Clinical trial NCT06963502: A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
Official title: A Phase Ib Study Evaluating the Safety, Tolerability , Pharmacokinetics，Activity and Immunogenicity of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Colorectal Cancer
Non-Small Cell Lung Cancer
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-09
Enrollment: 762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase Ib study that will evaluate the Safety, Tolerability , Pharmacokinetics, Activity and Immunogenicity of HS-10370 in Combination With Other Anti-cancer Therapies in Chinese patients with KRAS G12C mutation advanced or metastatic solid tumors, especially in and Colorectal cancer(CRC) and non-Small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Men or women greater than or equal to 18 years
* At least one measurable lesion in accordance with RECIST 1.1
* Must have an ECOG performance status of 0 or 1.
* Patients with advanced solid tumors who have failed after adequate standard treatment, are intolerant to standard treatment, or have no standard treatment available.
* Documentation of the presence of a KRAS G12C mutation
* Estimated life expectancy ≥12 weeks.
* Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose.Men also consent to use adequate contraceptive method within the same time limit.
* The subjects are able to comply with the process of the protocol.

Exclusion Criteria:

* Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
* Active brain metastases.
* Patients with uncontrolled pleural, ascites or pericardial effusion
* Spinal cord compression
* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
* Subjects with tumors known to harbor molecular alterations for which targeted therapy is locally approved, except for KRAS G12C.
* History of other primary malignancies.
* Inadequate bone marrow reserve or organ functions.
* Abnormal cardiac examination results.
* Severe, uncontrolled or active cardiovascular disorders.
* Diabetes ketoacidosis or hyperglycemia hyperosmolality
* Uncontrolled hypertension.
* Severe bleeding symptoms or bleeding tendencies.
* Severe arteriovenous thrombosis occurred
* Serious infection.
* Continuous use of glucocorticoids
* Active infectious diseases.
* Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications
* Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
* Interstitial lung disease (ILD).
* Serious neurological or mental disorders.
* Active autoimmune diseases

Primary outcomes:
measure: Number of Participants with Adverse Event(s) (AEs)
timeFrame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
measure: Disease Control Rate (DCR)
timeFrame: From Cycle 1 Day 1 (C1D1) to disease progression or death, up to 2 years (each cycle is 14 days).
measure: Time to Response (TTR)
timeFrame: Time from Cycle 1 Day 1 until the date that measurement criteria for CR or PR (whichever is first recorded) are first met, up to 2 years (each cycle is 14 days).
measure: Duration of Response (DOR)
timeFrame: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Date of first evidence of CR or PR to date of disease progression or death from any cause, approximately 2 years
measure: Overall survival (OS)
timeFrame: Cycle 1 Day 1 to date of death from any cause, up to 5 years (each cycle is 14 days)
measure: Plasma Concentrations of HS-10370
timeFrame: Cycle 1 Day 1 to date of death from any cause. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation, up to 2 years. (each cycle is 14 days)
measure: Maximum plasma concentration (Cmax)
timeFrame: Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days)
measure: Time of maximum concentration (Tmax)
timeFrame: Cycle 1 Day 1 to date of death from any cause, up to 2 years. Various timepoints from Cycle 1 Day 1 through study treatment discontinuation (each cycle is 14 days)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Shanghai
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References: