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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. | Clinical Trials | Clareo Health

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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•Suzhou Genhouse Bio Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- 1.Female, aged ≥18 years. 2.Assessed by the investigator as suitable for participation in this study in the following two aspects: a. The subject fully understands the requirements of this study and voluntarily signs a written informed consent form; b. Can comply with the medication requirements of this study and all study-related procedures and assessments.
•3.Tumor types meeting the following conditions:
•Phase Ia:
•Subjects with relapsed or metastatic advanced gynecological tumors and triple-negative breast cancer (TNBC) confirmed by histology or cytology and laboratory-confirmed functional loss mutation of TP53, including but not limited to high-grade serous ovarian cancer (HGSOC), uterine carcinosarcoma (UCS), endometrial cancer (EC) and other gynecological tumors, and TNBC.
•Phase Ib:
•Subjects with relapsed or metastatic advanced gynecological tumors and TNBC confirmed by histology or cytology and laboratory-confirmed functional loss mutation of TP53 and genomic doubling (WGD) characteristics, including but not limited to HGSOC, UCS, EC and other gynecological tumors, and TNBC. Specific requirements for each tumor type are as follows:
•1. High-grade serous ovarian cancer: Platinum-resistant ovarian cancer that has progressed/relapsed after at least one line of platinum-containing chemotherapy, or platinum-sensitive ovarian cancer that has progressed/relapsed after at least two lines of platinum-containing chemotherapy. The definition of "platinum-resistant" is: the interval between the discovery of tumor recurrence and the last chemotherapy of the previous platinum-containing regimen is \<6 months, or the tumor progresses during initial treatment or recurrence treatment. The definition of "platinum-sensitive" is: the interval between the discovery of tumor recurrence and the last chemotherapy is ≥6 months. The interval should be calculated from the date of the last platinum drug treatment to the date of disease progression.
•2. Uterine carcinosarcoma: Progressed/relapsed after at least one line of platinum-containing chemotherapy.
•3. Endometrial cancer: Progressed/relapsed after at least one line of platinum-containing chemotherapy.
•4. TNBC: Progressed/relapsed after at least one line of chemotherapy. Note: Subjects receiving adjuvant therapy who have disease progression within less than 6 months after the end of treatment can be considered as having received first-line therapy.
+29 more criteria

Exclusion Criteria

•1.Received chemotherapy within 21 days before the first administration of GH2616 tablets, or received radiotherapy, endocrine therapy, immunotherapy and other anti-tumor drug treatments within 28 days before, and special regulations are made for the following anti-tumor drugs or treatments:
•1. Nitrosourea or mitomycin C: within 6 weeks before the first use of the study drug;
•2. Oral fluoropyrimidines, small molecule targeted drugs, and traditional Chinese medicine with anti-tumor indications: within 5 half-lives or 14 days before the first use of the study drug (whichever is shorter);
•3. Local palliative radiotherapy: within 14 days before the first use of the study drug.
•2.Received other unmarketed clinical research drugs or treatments within 28 days before the first administration.

Locations (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 27, 2025

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2030

Last Updated

December 3, 2025

Enrollment

126

ESTIMATED participants

Conditions

Advanced Solid Tumor Cancer

Interventions

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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