AzTrials
AzTrials

Advanced Solid TumorPhase 1/2NCT06144723

Study of HS-20105 for Injection in Patients With Advanced Solid Tumors.

A Phase 1/2 study testing HS-20105 in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

HS-20105 is a novel antibody-drug conjugate (ADC) targeting Trop-2. This first-in-human trial is aimed to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics (PK), safety and preliminary anti-tumor activity of HS-20105 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS-20105
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Mar 2027
Phase
Phase 1/2
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

  • Men or women aged more than or equal to (≥) 18 years.
  • Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is failed or intolerable.
  • Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required). Patients with only brain and/or bone lesions as target lesions will not be included.
  • Fresh or archived tumor tissue samples need to be provided (fresh samples are preferred, and tumor tissue samples within 2 years before the first administration can be accepted; the sample type is formalin fixed, paraffin embedded [FFPE] tumor tissue block or FFPE slides).
  • ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
  • Estimated life expectancy greater than (>) 12 weeks.
Show all 9Show fewer
  • Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
  • Females must have the evidence of non-childbearing potential.
  • Sign informed consent form.

Who cannot join

  • Has received or is currently undergoing the following treatment:
  • Previously or current treatment with drugs targeting Trop-2 or other ADC drugs conjugated with HS-9265;
  • Received traditional Chinese medicine therapy with anti-tumor indications within 2 weeks prior to the first administration of HS-20105;
  • Received cytotoxic chemotherapy drugs or other anti-tumor system therapies (including endocrine therapy, molecular targeted therapy, or biological therapy) within 3 weeks prior to the first administration of HS-20105;
  • Received macromolecular anti-tumor drugs or experimental drug therapy within 4 weeks before the first administration of HS-20105;
  • Received local radiotherapy within 2 weeks before the first administration of HS-20105; Received more than 30% of bone marrow irradiation or extensive radiation therapy within 4 weeks before the first administration of HS-20105;
Show all 30Show fewer
  • Received major surgery within 4 weeks before the first administration of HS-20105.
  • Received strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp or BCRP, or drugs with narrow treatment windows for CYP3A4, CYP2D6, P-gp or BCRP sensitive substrates, have been used.
  • Receiving medication that is known to prolong the QT interval or may lead to torsade de pointes.
  • Existing abnormal CTCAE ≥ grade 2 resulted from previous treatment.
  • History of other malignancy.
  • Uncontrolled pleural, ascites or pericardial effusion.
  • Known and unstable central nervous system metastases.
  • Inadequate bone marrow reserve or serious organ dysfunction.
  • Severe, uncontrolled, or active cardiovascular disease.
  • Severe or poorly controlled diabetes.
  • Severe or poorly controlled hypertension.
  • Clinically significant bleeding symptoms within 1 month before the first administration of HS-20105.
  • Serious thrombosis events within 3 months before the first administration of HS-20105.
  • Serious infection within 4 weeks before the first administration of HS-20105.
  • Received continuous glucocorticoid treatment for more than 7 days within 28 days before the first administration of HS-20105.
  • Active infectious disease.
  • Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh B-grade cirrhosis.
  • Serious or uncontrolled eye disease.
  • Moderate to severe lung diseases that may interfere with the detection or management of drug-related pulmonary toxicity and seriously affect respiratory function.
  • Severe neurological or mental disorders that can interfere with assessment.
  • Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
  • History of hypersensitivity to any active or inactive ingredient of HS-20105.
  • The subject who is unlikely to comply with study procedures, restrictions, or requirements, judged by the investigator
  • The subject whose safety cannot be ensured or study assessments would be interfered, judged by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Binghe Xu, PhD contact

86-10-87788495

xubinghe@csco.org.cn

About this study

Official title: Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic and the Therapeutic Potential of HS-20105 for Injection in Patients With Advanced Solid Tumors.

HS-20105 is a novel antibody-drug conjugate (ADC) targeting Trop-2. This first-in-human trial is aimed to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics (PK), safety and preliminary anti-tumor activity of HS-20105 in patients with advanced solid tumors.

Read the detailed description

This is a multicenter, open-label Phase I clinical study evaluating the safety, tolerability, PK, and efficacy of HS-20105 in patients with advanced solid tumors. The study includes Phase Ia (dose escalation) and Phase Ib (dose extension). Phase Ia will conduct a dose escalation using the "Rolling 6" design in advanced solid tumor patients who have failed or are unable to tolerate standard treatment, to evaluate the safety, tolerability, PK characteristics, and efficacy of HS-20105. The subsequent Phase Ib study will be conducted in certain population to evaluate the preliminary efficacy of HS-20105 at different doses and in different populations.

Being tested
HS-20105
Keywords
Advanced Solid Tumor, HS-20105, Trop-2, ADC

What participants receive

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

  • HS-20105Drug

    Administered intravenously every 21 days.

Study groups in NCT06144723
Study groupRoleWhat they receive
HS-20105 Phase Ia (Dose escalation)ExperimentalPatients with advanced solid tumors will be enrolled and receive HS-20105 of various dose strengths until the end of the study in the absence of unacceptable toxicities and disease progression.
Receives: Drug: HS-20105
HS-20105 Phase Ib (Dose expansion)ExperimentalDepending on data obtained from the dose escalation, dose expansion may proceed with multiple cohorts in subjects with advanced solid tumors. Patients enrolled will receive HS-20105 until the end of the study in the absence of unacceptable toxicities and disease progression. The recommended doses from the dose escalation will be further explored.
Receives: Drug: HS-20105

What is being measured

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

  1. Phase Ia: MTD or maximum applicable dose (MAD) of HS-20105

    Number of participants with DLT.

    Measured: Up to12 months.

  2. Phase Ib: Efficacy of HS-20105

    Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

    Measured: Up to 24 months.

Secondary outcomes (10)

  1. Incidence and severity of treatment-emergent adverse events

    Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Up to 36 months.

  2. Disease control rate (DCR)

    The percentage of patients who have achieved complete response, partial response, and stable disease, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

    Measured: Up to 24 months.

  3. Duration of response (DoR)

    The time from complete or partial response to disease progression or death, according to response evaluation criteria in solid tumors (RECIST) 1.1 by investigator's assessment.

    Measured: Up to 24 months.

  4. Progression-free survival (PFS)

    Progression free survival is defined as the duration of time from study entry to time of progression, death, or is censored at date of last disease assessment.

    Measured: Up to 24 months.

  5. Overall survival (OS)

    Overall survival is defined as the duration of time from study entry to death or the date of last contact.

    Measured: Up to 3 years

  6. Maximum plasma concentration (Cmax)

    Cmax is defined as maximum observed serum concentration obtained directly from the observed concentration-time data.

    Measured: Up to 24 months.

  7. Time of maximum concentration (Tmax)

    Tmax is defined as the time required for a drug to reach peak concentration in plasma.

    Measured: Up to 24 months.

  8. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t)

    Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration.

    Measured: Up to 24 months.

  9. Elimination half-life (T1/2)

    T1/2 is defined as apparent terminal elimination half-life (h).

    Measured: Up to 24 months.

  10. Anti-drug antibodies (ADA) of HS-20105

    Number of participants who are positive for ADA will be reported..

    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.

  1. First posted22 Nov 2023
  2. Study start1 Mar 2024 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completion1 Mar 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
402 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06144723
Sponsor's protocol ID
HS-20105-101
Status last verified
Nov 2023
First submitted
10 Nov 2023
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HS-20105 in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company.

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 30 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Binghe Xu, PhD (86-10-87788495, xubinghe@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: MTD or maximum applicable dose (MAD) of HS-20105 (time frame: Up to12 months.). 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?

On the ClinicalTrials.gov record for NCT06144723.

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 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in