NCT06963502Not yet recruitingPhase 1
A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 9 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 762 (estimated)
- First submitted
- 16 Apr 2025
- Start date
- 30 May 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT06963502
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 762
- From 30 May 2025 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any of the following: Previous or current treatment with other KRAS G12C inhibitors.
- 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.
Other illness
- History of other primary malignancies.
- 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.
- 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
Other
- Active brain metastases.
- Patients with uncontrolled pleural, ascites or pericardial effusion
- Spinal cord compression
- Inadequate bone marrow reserve or organ functions.
- Continuous use of glucocorticoids
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.