A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title: A Phase Ia/Ib, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GH2616 Tablet in Subjects With Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).

Clinical Trial Description

Phase Ia: Dose Escalation Study This is a Phase Ia, open-label, multi-center, dose escalation study, aiming to investigate the safety, tolerability, PK, PD and preliminary anti-tumor activity of GH2616 Tablet in subjects with advanced solid tumors.

• Dose Escalation Phase This study will consist of 8, sequential, ascending-dose cohorts (A1~ A8) and utilize a "3+3" dose escalation design. The planned dose levels for each cohort (A1 ~ A8) are 50 mg, 100 mg, 200 mg, 400mg, 600 mg, 900 mg, 1200 mg and 1400 mg (tentative), respectively.

GH2616 Tablet will be orally administered once daily for 21 consecutive days of each cycle.

Phase Ib: Dose Expansion Study The Phase Ib part is an open-label, multi-center, dose expansion study, aiming to further evaluate the safety, tolerability, PK, PD, and preliminary anti-tumor activity of GH2616 Tablet in subjects with advanced solid tumors harboring TP53 mutation and WGD+ at the RDEs.

Phase Ib study will consist of 2 to 3 dose level cohorts (B1 ~ B3) of RDEs identified by the safety, tolerability, PK/PD characteristics, and preliminary efficacy data obtained from Phase Ia study.

Subjects will be orally administered GH2616 Tablet once daily in continuous 21-day cycle until the patients who have no benefits from the study judged by the Investigator, or experience disease progression, intolerable toxicity, death, loss to follow-up, withdrawal of informed consent, completion of 24 months of treatment or initiation of a new anti-tumor therapy,whichever comes first. ;

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

• NCT number: NCT06329206
• Study type: Interventional
• Source: Suzhou Genhouse Bio Co., Ltd.
• Contact: SHIYA CHEN, bachelor
• Phone: +8615618310761
• Email: chenshiya@genhousebio.com
• Status: Recruiting
• Phase: Phase 1
• Start date: March 20, 2024
• Completion date: September 1, 2026