Combination therapy using HS-20093 for advanced metastatic colorectal cancer
ARTEMIS-102: a Phase Ib Study of HS-20093 Combination Therapy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Metastatic Colorectal Cancer
This study is testing a new combination treatment using HS-20093 for people with advanced metastatic colorectal cancer to see if it is safe and effective, especially for those who haven't had treatment before or who didn't respond to standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06825624 on ClinicalTrials.gov |
What this trial studies
This phase 1b clinical trial investigates the safety, tolerability, pharmacokinetics, and efficacy of HS-20093, a fully humanized antibody-drug conjugate targeting B7-H3, in combination with other anti-cancer agents for patients with advanced metastatic colorectal cancer. The study is designed as an open-label, multi-center, dose-escalation and expansion trial specifically for Chinese subjects. It includes two parts: one for patients who have progressed on or are intolerant to standard therapies, and another for those who have not received prior treatment for advanced metastatic colorectal cancer. Patients will be monitored for adverse events during treatment and for 90 days post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced metastatic colorectal cancer, either previously treated or treatment-naive.
Not a fit: Patients who have previously received B7-H3 targeted therapy or antibody-drug conjugates may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced metastatic colorectal cancer.
How similar studies have performed: Other studies have shown promise with similar antibody-drug conjugate approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least age of 18 years at screening. * Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer. 1. Dose escalation part will enroll advanced metastatic colorectal cancer patients who have progressed on or intolerant to standard therapies. 2. Dose expansion part will enroll advanced metastatic colorectal cancer patients who have not received prior treatment for advanced/metastatic colorectal cancer. * At least one measurable lesion according to RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1. * Life expectancy \>= 12 weeks. * Men or women should be using adequate contraceptive measures throughout the study. * Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. * Signed and dated Informed Consent Form. Exclusion Criteria: * Treatment with any of the following: 1. Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors as the payload 2. Any cytotoxic chemotherapy, investigational agents and small molecule targeted therapy within 14 days prior to the first scheduled dose of HS-20093 3. Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs within 28 days prior to the first scheduled dose of HS-20093 4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 5. Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion 6. Major surgery within 4 weeks of the first dose of HS-20093 7. Spinal cord compression or brain metastases. 8. Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study. 9. Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study. * Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of stable hypothyroidism treated with hormone replacement therapy, alopecia or neurotoxicity. * History of other primary malignancies. * Inadequate bone marrow reserve or organ dysfunction * Evidence of cardiovascular risk. * Severe, uncontrolled or active cardiovascular diseases. * Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug. * Severe or poorly controlled hypertension. * Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093 * Serious arteriovenous thrombosis events occurred within 3 months before the first dose. * Severe infections occurred within 4 weeks before the first dose. * Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation * The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc. * Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis. * Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function. * Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. 18\. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093 * History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins. * Hypersensitivity to any ingredient of HS-20093. * Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator * Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Ying Yuan
- Email: Yuanying1999@zju.org.cn
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.