated 25 September 2024

What this trial tests

Phase 1, PHASE2 trial testing JAB-3068 in Non-small Cell Lung Cancer in 126 participants. Completed in 31 January 2023.

Timeline

20 November 2018

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Jacobio Pharmaceuticals Co., Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	20 November 2018
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	4 locations across China

Drugs / interventions tested

• JAB-3068 — full drug profile →

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Esophageal Cancer — all drugs for Esophageal Cancer →
• Other Metastatic Solid Tumors — all drugs for Other Metastatic Solid Tumors →

Sponsor

Jacobio Pharmaceuticals Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.

Publications & conference data

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

1. RAS-targeted therapies: is the undruggable drugged?
   Moore AR, Rosenberg SC, McCormick F, Malek S. · · 2020 · cited 832× · PMID 32528145 · DOI 10.1038/s41573-020-0068-6
2. The current state of the art and future trends in RAS-targeted cancer therapies.
   Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
3. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
   Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
4. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.
   Majeed U, Manochakian R, Zhao Y, Lou Y. · · 2021 · cited 193× · PMID 34238332 · DOI 10.1186/s13045-021-01121-2
5. Emerging strategies to target RAS signaling in human cancer therapy.
   Chen K, Zhang Y, Qian L, Wang P. · · 2021 · cited 164× · PMID 34301278 · DOI 10.1186/s13045-021-01127-w
6. Insulin receptor endocytosis in the pathophysiology of insulin resistance.
   Hall C, Yu H, Choi E. · · 2020 · cited 94× · PMID 32576931 · DOI 10.1038/s12276-020-0456-3
7. Tyrosine phosphatase SHP2 inhibitors in tumor-targeted therapies.
   Song Z, Wang M, Ge Y, Chen XP, et al · · 2021 · cited 91× · PMID 33532178 · DOI 10.1016/j.apsb.2020.07.010
8. Mechanisms of Resistance to KRAS<sup>G12C</sup> Inhibitors.
   Dunnett-Kane V, Nicola P, Blackhall F, Lindsay C. · · 2021 · cited 90× · PMID 33466360 · DOI 10.3390/cancers13010151