HS-20122 for adults with advanced solid tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors

This first-in-human Phase I test will try HS-20122 in adults with advanced solid tumors to find safe dosing, watch for side effects, and look for early signs it helps control tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1050 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hansoh BioMedical R&D Company (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06927570 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label Phase I multi-center study of single-agent HS-20122 in adults with locally advanced or metastatic solid tumors who have no available standard treatment options. Eligible participants must have measurable disease by RECIST 1.1 and an ECOG performance status of 0–1. Participants will receive HS-20122 and be closely monitored for safety, tolerability, pharmacokinetics, and any anti-tumor activity, with tumor assessments performed during treatment. The study is intended to characterize adverse events and dosing parameters to guide further development.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed locally advanced or metastatic solid tumors, measurable disease per RECIST 1.1, ECOG 0–1, and for whom standard treatments are unavailable, ineffective, or intolerable are the intended participants.

Not a fit: Patients with unresolved grade >2 toxicities from prior therapy, significant organ dysfunction, active cardiovascular disease, uncontrolled diabetes or hypertension, or other disqualifying conditions are unlikely to participate or benefit from this study.

Why it matters

Potential benefit: If successful, HS-20122 could become a new treatment option that controls or shrinks tumors for some patients with advanced solid tumors.

How similar studies have performed: Because this is first-in-human for HS-20122, clinical experience with this specific agent is limited, although some other early-phase targeted agents for advanced solid tumors have shown occasional promising responses in Phase I.

Eligibility criteria

Inclusion Criteria:

* Males or females, aged ≥ 18 years.
* Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors
* Standard treatment is invalid, unavailable or intolerable.
* At least 1 target lesion according to RECIST 1.1.
* ECOG PS score: 0-1.
* Estimated Life expectancy\> 12 weeks.
* Men or women should be using adequate contraceptive measures throughout the study.
* Women must have the evidence of non-childbearing potential.
* Signed and dated Informed Consent Form.

Exclusion Criteria:

* 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 alopecia or neurotoxicity
* History of other primary malignancies.
* Inadequate bone marrow reserve or organ dysfunction.
* Evidence of cardiovascular risk.
* Subjects with severe or poorly controlled diabetes.
* Subjects with severe or poorly controlled hypertension.
* Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
* Subjects with severe arteriovenous thrombotic events within 3 months.
* Subjects with severe infection within 4 weeks prior to the first dose.
* Subjects who have received steroid therapy for more than 30 days .
* Presence of known active infectious diseases.
* Presence of clinically significant gastrointestinal dysfunction.
* Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.
* Moderate to severe pulmonary diseases.
* Prior history of significant neurological or mental disorders.
* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
* Hypersensitivity to any ingredient of HS-20122.
* 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 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 alopecia or neurotoxicity
* History of other primary malignancies.
* Inadequate bone marrow reserve or organ dysfunction.
* Evidence of cardiovascular risk.
* Subjects with severe or poorly controlled diabetes.
* Subjects with severe or poorly controlled hypertension.
* Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.
* Subjects with severe arteriovenous thrombotic events within 3 months.
* Subjects with severe infection within 4 weeks prior to the first dose.
* Subjects who have received steroid therapy for more than 30 days .
* Presence of known active infectious diseases.
* Presence of clinically significant gastrointestinal dysfunction.
* Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.
* Moderate to severe pulmonary diseases.
* Prior history of significant neurological or mental disorders.
* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
* Hypersensitivity to any ingredient of HS-20122.
* 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

Guangzhou, Guangdong

• Ethics Committee of Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Ketao Chen

Conditions Advanced Solid Tumors; HS-20122