ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors

NCT06001255 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HS-20093-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 15

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. The objectives of this study are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in Chinese patients with metastasis Castration Resistant Prostate Cancer. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.

Conditions

Metastasis Castration Resistant Prostate Cancer(mCRPC)

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) determined by investigators

  Cohort 1(mCRPC): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3 (PCWG3) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. Cohort 2(Other advanced solid tumors)：Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 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 (14)

• 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.

  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 the first dose.

  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

EXPERIMENTAL

Participants will receive HS-20093 at 8 mg/kg.

Drug: HS-20093

Interventions

HS-20093 DRUG

Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

HS-20093

Eligibility Criteria

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

You may qualify if:

• Men or women greater than or equal to 18 years.
• Locally advanced or metastatic solid tumors confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable.
• At least one measurable lesion in accordance with RECIST 1.1.
• Agree to provide fresh archival tumor tissue.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
• Estimated life expectancy ≥ 12 weeks.
• 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:

• 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. Any 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.
• Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion.
• Major surgery within 4 weeks prior to the first scheduled dose of HS-20093. Spinal cord compression or brain metastases. Treatment with drugs that are predominantly strong inhibitors or inducers or sensitive substrates of CYP3A4, CYP2D6, P-gp or BCRP 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
• Patients with BRCA and ATM mutation.
• 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 alopecia or neurotoxicity
• History of other primary malignancies.
• Inadequate bone marrow reserve or organ dysfunction.
• Evidence of cardiovascular risk.
• Severe, uncontrolled or active cardiovascular diseases.
• Severe or uncontrolled diabetes, including 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (15)

Peking University Cancer Hospital

Beijing, China

RECRUITING

Hunan Cancer Hospital

Changsha, China

RECRUITING

Xiangya Hospital Central South University

Changsha, China

RECRUITING

West China hospital, sichuan university

Chengdu, China

RECRUITING

The First Affiliate Hospital of GUANGZHOU Medical University

Guangzhou, China

RECRUITING

Yunnan Cancer Hospital

Kunming, China

RECRUITING

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, China

RECRUITING

Fudan University Cancer Hospital

Shanghai, 200032, China

RECRUITING

Liaoning Tumor Hospital

Shengyang, China

RECRUITING

Shengjing Hospital of China Medical University

Shengyang, China

RECRUITING

The First Hospital of China Medical University

Shengyang, China

RECRUITING

Hubei Cancer Hospital

Wuhan, China

RECRUITING

Tongji Hospital

Wuhan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Central Study Contacts

Weijing Zhang

CONTACT

86-21-64175590; JJYIN555@163.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 14, 2023
• First Posted: August 21, 2023
• Study Start: January 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-07

Locations

CN (15)