Solid TumorsPhase 1NCT07834359
A Study of HS-20197 in Participants With Advanced Solid Tumors
A Phase 1 study testing HS-20197 in people with Solid Tumors, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- HS-20197
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2026to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged ≥ 18 years.
- Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
- Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
- -
Who cannot join
- Participants have received or are receiving the following treatment:
- Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.
- Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.
- Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.
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- Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.
- Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior therapies (except alopecia and residual neurotoxicity).
- Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
- Participants who are allergic to any component of HS-20197.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, PhD, (86) 020-87343468, xurh@sysucc.org.cn
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20197 in Participants With Advanced Solid Tumors
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.
Read the detailed description
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.
- Conditions
- Solid Tumors
- Being tested
- HS-20197
- Keywords
- Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20197Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia：Dose escalation | Experimental | Not described Receives: Drug: HS-20197 |
| Phase 1b Dose expansion | Experimental | Not described Receives: Drug: HS-20197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: From Day 1 to 90 days after last dose
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From the first dose until 90 days after the last dose
Concentration of anti-drug antibodies (ADAs)
Immunogenicity profile characterized by concentration of ADAs
Measured: From the first dose until 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 595 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834359
- Sponsor's protocol ID
- HS-20197-101
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20197 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07834359
- Acronym / sponsor ID
- HS-20197-101
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 595 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase Ia：Dose escalation | Experimental | Drug: HS-20197 |
| Phase 1b Dose expansion | Experimental | Drug: HS-20197 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females, aged ≥ 18 years.
- Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
- Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.
- -
Key exclusion criteria (10 listed)
- Participants have received or are receiving the following treatment:
- Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior therapies (except alopecia and residual neurotoxicity).
- Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.
- Participants who are allergic to any component of HS-20197.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20197HS-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 | Drug | Phase 1b Dose expansion, Phase Ia：Dose escalation |
Primary outcome
Maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: From Day 1 to 21 days after first dose
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
Recommended dose for expansion (RDE) of HS-20197 monotherapy
Time frame: From Day 1 to 90 days after last dose
To comprehensively evaluate the safety, pharmacokinetic profile, and preliminary clinical efficacy to determine the recommended dose for expansion (RDE).
10 secondary outcomes
Objective response rate (ORR)
Time frame: From screening to up to 3 years after last dose
Disease control rate (DCR)
Time frame: From screening to up to 3 years after last dose
Duration of response (DoR)
Time frame: From screening to up to 3 years after last dose
Progression-free survival (PFS)
Time frame: From screening to up to 3 years after last dose
Overall survival (OS)
Time frame: From screening to up to 3 years after last dose
Maximum observed concentration (C[max])
Time frame: From the first dose until 90 days after the last dose
Time to maximum concentration (Tmax)
Time frame: From the first dose until 90 days after the last dose
Area under the curve (AUC)
Time frame: From the first dose until 90 days after the last dose
Terminal half-life (t1/2)
Time frame: From the first dose until 90 days after the last dose
Concentration of anti-drug antibodies (ADAs)
Time frame: From the first dose until 90 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-20197 in people with Solid Tumors, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Xu, PhD (+86-20-87343468, xurh2@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) or maximum applicable dose (MAD) (time frame: From Day 1 to 21 days after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.