ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

NCT05276609 | Unknown Phase 1

• 1 other identifier: HS-20093-101
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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 safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in Chinese advanced solid tumor patients. This is a phase 1, open-label, multi-center, dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetic (PK), and the therapeutic potential of HS-20093 as a monotherapy in subjects with advanced solid tumors.

Conditions

Advanced Solid Tumor

Keywords

Advanced solid tumor; B7-H3; antibody-drug conjugate (ADC); HS-20093

Outcome Measures

Primary Outcomes (2)

• Ⅰa (Dose-Escalation Stage): Maximum tolerated dose (MTD) for HS-20093

  To determine the MTD for further evaluation of IV administration of HS-20093 in subjects with advanced solid tumors.

  Up to day 21 from the first dose

• Ⅰb (Dose-Expansion Stage): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (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). ORR is evaluated by the number of participants with best overall response of complete response (CR) and partial response (PR) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].

  From the first dose up to PD or withdrawal from study, whichever 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 in participants with advanced solid tumor

  From pre-dose to 14 days after the first dose on Cycle 1

• 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

• 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

• 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

Study Arms (2)

HS-20093 (Phase Ia: Dose escalation)

EXPERIMENTAL

There are seven escalating dose cohorts.

Drug: HS-20093 (Phase Ia: Dose escalation)

HS-20093 (Phase Ib: Dose expansion)

EXPERIMENTAL

The recommended dose from the dose-escalation stage and other potential doses will be further explored.

Drug: HS-20093 (Phase Ib: Dose expansion)

Interventions

HS-20093 (Phase Ia: Dose escalation) 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 (Phase Ia: Dose escalation)

HS-20093 (Phase Ib: Dose expansion) DRUG

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 (Phase Ib: Dose expansion)

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;
• Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
• At 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
• 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

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
• 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
• 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

Sponsors & Collaborators

• Shanghai Hansoh Biomedical Co., Ltd: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Central Study Contacts

Jie Wang, PhD

CONTACT

13910704669; zlhuxi@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 11, 2022
• Study Start: November 28, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)