A Phase 1 interventional study of HS-20197 in Solid Tumors, sponsored by Hansoh BioMedical R&D Company. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Hansoh BioMedical R&D Company (part of Hansoh Pharmaceutical Group Company Limited) · Phase 1, Interventional, and Treatment
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.
This is a multicenter, open-label, Phase I study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of intravenously administered HS-20197 in participants with advanced solid tumors. The study comprises a Phase Ia dose-escalation phase followed by a Phase Ib dose-expansion phase.
Hansoh BioMedical R&D Company is the lead sponsor of 48 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants have at least 1 target lesion other than CNS lesions according to 1.1.
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Exclusion Criteria:
Participants have received or are receiving the following treatment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HS-20197
Drug: HS-20197
HS-20197 (Phase Ia：Dose escalation ) * HS-20197 for IV infusion of various dose strengths administered in 21 day dosing cycles HS-20197 (Phase Ib:Dose expansion ) * The recommended dose from the dose-escalation stage and other potential doses will be further explored
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
RDE will be determined using DLTs and number of participants with treatment-related adverse events as assessed by CTCAE v6.0 and preliminary clinical efficacy
Time frame: From Day 1 to 21 days after first dose
Recommended dose for expansion (RDE) of HS-20197 monotherapy
To comprehensively evaluate the safety, pharmacokinetic profile, and preliminary clinical efficacy to determine the recommended dose for expansion (RDE).
Time frame: From Day 1 to 90 days after last dose
Objective response rate (ORR)
Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1
Time frame: From screening to up to 3 years after last dose
Disease control rate (DCR)
Defined as the proportion of participants with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1
Time frame: From screening to up to 3 years after last dose
Duration of response (DoR)
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: From screening to up to 3 years after last dose
Progression-free survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first
Time frame: From screening to up to 3 years after last dose
Overall survival (OS)
Time from date of start of treatment to death from any cause
Time frame: From screening to up to 3 years after last dose
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of HS-20197
Time frame: From the first dose until 90 days after the last dose
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of HS-20197
Time frame: From the first dose until 90 days after the last dose
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of HS-20197
Time frame: From the first dose until 90 days after the last dose
Terminal half-life (t1/2)
Pharmacokinetic profile characterized by the terminal half-life (t1/2) of HS-20197
Time frame: From the first dose until 90 days after the last dose
Concentration of anti-drug antibodies (ADAs)
Immunogenicity profile characterized by concentration of ADAs
Time frame: From the first dose until 90 days after the last dose
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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