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A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GH2616 in Subjects With Advanced Solid Tumor.

NCT07260513 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-12-03

No results posted yet for this study

Summary

GH2616 is a potent and selective inhibitor targeting KIF18A, exhibiting distinct and superior anticancer properties compared to other cell cycle and anti-mitotic drug targets, with significant inhibitory effects on TP53 mutant and WGD (whole genome doubling) or CIN (chromosomal instability) tumors. GH2616 regulates chromosome distribution and alignment, prolongs mitotic duration, and activates the spindle assembly checkpoint by inhibiting KIF18A activity, thereby arresting mitosis at the G2/M phase, inducing mitotic catastrophe, and ultimately achieving tumor suppression.

This study will evaluate the safety and tolerability of GH2616 in patients with advanced solid tumors, and determine its dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D).

Conditions

  • Advanced Solid Tumor Cancer

Interventions

DRUG

GH2616 Tablets for oral administration at specified doses on scheduled days.

Drug: GH2616 Treatment group: Subjects will receive GH2616 orally in a dose escalation until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the study.

Sponsors & Collaborators

  • GCP ClinPlus Co., Ltd.

    collaborator UNKNOWN

  • Jiaxing Yidixi Computer Technology Co., Ltd

    collaborator UNKNOWN

  • Nanjing CR Medicon Technology Co., Ltd.

    collaborator UNKNOWN

  • Nanjing Shihejiyin Technology, Inc.

    collaborator INDUSTRY

  • Fudan University

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Suzhou Genhouse Bio Co., Ltd.

    lead OTHER

Principal Investigators

  • QIAN DONG, MASTER · Suzhou Genhouse Bio Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260513 on ClinicalTrials.gov