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Advanced Solid TumorsPhase 1NCT07775703

HS-20117-2 Injection in Patients With Advanced Solid Tumors

A Phase 1 study testing HS-20117-2 Injection in people with Advanced Solid Tumors, run by Hansoh BioMedical R&D Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial is a multicenter, open-label, Phase I clinical study designed to evaluate the pharmacokinetics, safety, and tolerability of HS-20117-2 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
HS-20117-2 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
13 Nov 2025to 30 Dec 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years, male or female.
  • According to RECIST v1.1, the investigator assesses that the participant has at least one target lesion.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
  • Minimum life expectancy greater than 12 weeks.
  • Female patients of childbearing potential, from signing the informed consent until 6 months after the last dose, are willing to adopt appropriate contraceptive measures and should not be breastfeeding; male patients, from signing the informed consent until 6 months after the last dose, are willing to use barrier contraception (i.e., condoms).
  • Female patients must have a negative blood pregnancy test result within 7 days prior to the first dose, or demonstrate no risk of pregnancy.
  • Voluntarily participate in this clinical trial, understand the study procedures, and be capable of providing written informed consent.

Who cannot join

  • Presence of prior anti-tumor therapy-related toxicities with a severity ≥ Grade 2 (according to CTCAE v5.0), excluding alopecia and neurotoxicity.
  • Meeting any of the following cardiac criteria:
  • Mean QT interval corrected by Fridericia's formula (QTcF) > 470 msec on resting ECG.
  • Resting ECG abnormalities indicating clinically significant rhythm, conduction, or morphological abnormalities as judged by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval > 250 msec).
  • Presence of any factor that increases the risk of QT prolongation or arrhythmic events judged by the investigator as clinically significant (e.g., heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval).
  • Left ventricular ejection fraction (LVEF) < 50%.
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  • Presence of severe, uncontrolled, or active cardiovascular or cerebrovascular diseases.
  • Severe or poorly controlled hyperglycemia.
  • Severe or poorly controlled hypertension.
  • Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose of study treatment.
  • History of severe arterial or venous thrombotic events within 3 months prior to the first dose of study treatment.
  • Ongoing or active infection within 4 weeks prior to the first dose of study treatment.
  • Current or anticipated requirement for long-term (≥ 30 days) systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) within 30 days prior to enrollment, except for patients requiring chronic inhaled corticosteroids for asthma or topical corticosteroid use. History of immunodeficiency, other acquired or congenital immunodeficiency diseases, or history of organ transplant or allogeneic bone marrow transplantation (excluding corneal transplant).
  • Presence of active infectious diseases.
  • History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.
  • Presence of interstitial lung disease (ILD). Evidence of active pneumonia on chest imaging during screening. Patients requiring long-term continuous oxygen therapy.
  • Severe neurological or psychiatric disorders that may interfere with study evaluation.
  • Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within 6 months after the last dose of the investigational product.
  • History of severe allergies, or known hypersensitivity to any component of HS-20117 or drugs in the same class as HS-20117.
  • Patients judged by the investigator as likely to have poor compliance with the study procedures and requirements.
  • Any condition that, in the investigator's judgment, jeopardizes patient safety or interferes with the study evaluation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ketao Chen contact

+86-18795500836

chenkt@hspharm.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510140

    Chengzhi Zhou, M.D., +86-13560351186, doctorzcz@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of HS-20117-2 Injection in Patients With Advanced Solid Tumors

This trial is a multicenter, open-label, Phase I clinical study designed to evaluate the pharmacokinetics, safety, and tolerability of HS-20117-2 in patients with advanced solid tumors.

Read the detailed description

This trial is a multicenter, open-label, Phase I clinical study designed to evaluate the pharmacokinetics, safety, and tolerability of HS-20117-2 in patients with advanced solid tumors. The study aims to characterize the pharmacokinetic of HS-20117-2 following subcutaneous administration and to identify a dose level that achieves PK exposure comparable to that of the recommended intravenous HS-20117 dosing regimen. By integrating the safety and tolerability data of HS-20117-2 at this dose level, the study will provide a rationale for dose selection in subsequent pivotal clinical trials of HS-20117-2.

Being tested
HS-20117-2 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20117-2 InjectionDrug

    Participants will receive subcutaneous injections of HS-20117-2 Injection

Study groups in NCT07775703
Study groupRoleWhat they receive
HS-20117-2 Injection Q2W Dosing Regimen:ExperimentalParticipants will receive subcutaneous injections once weekly (QW) during Cycle 1 (C1) for a total of 4 doses. Starting from Cycle 2 (C2), participants will transition to receiving subcutaneous injections once every two weeks (Q2W).
Receives: Drug: HS-20117-2 Injection
HS-20117-2 Injection Q3W Dosing Regimen:ExperimentalParticipants will receive subcutaneous injections once weekly (QW) during Cycle 1 (C1) for a total of 3 doses. Starting from Cycle 2 (C2), participants will transition to receiving subcutaneous injections once every three weeks (Q3W).
Receives: Drug: HS-20117-2 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of PK parameters of HS-20117: Cmax

    Maximum concentration

    Measured: Up to Day 1 of Cycle 2（once every two weeks, each cycle is 14 days） or Day 1 of Cycle 3（once every three weeks, each cycle is 21 days）

  2. Evaluation of PK parameters of HS-20117: Ctrough

    Trough concentration

    Measured: Up to Day 1 of Cycle 2（once every two weeks, each cycle is 14 days） or Day 1 of Cycle 3（once every three weeks, each cycle is 21 days）

  3. Evaluation of PK parameters of HS-20117: AUC0-14day

    Area under the plasma concentration-time curve fom time 0 to 14day

    Measured: Up to 14 days（once every two weeks）

  4. Evaluation of PK parameters of HS-20117: AUC0-21day

    Area under the plasma concentration-time curve fom time 0 to 21day

    Measured: Up to 21 days（once every three weeks）

  5. Evaluation of the safety and tolerability of HS-20117-2 Injection in patients with advanced solid tumors

    Frequency of Adverse Events

    Measured: Through study completion,up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start13 Nov 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07775703
Sponsor's protocol ID
HS-20117-2-111
Status last verified
Aug 2026
First submitted
19 Nov 2025
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20117-2 Injection 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 7 inclusion and 21 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 20 Aug 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 (+86-18795500836, chenkt@hspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of PK parameters of HS-20117: Cmax (time frame: Up to Day 1 of Cycle 2（once every two weeks, each cycle is 14 days） or Day 1 of Cycle 3（once every three weeks, each cycle is 21 days）). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07775703.

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 20 Aug 2026.

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