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Head and Neck Squamous Cell CarcinomaPhase 2NCT06007729

ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

A Phase 2 study testing HS-20093 in people with Head and Neck Squamous Cell Carcinoma, run by Hansoh BioMedical R&D Company at 25 sites 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-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
HS-20093
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
25 sitesChina
Study dates
18 Dec 2023to 12 Dec 2027
Phase
Phase 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

  • 1. At least age of 18 years at screening. 2. Patients，who have progressed on or intolerant to standard therapie，with histologically confirmed recurrent/metastatic HNSCC or other solid tumor.
  • 3. At least one measurable lesion according to RECIST 1.1. 4. Agree to provide fresh or archival tumor tissue and peripheral blood samples.
  • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1. 6. Life expectancy >= 12 weeks. 7. Men or women should be using adequate contraceptive measures throughout the study.
  • 8. Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
  • 9. Signed and dated Informed Consent Form.

Who cannot join

  • 1. Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy
  • Any cytotoxic chemotherapy, investigational agents and small molecule targeted therapy within 14 days prior to the first scheduled dose of HS-20093
  • Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs 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
  • Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion
Show all 20Show fewer
  • Major surgery within 4 weeks of the first dose of HS-20093
  • Spinal cord compression or brain metastases.
  • Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
  • Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
  • 2. Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of stable hypothyroidism treated with hormone replacement therapy, alopecia or neurotoxicity.
  • 3. History of other primary malignancies. 4. Inadequate bone marrow reserve or organ dysfunction 5. Evidence of cardiovascular risk. 6. Severe, uncontrolled or active cardiovascular diseases. 7. Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
  • 8. Severe or poorly controlled hypertension. 9. Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093 10. Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
  • 11. Severe infections occurred within 4 weeks before the first dose. 12. Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation 13. The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
  • 14. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
  • 15. Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
  • 16. Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment.
  • 17. Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
  • 18. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093 19. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
  • 20. Hypersensitivity to any ingredient of HS-20093. 21. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator 22. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Trial locations and contacts

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

Siwei Bao contact

86-21-38804518 ext. 22198

siwei_bao@163.com

Ye Guo, MD contact

86-21-38804518 ext. 22229

pattrickguo@gmail.com

25 sites in 1 country

China25 sites, 25 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing Municipality

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Recruiting

  • The Second XIANGYA Hospital Of Central South University

    Changsha, Hunan

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Recruiting

  • Sun Yai-Sen Memorial Hospital Sun Yai-Sen University

    Guangzhou, Guangdong

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Recruiting

  • Anhui Cancer Hospital

    Hefei, Anhui

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan, Shandong

    Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Ye Guo, MD, 13501678472, pattrickguo@gmail.com

    Recruiting

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, Shanghai Municipality

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Recruiting

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

    Wuhan, Hubei

    Recruiting

  • The first Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Recruiting

  • Cancer hospital of Xinjiang medical University

    Xinjiang, Xinjiang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong

    Recruiting

Other trials in China

About this study

Official title: ARTEMIS-006: A Phase 2 Study to Evaluate Efficacy and Safety of Intravenous Administration of HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other 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.

This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with head and neck squamous cell carcinoma and other solid tumors.

Read the detailed description

This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and 2b.

Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) who have progressed on or intolerant to standard therapies. Cohort 2: Other patients with advanced solid tumors if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. All subjects will receive 10.0 mg/kg of HS-20093.

Phase 2b: The study will be conducted in patients with recurrent/metastatic HNSCC who have progressed on or intolerant to standard therapies. Subjects will receive 10.0 mg/kg of HS-20093.

All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Being tested
HS-20093
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • HS-20093Drug

    Participants in all subjucts will receive HS-20093 at 10mg/kg

Study groups in NCT06007729
Study groupRoleWhat they receive
HS-20093 (phase 2a and Phase 2b)ExperimentalParticipants in all subjects will receive HS-20093 at 10mg/kg
Receives: Drug: HS-20093

What is being measured

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

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

    ORR was 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 version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)]

    Measured: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 24 months

Secondary outcomes (11)

  1. 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

  2. Observed maximum plasma concentration (Cmax) of HS-20093

    Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle

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

  3. Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose in participants with advanced solid tumor

    Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle

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

  4. Terminal half-life (T1/2) of HS-20093 following IV dose in participants with advanced solid tumor

    Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz

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

  5. 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 14 days after the first dose on Cycle 1 (each cycle is 21 days)

  6. 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 90 days post end of treatment

  7. ORR determined by Independent review committee (IRC) according to RECIST 1.1

    ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by IRC based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)]

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

  8. Duration of response (DoR) determined by investigators and IRC according to RECIST 1.1

    DoR was defined as the period from the first occurrence of CR or PR to progressive disease (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)]

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

  9. Disease control rate (DCR) determined by investigators and IRC according to RECIST 1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). 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]

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

  10. Progression-free survival (PFS) determined by investigators and IRC according to RECIST 1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause

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

  11. Overall survival (OS)

    OS was defined as the time from the first dose or random assignment (if any) to death from any cause

    Measured: From the first dose or random assignment up to death or withdrawal from study, whichever came first, 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.

  1. First posted23 Aug 2023
  2. Study start18 Dec 2023
  3. Primary completion12 Dec 2025 (estimated)
  4. Study completion12 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06007729
Sponsor's protocol ID
HS-20093-205
Status last verified
Jul 2024
First submitted
17 Aug 2023
Last updated
20 Aug 2024
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 2 study testing HS-20093 in people with Head and Neck Squamous Cell Carcinoma, run by Hansoh BioMedical R&D Company at 25 sites 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 5 inclusion and 20 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 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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 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 Siwei Bao (86-21-38804518 ext. 22198, siwei_bao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 24 months). 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 NCT06007729.

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 2024.

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