Advanced Solid TumorPhase 1NCT05263479
A Study of HS-20089 in Patients With Advanced Solid Tumors
A Phase 1 study testing HS-20089 (Phase Ia：Dose escalation ) and HS-20089 (Phase Ib: Dose expansion) in people with Advanced Solid Tumor, run by Shanghai Hansoh Biomedical Co., Ltd at 1 site in China.
Trial summary
HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics… 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-20089 (Phase Ia：Dose escalation ) and HS-20089 (Phase Ib: Dose expansion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 31 Dec 2026
- 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
- 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 invalid, unavailable 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)
- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
- Estimated life expectancy greater than (>) 12 weeks
- Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
- Sign Informed Consent Form
Who cannot join
- Treatment with any of the following:
- Previous or current treatment with drugs targeting B7-H4
- Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
- Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
- Known and untreated, or active central nervous system metastases.
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- Existing abnormal CTCAE≥grade 2 resulted from previous treatment
- History of other malignancy
- Inadequate bone marrow reserve or organ function
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
- History of hypersensitivity to any active or inactive ingredient of HS-20089.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient 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
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Jiong Wu, PhD, 13601637369, wujiong1122@vip.sina.com
Jian Zhang, PhD, 18017312991, Syner2000@163.com
About this study
Official title: A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20089 in Patients With Advanced Solid Tumors
HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20089 in Patients With Advanced Solid Tumors.
Read the detailed description
This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20089 in patients with advanced solid tumors.
The Dose Escalation will include an initial accelerated titration design followed by a Bayesian optimal interval (BOIN) design. Enrollment into Dose Expansion will begin after identification of the MTD and/or MAD in Phase 1a. In Phase 1b, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- HS-20089 (Phase Ia：Dose escalation ), HS-20089 (Phase Ib: Dose expansion)
- Keywords
- HS-20089, ADC, B7-H4, Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20089 (Phase Ia：Dose escalation )Drug
Participants will receive HS-20089 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
HS-20089 (Phase Ib: Dose expansion)Drug
IV administration of HS-20089 Q3W; 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-20089 (Phase Ia：Dose escalation ) | Experimental | HS-20089 for IV infusion of various dose strengths administered in 21 day dosing cycles. Receives: Drug: HS-20089 (Phase Ia：Dose escalation ) |
| HS-20089 (Phase Ib: Dose expansion) | Experimental | The recommended dose from the dose-escalation stage and other potential doses will be further explored. Receives: Drug: HS-20089 (Phase Ib: Dose expansion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of HS-20089
To determine the MTD for further evaluation of IV administration of HS-20089 in subjects with advanced solid tumors.
Measured: 3 weeks after initiation of treatment
Secondary outcomes (9)
Incidence and severity of treatment-emergent adverse events
The CTCAE criteria will be used to assess adverse events on this trial.
Measured: Baseline through study completion(90 days after last dose)
Observed maximum plasma concentration (Cmax) after single dose of HS-20089
Cmax will be obtained after single dose of HS-20089 on Day 1.
Measured: From pre-dose to 120 hours after single dose on Day 1
Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-20089
Cmax ss will be obtained on Day 1 of dosing in the 21-Day cycle of therapy.
Measured: From pre-dose to 24 hours after the dose on Day 1 of the 21-Day cycle of therapy
Apparent terminal half-life (t1/2) after single dose of HS-20089
Apparent terminal half-life is the time measured for the concentration to decrease by one half.
Measured: From pre-dose to 120 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-20089
Area under the plasma concentration versus time curve from time zero to the 24-hour sampling time at which the concentration was at or above the lower limit of quantification (LLQ).
Measured: From pre-dose to 24 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) after single dose of HS-20089
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ).
Measured: From pre-dose to 120 hours after single dose on Day 1
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089
AUC0-∞ was 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 120 hours after single dose on Day 1
To further evaluation of the anti-tumor activity of HS-20089 by assessment of objective response rate (ORR)
Anti-tumor efficacy will be assessed by best radiographic response based on Response Evaluation Criteria in Solid Tumors at baseline (Day -28 to -1). For patients that continue on repeating 21-Day cycles after the primary evaluation period, progression will be assessed after each 6 weeks of therapy. ORR is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.
Measured: From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study，up to 2 years
Anti-drug Antibodies (ADA) of HS-20089
Number of participants who test positive for ADA to HS-20089 will be reported.
Measured: Baseline through study completion(90 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- 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
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hansoh Biomedical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiong Wu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263479
- Sponsor's protocol ID
- HS-20089-101
- Status last verified
- Apr 2024
- First submitted
- 29 Oct 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20089 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05263479
- Acronym / sponsor ID
- HS-20089-101
- Conditions
- Advanced Solid Tumor
- Keywords
- HS-20089, ADC, B7-H4, Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Shanghai Hansoh Biomedical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Mar 2022 (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.
HS-20089 is a novel DAR-6 antibody-drug conjugate （ADC） targeting B7-H4. In preclinical studies, it inhibited tumor cell growth expressing B7-H4 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20089 in Patients With Advanced Solid Tumors.
Detailed description
This is a Phase 1a/1b open-label, multicenter study with dose escalation and dose expansion cohorts to evaluate the safety, tolerability, PK and preliminary efficacy of HS-20089 in patients with advanced solid tumors.
The Dose Escalation will include an initial accelerated titration design followed by a Bayesian optimal interval (BOIN) design. Enrollment into Dose Expansion will begin after identification of the MTD and/or MAD in Phase 1a. In Phase 1b, preliminary efficacy will be evaluated in planned expansion cohorts that include patients with specific tumor types that are B7-H4+ advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20089 (Phase Ia：Dose escalation ) | Experimental | Drug: HS-20089 (Phase Ia：Dose escalation )HS-20089 for IV infusion of various dose strengths administered in 21 day dosing cycles. |
| HS-20089 (Phase Ib: Dose expansion) | Experimental | Drug: HS-20089 (Phase Ib: Dose expansion)The recommended dose from the dose-escalation stage and other potential doses will be further explored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 invalid, unavailable 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)
- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
- Estimated life expectancy greater than (>) 12 weeks
Key exclusion criteria (13 listed)
- Treatment with any of the following:
- Existing abnormal CTCAE≥grade 2 resulted from previous treatment
- History of other malignancy
- Inadequate bone marrow reserve or organ function
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
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-20089 (Phase Ia：Dose escalation )Participants will receive HS-20089 in 21 day dosing cycles. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression. | Drug | HS-20089 (Phase Ia：Dose escalation ) |
| HS-20089 (Phase Ib: Dose expansion)IV administration of HS-20089 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | HS-20089 (Phase Ib: Dose expansion) |
Primary outcome
Maximum Tolerated Dose of HS-20089
Time frame: 3 weeks after initiation of treatment
To determine the MTD for further evaluation of IV administration of HS-20089 in subjects with advanced solid tumors.
9 secondary outcomes
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through study completion(90 days after last dose)
Observed maximum plasma concentration (Cmax) after single dose of HS-20089
Time frame: From pre-dose to 120 hours after single dose on Day 1
Observed maximum plasma concentration (Cmax ss) after multiple dose of HS-20089
Time frame: From pre-dose to 24 hours after the dose on Day 1 of the 21-Day cycle of therapy
Apparent terminal half-life (t1/2) after single dose of HS-20089
Time frame: From pre-dose to 120 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to the 24-hour sampling time (AUC0-24) after single dose of HS-20089
Time frame: From pre-dose to 24 hours after single dose on Day 1
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) after single dose of HS-20089
Time frame: From pre-dose to 120 hours after single dose on Day 1
Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089
Time frame: From pre-dose to 120 hours after single dose on Day 1
To further evaluation of the anti-tumor activity of HS-20089 by assessment of objective response rate (ORR)
Time frame: From the date of first occurrence of complete response (CR) or partial response (PR) on 2 consecutive occasions (≥4 weeks), until the date of disease progression or withdrawal from study，up to 2 years
Anti-drug Antibodies (ADA) of HS-20089
Time frame: Baseline through study completion(90 days after 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 3 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Jiong Wu, PhD principal investigator
Fudan University
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-20089 (Phase Ia：Dose escalation ) and HS-20089 (Phase Ib: Dose expansion) in people with Advanced Solid Tumor, run by Shanghai Hansoh Biomedical Co., Ltd 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 13 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 3 Apr 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 Jiong Wu, PhD (13601637369, wujiong1122@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose of HS-20089 (time frame: 3 weeks after initiation of treatment). 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 3 Apr 2024.