A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors

NCT05867303 | Active Not Recruiting Phase 1

• 1 other identifier: RC198-G001
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 5

Brief Summary

Safety study of RC198 in Subjects with Solid Tumors.

Conditions

Melanoma; Urothelial Carcinoma; Renal Cell Carcinoma; Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Colorectal Carcinoma

Keywords

Locally advanced unresectable or metastatic solid tumors

Outcome Measures

Primary Outcomes (3)

• MTD based on number of dose-limiting toxicities (DLTs)

  The maximum tolerated dose (MTD) will be assessed based on the number of patients experiencing DLTs, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

  First 4 weeks (28 days) after first dose of study drug

• Determine Recommended Phase 2 Dose (RP2D)

  The RP2D may be selected based on the MTD following consultation with the safety monitoring committee with all available data.

  Informed consent through 28 days after the last dose of study drug

• Incidence of Adverse Events [Safety and tolerability]

  The adverse events occurring or worsening on or after the first dose of the study drug will be recorded.

  Informed consent through 28 days after the last dose of study drug

Secondary Outcomes (8)

• Time to maximum serum concentration [Tmax]

  Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)

• Area under the serum concentration verus time curve [AUC]

  Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)

• Maximum serum Concentration [Cmax]

  Day 1- Day 5 of Week 1 and Week 4, Day 1 of Week 2, Week 3, Week 5 and Week 6 during cycle 1, and Day 1 of Week 1 and Week 4 during subsequent cycles, and EOT (7 days within subject discontinued study drug)

• Immunogenicity of RC198

  D1 of W1 and W3 during cycle 1, and D1 of W1 during subsequent cycles, and EOT (7 days within subject discontinued study drug)

• Object Response Rate (ORR)

  Screening, then every 6 weeks (±7 days) after Day 1 of Cycle 1 Week 1 until 14 days after the last dose of the study drug. Assessed up to 24 months.

Study Arms (1)

RC198 Injection

EXPERIMENTAL

RC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle.

Drug: RC198 Injection

Interventions

RC198 Injection DRUG

RC198 injection will be administered subcutaneously on Day 1 of Week 1 to Week 4 (inclusive) of each 6-week (42-day) cycle.

RC198 Injection

Eligibility Criteria

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

You may qualify if:

• Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.
• Subjects with locally advanced unresectable or metastatic solid tumors who experience disease progression after standard treatment, or unable to tolerate standard treatment, or refuse standard treatment.
• At least 1 measurable or evaluable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
• Male or female aged ≥ 18 years.
• ECOG PS score of 0 or 1.
• Anticipated life expectancy of \> 12 weeks.
• Adequate bone marrow, liver, and renal function defined as:
• Absolute neutrophil count ≥ 1.5× 109/L.
• Absolute lymphocyte count ≥ 500/μL.
• Platelet ≥ 100 × 109/L.
• Hemoglobin ≥ 90 g/L without receiving erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), or granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days and blood transfusion including red blood cell and platelet transfusion in at least 7 days prior to first dose of investigational product.
• Total bilirubin ≤ 1.5 × ULN or up to 3 × ULN if Gilbert syndrome.
• Alanine aminotransaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 × ULN when there is no liver metastasis. ALT, AST ≤ 5 × ULN when there is liver metastasis
• Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min (using Cockcroft-Gault formula); Urine protein \< 2 + or 24 hour total urine protein quantity \< 1g.
• Activated partial thromboplastin time (APTT) ≤ 1.5× ULN; international normalized ratio (INR) ≤ 1.5.

You may not qualify if:

• Pregnant or lactating.
• Known to be human immunodeficiency virus (HIV) positive, with active hepatitis (HBV) characterized by elevated levels of HBV ribonucleic acid exceeding the ULN; or active hepatitis C (HCV) with positive HCV ribonucleic acid (RNA); Subjects who are Hepatitis B surface antigen positive or hepatitis B core antibody positive must have undetectable quantitative DNA polymerase chain reaction (PCR).
• Administration of a live vaccine within 28 days before first dose of investigational and during the study. Note: Seasonal vaccines for influenza or Coronavirus Disease 2019 (COVID-19) vaccines are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
• Previous anti-tumor therapies (including surgery, chemotherapy, traditional Chinese medicine, radiotherapy, immunotherapy, biological therapy, hormonal therapy, or investigational agents for cancer treatment) within 4 weeks or within 5 half-lives of anti-tumor agents, whichever is shorter, prior to the first dose of investigational product, or palliative radiotherapy for bone metastases within 2 weeks prior to the first dose of investigational product.
• Previous adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to Investigator's opinion) or Baseline within 4 weeks prior to first administration of the investigational product.
• Experienced prior Grade 3 or higher immune-related toxicity that resulted in permanent drug discontinuation (subjects with prior temporary drug interruptions due to endocrinopathies etc. are eligible).
• History of therapy with an agent targeting of IL-15 or IL-2.
• Known hypersensitivity to any excipient contained in the drug formulation of investigational products or supplements to be administered during the study.
• Uncontrolled diseases including:
• Uncontrolled infection requiring systematic antibiotics, antivirals or antifungals within 4 weeks prior to first administration of the investigational product.
• Active infection with COVID-19.
• Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti-tuberculosis therapy within 1 year prior to first administration of the investigational product.
• Symptomatic congestive heart failure Grade II-IV (New York Heart Association \[NYHA\]), symptomatic or uncontrolled arrhythmias, QTc interval \> 480 ms or personal or family history of congenital long/short QT syndrome, Severe or unstable angina pectoris, coronary or peripheral artery bypass grafting.
• Uncontrollable hypertension (systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg).
• Systemic diseases, including diabetes pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (5)

ICON Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

Location

Southern Oncology Clinical Research Unit

Bedford Park, South Australia, 5042, Australia

Location

Cabrini Hospital Malvern

Malvern, Victoria, 3144, Australia

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430061, China

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Transitional Cell; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

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

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 19, 2023
• Study Start: June 5, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

AU (3); CN (2)