Active — Not RecruitingPhase 1

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

Australia, China48 participantsStarted 2023-06-05

Plain-language summary

Safety study of RC198 in Subjects with Solid Tumors.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Left ventricular ejection fraction ≥ 50%, as determined by echocardiogram or multiple-gated acquisition (MUGA) scan.

Exclusion criteria

✕. 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.

What they're measuring

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

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

Determine Recommended Phase 2 Dose (RP2D)

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

Incidence of Adverse Events [Safety and tolerability]

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

Trial details

NCT IDNCT05867303

SponsorRemeGen Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Melanoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. Left ventricular ejection fraction ≥ 50%, as determined by echocardiogram or multiple-gated acquisition (MUGA) scan.

Exclusion criteria

✕. 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.

What they're measuring

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

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

Determine Recommended Phase 2 Dose (RP2D)

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

Incidence of Adverse Events [Safety and tolerability]

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