A Study to Investigate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy With GenSci122 in Participants With Advanced Solid Tumors

NCT06772415 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GenSci122-101
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 9

Brief Summary

This is a first-in-human (FIH), multicenter, open-label, phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of GenSci122 in participants with advanced solid tumors. The study consists of 2 parts: Part 1- dose-escalation and Part 2- dose expansion. The primary endpoint of Dose escalation is To assess the safety and tolerability of GenSci122. The primary endpoint of Dose expansion is to evaluate the preliminary anti-tumor activity of GenSci122 in participants with advanced solid tumors.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose escalation: Incidence of dose-limiting toxicities (DLTs).

  2 years

• Dose expansion: Objective response rate (ORR) evaluated by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).

  3 Years

Secondary Outcomes (7)

• Incidence and severity of TEAEs.

  3 years

• Maximum Plasma Concentration (Cmax) of Gensci122

  3 years

• Time to Maximum Plasma Concentration (Tmax) of Gensci122

  3 years

• Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for Gensci122

  3 years

• Duration of Response (DOR)

  3 years

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: GenSci122 tablet 50mg; Drug: GenSci122 tablet 250mg

Interventions

GenSci122 tablet 50mg DRUG

Orally Once Daily

Single arm

GenSci122 tablet 250mg DRUG

Orally Once Daily

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent and sign the informed consent form (ICF).
• Male or female participants ≥18 years old at the time of consent.
• Meeting the requirements of tumor types shown below:
• Dose escalation:
• Participants with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
• Dose expansion:
• Participants with a histological or cytological diagnosis of recurrent or metastatic advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.
• Participants agree to provide fresh or archived tumor tissue as well as corresponding pathological report.
• Survival expectations are ≥ 12 weeks.
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 (Appendix 1).
• At least one measurable target lesion
• Participants with adequate organ function at the time of screening (requiring no blood transfusion, no use of hematopoietic stimulating factor or human albumin or use of drug for correction within 14 days before the first dose)
• All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1
• Congestive heart failure (CHF), which must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely.
• Normal QT interval on screening ECG evaluation

You may not qualify if:

• Investigational agent or anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) before the first dose of GenSci122. In addition, no concurrent investigational anti-cancer therapy is permitted.
• Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of GenSci122.
• Radiotherapy within 4 weeks before the first dose of GenSci122. Or participants have not yet recovered from acute effects of radiotherapy to baseline before the first dose of GenSci122.
• Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
• Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months before the first dose of GenSci122.
• Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required.
• Inability to swallow pills or clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of GenSci122.
• Pregnancy or lactation.
• History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma, for which by the date of the first dose of GenSci122, at least 3 years of complete remission and no other treatment is needed or expected during the study period.
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse
• Allergic to GenSci122 tablet or its components.
• Any serious illness, uncontrolled inter-current illness, psychiatric illness, or other medical history, including lab results, which in the opinion of investigator or medical monitor would be likely to impact safety or compliance with study requirements or confounds the ability to interpret the data.
• Has a treatment history of KIF18A inhibitor.
• Participants with DNA polymerase epsilon (POLE) gene hotspot mutated, or hypermutator phenotype.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (9)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The first affiliated hospital of Zhengzhou university

Zhengzhou, Henan, 45000, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

NOT YET RECRUITING

Jiang Su Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Central Study Contacts

Xi Deng

CONTACT

+86 18616809834; dengxi@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 Does escalation, Part 2 Dose expansion

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (9)