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

NCT06007729 | Recruiting Phase 2

• 1 other identifier: HS-20093-205
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 25

Brief 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 head and neck squamous cell carcinoma and other solid tumors.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]

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

Secondary Outcomes (11)

• Incidence and severity of adverse events (AEs)

  From the first dose through 90 days post end of treatment

• Observed maximum plasma concentration (Cmax) of HS-20093

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

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

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

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

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

• Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093

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

Study Arms (1)

HS-20093 (phase 2a and Phase 2b)

EXPERIMENTAL

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

Drug: HS-20093

Interventions

HS-20093 DRUG

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

HS-20093 (phase 2a and Phase 2b)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. At least one measurable lesion according to RECIST 1.1. 4. Agree to provide fresh or archival tumor tissue and peripheral blood samples.
• \. 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.
• \. Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
• \. Signed and dated Informed Consent Form.

You may not qualify if:

• \. 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
• 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.
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (25)

Anhui Cancer Hospital

Hefei, Anhui, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Tongren Hospital, CMU

Beijing, Beijing Municipality, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Sun Yai-Sen Memorial Hospital Sun Yai-Sen University

Guangzhou, Guangdong, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

The Second XIANGYA Hospital Of Central South University

Changsha, Hunan, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

NOT YET RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

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

Shanghai, Shanghai Municipality, China

RECRUITING

The first Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Cancer hospital of Xinjiang medical University

Xinjiang, Xinjiang, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Siwei Bao

CONTACT

86-21-38804518; siwei_bao@163.com

Ye Guo, MD

CONTACT

86-21-38804518; pattrickguo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: December 18, 2023
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 12, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-07

Locations

CN (25)