ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer

NCT06825624 | Recruiting Phase 1

• 1 other identifier: HS-20093-105
• Study Type: interventional
• Target: 560
• 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 efficacy of HS-20093 in combination with other anti-cancer agents in patients with advanced metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer (CRC)

Keywords

Metastatic Colorectal Cancer (mCRC); B7-H3; antibody-drug conjugate (ADC); HS-20093

Outcome Measures

Primary Outcomes (1)

• 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 metastatic colorectal cancer

  Up to day 21 (arm 1/3/4) or 28 (arm 2/5) from the first dose

Secondary Outcomes (11)

• Incidence and severity of adverse events (AEs)

  From the first dose through 90 days post end of treatment

• Objective response rate (ORR) determined by investigators

  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

  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

  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

  From the first dose up to PD or death, whichever came first, assessed up to 24 months

Study Arms (5)

Arm1

EXPERIMENTAL

HS-20093 and Bevacizumab

Drug: HS-20093; Drug: Bevacizumab

Arm 2

EXPERIMENTAL

HS-20093, Bevacizumab and 5-fluorouracil (5-FU), Leucovorin

Drug: HS-20093; Drug: Bevacizumab; Drug: 5-FU; Drug: Leucovorin

Arm 3

EXPERIMENTAL

HS-20093, Bevacizumab and 5-fluorouracil (5-FU)

Drug: HS-20093; Drug: Bevacizumab; Drug: 5-FU

Arm 4

EXPERIMENTAL

HS-20093, Bevacizumab and capecitabine

Drug: HS-20093; Drug: Bevacizumab; Drug: Capecitabine

Arm 5

EXPERIMENTAL

HS-20093, Bevacizumab, Oxaliplatin and 5-fluorouracil (5-FU), Leucovorin

Drug: HS-20093; Drug: Bevacizumab; Drug: 5-FU; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

HS-20093 DRUG

administered as an IV infusion

Arm 2; Arm 3; Arm 4; Arm 5; Arm1

Bevacizumab DRUG

administered as an IV infusion

Arm 2; Arm 3; Arm 4; Arm 5; Arm1

5-FU DRUG

administered as an IV infusion

Arm 2; Arm 3; Arm 5

Leucovorin DRUG

administered as an IV infusion

Arm 2; Arm 5

Capecitabine DRUG

administered orally

Arm 4

Oxaliplatin DRUG

administered as an IV infusion

Arm 5

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 colorectal cancer.
• Dose escalation part will enroll advanced metastatic colorectal cancer patients who have progressed on or intolerant to standard therapies.
• Dose expansion part will enroll advanced metastatic colorectal cancer patients who have not received prior treatment for advanced/metastatic colorectal cancer.
• At least one measurable lesion according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
• Life expectancy \>= 12 weeks.
• 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:

• Treatment with any of the following:
• Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors as the payload
• 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.
• Inadequate bone marrow reserve or organ dysfunction
• Evidence of cardiovascular risk.
• Severe, uncontrolled or active cardiovascular diseases.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Fluorouracil; Leucovorin; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Central Study Contacts

Ying Yuan

CONTACT

Yuanying1999@zju.org.cn

Study Design

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

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: October 3, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (1)