Advanced Solid TumorPhase 1NCT06332170
ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
A Phase 1 study testing HS-20093, Adebrelimab and Cisplatin/ Carboplatin in people with Advanced Solid Tumor, run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents… 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-20093, Adebrelimab and Cisplatin/ Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2024to 30 May 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
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
- Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
- Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
- least one extra-cranial measurable lesion according to RECIST 1
- Agree to provide fresh or archival tumor tissue
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- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
- Life expectancy >= 12 weeks
- Agree to use medically accepted methods of contraception
- Men or women should be using adequate contraceptive measures throughout the study;
- Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
- Signed and dated Informed Consent Form
Who cannot join
- Any of the following would exclude the subject from participation in the study:
- treatment with any of the following: Previous or current treatment with B7-H3 targeted therapy Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide and cisplatin/ carboplatin Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
- Subjects with previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
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- Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093
- Subjects with current infectious diseases
- History of neuropathy or mental disorders
- Pregnant or lactating female
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
- 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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Hua Zhong, PhD, (0086)021-22200000, shsxkyy@hotmail.com
About this study
Official title: ARTEMIS-101: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients.
Read the detailed description
This is a phase 1, open-label, multi-center, dose-escalation and expansion, phase 1 study in Chinses subjects with advanced solid tumors. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents.
A total of 5 combination-treatments will be carried out in 3 cohorts. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.
- Conditions
- Advanced Solid Tumor
- Being tested
- HS-20093, Adebrelimab, Cisplatin/ Carboplatin, Cetuximab, Enzalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093Drug
administered as an IV infusion
AdebrelimabDrug
administered as an IV infusion
Cisplatin/ CarboplatinDrug
administered as an IV infusion
CetuximabDrug
administered as an IV infusion
EnzalutamideDrug
160mg once daily (QD) orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a | Experimental | HS-20093 and Adebrelimab Receives: Drug: HS-20093; Drug: Adebrelimab |
| Cohort 1b | Experimental | HS-20093, Adebrelimab and Cisplatin/ Carboplatin Receives: Drug: HS-20093; Drug: Adebrelimab; Drug: Cisplatin/ Carboplatin |
| Cohort 2a | Experimental | HS-20093 and Cetuximab Receives: Drug: HS-20093; Drug: Cetuximab |
| Cohort 2b | Experimental | HS-20093, Cetuximab and Cisplatin/ Carboplatin Receives: Drug: HS-20093; Drug: Cisplatin/ Carboplatin; Drug: Cetuximab |
| Cohort 3a | Experimental | HS-20093 and Enzalutamide Receives: Drug: HS-20093; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) for combination-treatments
To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with advanced solid tumors
Measured: Up to day 21 from the first dose
Secondary outcomes (15)
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.
Measured: From the first dose through 90 days post end of treatment
Objective response rate (ORR) determined by investigators
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat). For prostate cancer patients, ORR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3).
Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Disease control rate (DCR) determined by investigators
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose]. For prostate cancer patients, DCR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3).
Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Duration of response (DoR) determined by investigators
DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)]. For prostate cancer patients, DoR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3).
Measured: From the first dose up to PD or death, whichever came first, assessed up to 24 months
Progression-free survival (PFS) determined by investigators according to RECIST 1.1
PFS was defined as the time from random assignment or first dose to PD or death from any cause.
Measured: From the first dose up to PD or death, whichever came first, assessed up to 24 months
Overall survival (OS)
OS was defined as the time from random assignment or first dose to death from any cause.
Measured: From the first dose up to death, whichever came first, assessed up to 24 months
Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3
For prostate cancer patients, the rPFS is defined as the time from random assignment or first dose to the date of first documented PD per PCWG3 or death from any cause, whichever occurs first.
Measured: From the first dose up to PD or death from study, whichever came first, assessed up to 24 months
Time to PSA progression (TTPP)
In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks.
Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Prostate-specific cancer antigen (PSA) response rate
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Time to first subsequent therapy (TFST)
TFST was defined as the time from random assignment or first dose to the imitation of subsequent therapy or death.
Measured: From the first dose up to the imitation of subsequent therapy or death, whichever came first, assessed up to 24 months
Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor
Cmax will be obtained after administration of the first dose of HS-20093
Measured: From pre-dose to study completion, assessed up to 24 months
Time to reach maximum plasma concentration (Tmax) of HS-20093
Tmax will be obtained after administration of the first dose of HS-20093
Measured: From pre-dose to study completion, assessed up to 24 months
Terminal half-life (T1/2) of HS-20093 following the first dose
T1/2 will be obtained after administration of the first dose of HS-20093
Measured: From pre-dose to study completion, assessed up to 24 months
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093
Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
Measured: From pre-dose to study completion, assessed up to 24 months
Percentage of participants with antibodies to HS-20093 in serum
Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.
Measured: From pre-dose to study completion, assessed 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 posted27 Mar 2024
- Study start26 Apr 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 May 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 TumorStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 610 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
- NCT06332170
- Sponsor's protocol ID
- HS-20093-103
- Status last verified
- Jul 2024
- First submitted
- 18 Mar 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS-101: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06332170
- Acronym / sponsor ID
- HS-20093-103
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 27 Mar 2024 (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-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients.
Detailed description
This is a phase 1, open-label, multi-center, dose-escalation and expansion, phase 1 study in Chinses subjects with advanced solid tumors. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents.
A total of 5 combination-treatments will be carried out in 3 cohorts. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a | Experimental | Drug: HS-20093, Drug: AdebrelimabHS-20093 and Adebrelimab |
| Cohort 1b | Experimental | Drug: HS-20093, Drug: Adebrelimab, Drug: Cisplatin/ CarboplatinHS-20093, Adebrelimab and Cisplatin/ Carboplatin |
| Cohort 2a | Experimental | Drug: HS-20093, Drug: CetuximabHS-20093 and Cetuximab |
| Cohort 2b | Experimental | Drug: HS-20093, Drug: Cisplatin/ Carboplatin, Drug: CetuximabHS-20093, Cetuximab and Cisplatin/ Carboplatin |
| Cohort 3a | Experimental | Drug: HS-20093, Drug: EnzalutamideHS-20093 and Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
- least one extra-cranial measurable lesion according to RECIST 1
- Agree to provide fresh or archival tumor tissue
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
Key exclusion criteria (14 listed)
- Any of the following would exclude the subject from participation in the study:
- treatment with any of the following: Previous or current treatment with B7-H3 targeted therapy Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide and cisplatin/ carboplatin Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
- Subjects with previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
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-20093administered as an IV infusion | Drug | Cohort 1a, Cohort 1b, Cohort 2a, Cohort 2b, Cohort 3a |
| Adebrelimabadministered as an IV infusion | Drug | Cohort 1a, Cohort 1b |
| Cisplatin/ Carboplatinadministered as an IV infusion | Drug | Cohort 1b, Cohort 2b |
| Cetuximabadministered as an IV infusion | Drug | Cohort 2a, Cohort 2b |
| Enzalutamide160mg once daily (QD) orally | Drug | Cohort 3a |
Primary outcome
Maximum tolerated dose (MTD) for combination-treatments
Time frame: Up to day 21 from the first dose
To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with advanced solid tumors
15 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: From the first dose through 90 days post end of treatment
Objective response rate (ORR) determined by investigators
Time frame: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Disease control rate (DCR) determined by investigators
Time frame: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Duration of response (DoR) determined by investigators
Time frame: From the first dose up to PD or death, whichever came first, assessed up to 24 months
Progression-free survival (PFS) determined by investigators according to RECIST 1.1
Time frame: From the first dose up to PD or death, whichever came first, assessed up to 24 months
Overall survival (OS)
Time frame: From the first dose up to death, whichever came first, assessed up to 24 months
Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3
Time frame: From the first dose up to PD or death from study, whichever came first, assessed up to 24 months
Time to PSA progression (TTPP)
Time frame: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Prostate-specific cancer antigen (PSA) response rate
Time frame: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
Time to first subsequent therapy (TFST)
Time frame: From the first dose up to the imitation of subsequent therapy or death, whichever came first, assessed up to 24 months
Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor
Time frame: From pre-dose to study completion, assessed up to 24 months
Time to reach maximum plasma concentration (Tmax) of HS-20093
Time frame: From pre-dose to study completion, assessed up to 24 months
Terminal half-life (T1/2) of HS-20093 following the first dose
Time frame: From pre-dose to study completion, assessed up to 24 months
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093
Time frame: From pre-dose to study completion, assessed up to 24 months
Percentage of participants with antibodies to HS-20093 in serum
Time frame: From pre-dose to study completion, assessed 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 18 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
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-20093, Adebrelimab and Cisplatin/ Carboplatin in people with Advanced Solid Tumor, 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 12 inclusion and 14 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 Hua Zhong, PhD ((0086)021-22200000, shsxkyy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) for combination-treatments (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?
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.