NCT06329206

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

A Phase Ia/Ib Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH2616 Tablet in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Suzhou Genhouse Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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. 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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GH2616 Tablets	GH2616 tablets will be given orally

Timeline

• Start date: 2024-03-20
• Primary completion: 2026-04-25
• Completion: 2026-09-01
• First posted: 2024-03-25
• Last updated: 2024-07-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study