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Advanced Solid TumorsPhase 1NCT06336707

HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

A Phase 1 study testing HS-20089, Adebrelimab and Bevacizumab 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
Search all trials

Trial summary

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6. 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-20089, Adebrelimab and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,048 participants
Where
1 siteChina
Study dates
11 Apr 2024to 8 Apr 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 or older (≥18 years).
  • Patients diagnosed with pathologically confirmed advanced solid tumors.
  • Subjects have at least one target lesion as assessed per the RECIST 1.1. Patients with only brain and/or bone lesions as target lesions are ineligible.
  • Agree to provide fresh or archival tumor tissue
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
  • Have a life expectancy of at least 12 weeks.
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  • Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.
  • Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin [HCG], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.
  • Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.

Who cannot join

  • Have received or is currently receiving the following treatment: B7-H4-targeted therapies; Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
  • Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
  • Presence of pleural/abdominal effusion requiring clinical intervention.
  • Known history of other primary malignancy.
  • Evidence of brain metastasis and/or cancerous meningitis
  • Inadequate bone marrow reserve or hepatic/renal functions.
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  • Cardiological examination abnormality.
  • Severe, uncontrolled or active cardiovascular disorders.
  • Serious or poorly controlled diabetes.
  • Serious or poorly controlled hypertension.
  • Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.
  • Serious infections within 4 weeks prior to the first dose.
  • Have received systemic glucocorticoid therapy for more than 7 days within 28 days prior to the first dose study treatment, or require chronic (≥ 7 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.
  • Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.
  • Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.
  • Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
  • History of severe neurological or psychiatric disorder.
  • Pregnant or breast-feeding women or women who intend to become pregnant during the study.
  • Attenuated live vaccination within 4 weeks prior to the first dose.
  • Subjects with autoimmune disease that is active or is likely to recur.
  • Subjects with gastrointestinal fistula, visceral fistula, gastrointestinal perforation, or abdominal abscess, or with symptoms/signs of intestinal obstruction within 6 months prior to the first dose of study drug.
  • Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.
  • Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.

Trial locations and contacts

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

Ding Ma, PhD contact

(0086)13886090620

dma@tjh.tjmu.edu.cn

China1 site, 1 recruiting

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Shanghai, Shanghai Municipality, 430000

    Ding Ma, PhD, (0086)13886090620, dma@tjh.tjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.

This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors.

Read the detailed description

This study contains four combination therapy cohorts, each consisting of a dose exploration part and a dose expansion part.

The dose exploration part will explore the corresponding optimal dose level of HS-20089 in each combination therapy. The dose expansion part will be conducted at 1 or 2 safe and potentially effective dose levels in subjects with selected tumors in each cohort.

The cohorts may be adjusted based on the observed clinical results, translational medicine data and research progress in the field.

Being tested
HS-20089, Adebrelimab, Bevacizumab, Cisplatin / carboplatin
Keywords
HS-20089, B7-H4, Antibody-drug Conjugate, Combination Therapy

What participants receive

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

  • HS-20089Drug

    Intravenous infusion

  • AdebrelimabDrug

    Intravenous infusion

  • BevacizumabDrug

    Intravenous infusion

  • Cisplatin / carboplatinDrug

    Intravenous infusion

Study groups in NCT06336707
Study groupRoleWhat they receive
HS-20089 and AdebrelimabExperimentalNot described
Receives: Drug: HS-20089; Drug: Adebrelimab
HS-20089, Adebrelimab and cisplatin / carboplatinExperimentalNot described
Receives: Drug: HS-20089; Drug: Adebrelimab; Drug: Cisplatin / carboplatin
HS-20089 and BevacizumabExperimentalNot described
Receives: Drug: HS-20089; Drug: Bevacizumab
HS-20089, Bevacizumab and cisplatin / carboplatinExperimentalNot described
Receives: Drug: HS-20089; Drug: Bevacizumab; Drug: Cisplatin / carboplatin

What is being measured

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

  1. Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy

    To determine the MTD or MAD of HS-20089 in each combination therapy.

    Measured: Up to day 21 from the first dose

Secondary outcomes (11)

  1. Incidence and severity of adverse events (AEs)

    AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.

    Measured: From the first dose to 90 days after the end of treatment

  2. Observed maximum plasma concentration (Cmax) of HS-20089

    Cmax will be obtained following administration of the first dose of HS-20089 during the first cycle.

    Measured: From pre-dose to 14 days after the first dose of HS-20089 on Cycle 1 (each cycle is 21 days).

  3. Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose

    Tmax will be obtained following administration of the first dose of HS-20089 during the first cycle.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).

  4. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089

    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration is no less than the lower limit of quantification (LLQ). AUC0-t will be calculated according to the mixed log-linear trapezoidal rule.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).

  5. Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089

    AUC0-∞ will be calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).

  6. Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    ORR is 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 RECIST 1.1.

    Measured: From the first dose up to disease progression or withdrawal from study, whichever came first (assessed up to 24 months).

  7. Duration of response (DoR) assessed by investigators according to RECIST 1.1

    DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death of any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) will be used.

    Measured: From the first dose to disease progression or withdrawal from study, whichever came first (assessed up to 24 months).

  8. Disease control rate (DCR) assessed by investigators according to RECIST 1.1

    DCR is defined as the percentage of participants with BOR of confirmed CR, PR and stable disease (SD).

    Measured: From the first dose to disease progression or withdrawal from study, whichever came first (assessed up to 24 months).

  9. Progression-free survival (PFS) assessed by investigators according to RECIST 1.1

    PFS is defined as the time from first dose or randomization (if any) to PD or death of any cause.

    Measured: From the first dose or randomization to disease progression or withdrawal from study, whichever came first (assessed up to 24 months).

  10. Overall survival (OS)

    OS is defined as the time from the first dose or randomization (if any) to death of any cause.

    Measured: From the first dose or randomization to death or withdrawal from study, whichever came first, assessed up to 24 months.

  11. Percentage of participants with antibodies to HS-20089 in serum

    Serum samples will be collected for the determination of anti-drug antibody (ADA) at designated time points.

    Measured: From the first dose to 90 days after the end of treatment.

Timeline

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

  1. First posted29 Mar 2024
  2. Study start11 Apr 2024
  3. Primary completion8 Apr 2026 (estimated)
  4. Study completion8 Apr 2028 (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
1,048 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06336707
Sponsor's protocol ID
HS-20089-103
Status last verified
Jul 2024
First submitted
20 Mar 2024
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20089, Adebrelimab and Bevacizumab 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 23 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 18 Jul 2024. 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 Ding Ma, PhD ((0086)13886090620, dma@tjh.tjmu.edu.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) of HS-20089 in combination therapy (time frame: Up to day 21 from the first dose). 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 NCT06336707.

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 18 Jul 2024.

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