Advanced Solid TumorsPhase 1NCT06927570
A Study of HS-20122 in Patients With Advanced Solid Tumors
A Phase 1 study testing HS-20122 in people with Advanced Solid Tumors, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HS-20122
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 30 Jun 2028
- 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.
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 37Show fewer
- 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
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, 1 recruiting
- Recruiting
Ethics Committee of Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Xuzhi Pan, 020-87343009, llwyh@sysucc.org.cn
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- HS-20122
- Keywords
- Advanced Solid Tumors, HS-20122
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20122Drug
Intravenous (IV) administration of HS-20122 ; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
| Study group | Role | What they receive |
|---|---|---|
| HS-20122 | Experimental | All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage Receives: Drug: HS-20122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors
Measured: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
Secondary outcomes (8)
Incidence and severity of adverse events (AEs)
Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.
Measured: From time of Informed Consent to 28 days post last dose of HS-20122
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Measured: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
The Cmax is the maximum observed drug concentration of HS-20122
Measured: From the date of first dose until 30 days after the final dose
Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
The Tmax is defined as time to reach maximum observed drug concentration of HS-20122.
Measured: From the date of first dose until 30 days after the final dose.
Area under the curve from time Zero to end of dosing interval (AUC0-t) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
The AUC0-t is defined as the area under the drug concentration-time curve during a dose interval time period(t)
Measured: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.
Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
The AUC0-∞ is defined as the area under the drug concentration-time curve from time 0 to infinity
Measured: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose
Incidence of anti-HS-20122 antibody (ADA)
ADA incidence was defined as the percentage of participants whose ADA status were identified as positive.
Measured: From the date of first dose until 30 days after the final dose.
Objective response rate (ORR)
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Apr 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,050 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
- NCT06927570
- Sponsor's protocol ID
- HS-20122-101
- Status last verified
- Jan 2026
- First submitted
- 7 Apr 2025
- Last updated
- 16 Jan 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06927570
- Acronym / sponsor ID
- HS-20122-101
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, HS-20122
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Apr 2025 (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 a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-20122 | Experimental | Drug: HS-20122All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (37 listed)
- 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.
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-20122Intravenous (IV) administration of HS-20122 ; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | HS-20122 |
Primary outcome
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
Time frame: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors
8 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: From time of Informed Consent to 28 days post last dose of HS-20122
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
Observed maximum drug concentration (Cmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the date of first dose until 30 days after the final dose
Time to reach maximum observed drug concentration (Tmax) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the date of first dose until 30 days after the final dose.
Area under the curve from time Zero to end of dosing interval (AUC0-t) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose.
Area under the curve from time Zero to end of dosing interval (AUC0-∞) of HS-20122 (including antibody-drug conjugates, total antibody, and payload)
Time frame: From the date of first dose to Cycle 4(each cycle is 28 days) pre-dose
Incidence of anti-HS-20122 antibody (ADA)
Time frame: From the date of first dose until 30 days after the final dose.
Objective response rate (ORR)
Time frame: up to 24 months
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 16 Jan 2026.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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-20122 in people with Advanced 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 9 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 16 Jan 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 Ketao Chen (18795500836, chenkt@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose (MTD) or the maximum applicable dose (MAD) (time frame: From time of first dose of HS-20122 to end of DLT period (approximately 21 days)). 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 16 Jan 2026.