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New treatment option for Solid Tumor
Official title A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
ClinicalTrials.gov ID: NCT06016062
What this study is testing
What is RC148 Monotherapy?
RC148 Monotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as RC148 for injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to participate in the study voluntarily and willing to provide written informed consent.
- male or female ≥18 years (phase Ⅰ), 18 to 75 years old (Including 18 and 75 years, phase Ⅱ).
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Projected life expectancy of at least 12 weeks.
- At least one measurable target lesion based on imaging according to RECIST v1.1 criteria (For patients who have received prior radiotherapy...
You likely can't join if
- Pregnant or lactating.
- Cohort 1 in Phase II, patients with histologically or cytologically confirmed non-small cell lung cancer, other than squamous lung cancer and lung...
- Cohorts 4-7 in Phase II, patients with ocular corneal conditions at screening such as congenital corneal dystrophy, meibomian gland dysfunction...
- people with active hepatitis B or C; human immunodeficiency virus (HIV)-positive people.
- Those who have received a live vaccine within 28 days prior to the first RC148 administration or who plan to receive any live vaccine during the...
- Participant with a history of other acquired/congenital immunodeficiency diseases or organ transplantation.
See the full eligibility criteria
Who can join
- Be able to participate in the study voluntarily and willing to provide written informed consent.
- male or female ≥18 years (phase Ⅰ), 18 to 75 years old (Including 18 and 75 years, phase Ⅱ).
- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Projected life expectancy of at least 12 weeks.
- At least one measurable target lesion based on imaging according to RECIST v1.1 criteria (For patients who have received prior radiotherapy, radiotherapy-treated lesions may be considered as target lesions if the lesion...
- Requirements for inclusion of people at different stages: Phase I (RC148 monotherapy): Patients with locally advanced unresectable or metastatic malignant solid tumors whose disease has progressed with standard therapy...
- Participants agree to provide pre-treatment archived/biopsied tumor samples for biomarker-related testing such as retrospective programmed cell death protein 1 (PD-L1) expression levels. Biopsies will be considered at...
- Adequate bone marrow, liver, and renal function defined as: No platelet or red blood cell transfusion within 14 days prior to performing routine blood tests, no correction with thrombopoietin (TPO), erythropoietin...
- For people in Cohort 1 (Non-Small Cell Lung Cancer) and Cohort 4 (Lung Adenocarcinoma) of the Phase II Combined Protocol, pulse oximetry (O2 saturation) measured under unoxygenated conditions was required to be \>92%.
- Cardiac function: left ventricular ejection fraction ≥50%.
- Male or female people with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication, such as double-barrier contraceptive methods...
What rules you out
- Pregnant or lactating.
- Cohort 1 in Phase II, patients with histologically or cytologically confirmed non-small cell lung cancer, other than squamous lung cancer and lung adenocarcinoma, (including people with squamous or adenocarcinoma in...
- Cohorts 4-7 in Phase II, patients with ocular corneal conditions at screening such as congenital corneal dystrophy, meibomian gland dysfunction (MGD), viral keratitis (dendritic, map-like, corneal stromal keratitis)...
- people with active hepatitis B or C; human immunodeficiency virus (HIV)-positive people.
- Those who have received a live vaccine within 28 days prior to the first RC148 administration or who plan to receive any live vaccine during the study period.
- Participant with a history of other acquired/congenital immunodeficiency diseases or organ transplantation.
- Active autoimmune disease requiring systemic therapy, such as systemic lupus erythematosus, psoriasis requiring systemic therapy, or rheumatoid arthritis, within the past 2 years; however, alternative therapies are not...
- Subject has received an immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4 antibody) or other immune checkpoint inhibitor therapy within 28 days prior to initiation of treatment with the study drug or has experienced...
- people who have participated in a clinical trial of another drug and received the test drug within 4 weeks prior to the first dose of RC148.
- Prior concomitant treatment with antitumor agents targeting VEGF/VEGFR and PD-1/PD-L1 (except for people with cervical cancer). For cohorts 2-3 in Part 2, people with prior antibody-drug conjugates treatment. For...
- Known hypersensitivity or delayed hypersensitivity to certain components of the study drug or to similar drugs.
- Participant who are under the treatment of anticoagulant drugs. Participants using prophylactic doses of heparin are eligible in the study.
- Subject received last systemic antitumor therapy, including surgery, chemotherapy, radiotherapy, and biologic therapy within 4 weeks prior to the first study drug administration; received small molecule tyrosine kinase...
- Previous adverse reactions resulting from previous anti-tumour therapies, which have not returned to Grade 1 according to NCI-CTCAE v5.0 at screening.
- Presence of grade ≥2 sensory or motor neuropathy.
- Presence of third interstitial fluid with clinical symptoms or requiring intervention.
- Active infection of clinical significance judged by the investigator.
- Active gastrointestinal bleeding, history of hemoptysis, peptic ulcer, or a hemorrhagic event with NCI CTCAE (V5.0) ≥ grade 2 within 4 weeks prior to screening; or the presence of severe esophagogastric varices...
- Presence of systemic diseases that, in the judgment of the investigator, are not under stable control, including diabetes mellitus, hypertension, cirrhosis of the liver, etc.
- Those with previous and current clinical manifestations or high risk factors for interstitial lung disease (ILD), drug-associated pneumonia, radiation pneumonitis, severely impaired lung function, or suspected...
- Clinically relevant pyelonephrosis that cannot be reduced by ureteral stenting or percutaneous drainage.
- History of gastrointestinal perforation and/or fistula, gastrointestinal obstruction, inflammatory bowel disease, or bowel resection within the past 6 months.
- Screening QTc interval \>450 ms (males), QTc interval \>470 ms (females); previous family or personal history of long/short QT interval syndrome; history of ventricular arrhythmia considered clinically significant by...
- Experienced an arterial/venous thromboembolic event such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, cerebral infarction, or experienced a history of hypertensive crisis or hypertensive...
- History of myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass graft or vascular disease, New York Heart Association (NYHA) grade ≥3 heart failure within 6 months prior to...
- people on systemic therapy with corticosteroids (daily prednisone ≥10 mg/day or equivalent dose of drug) or other immunosuppressive medications within 2 weeks of first study administration.
- people with the presence of brain metastases who have been previously treated for brain metastases may be considered for enrollment (exclusion of brain metastases from gastric cancer): provided that the disease is...
- Major surgery or intervention with incomplete recovery (except tumor biopsy or puncture) within 4 weeks prior to the first dose of study drug; or gross needle aspiration biopsy or other minor surgery, excluding...
- Screening imaging showing tumor invasion of large blood vessels or imaging evidence of tumor invasion of vital organs or risk of developing a fistula; or imaging evidence of tumor encircling a large blood vessel or...
- Other malignancies were present within 5 years before the initiation of study administration, except for malignancies that would be expected to be cured with treatment.
- Previous or current uncontrollable mental illness.
- people with poor compliance who were not expected to cooperate in completing trial procedures.
- Any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the Investigator, gives reason to suspect that the subject has a disease or condition...
The study team makes the final eligibility decision.
Where it's taking place
- Anhui, China
- Beijing, China
- Changchun, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Guilin, China
- Hangzhou, China
- Harbin, China
- Jinan, China
- Meizhou, China
- Nanning, China
- Nanyang, China
- Shanghai, China
- Shenyang, China
- Taiyuan, China
- Wuhan, China
- Yunnan, China
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anhui, China; Beijing, China; Changchun, China; Changsha, China; Chengdu, China; Chongqing, China and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.