About this trial
This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT036 in Subjects with Advanced Malignant Solid Tumour.
In dose escalation and dose expasion phase, the safety, tolerability of RT036 in patients with advanced malignant solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of RT036.
In clinical expansion phase, the preliminary antitumor activity of RT036 in target solid tumors will be evaluated.
In addition, the pharmacokinetic characteristics, and immunogenicity of RT036 in patients with advanced malignant solid tumors will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 years or older at the time of signing the informed consent form (ICF)
Participants with histologically or cytologically confirmed advanced malignant solid tumors;
Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Participants with an expected survival ≥ 12 weeks;
Disqualifiers
Participants with active central nervous system (CNS) metastases are excluded. However, participants are eligible if they have previously received radiotherapy or surgery, and imaging within 4 weeks prior to the first dose shows stable brain metastases without progression or new neurological symptoms, and corticosteroids have been withheld for at least 2 weeks prior to first dose. Participants with leptomeningeal or brainstem metastasis are not eligible regardless of treatment status;
Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated intervention, or with a history of hypertensive crisis or hypertensive encephalopathy;
Participants with poorly controlled hypertension (defined as repeated measurements of systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite antihypertensive therapy), or with a history of hypertensive crisis or hypertensive encephalopathy;
Participants with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requiring corticosteroid therapy (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, etc.), or participants with current ILD/non-infectious pneumonitis;
Trial design
Sequential
Treatments tested in this trial
RT036 for injection
DrugIntravenous (IV) Infusion
Treatment groups
Trial outcomes
Primary outcomes
DLT
Incidence of dose-limiting toxicities (DLTs)
MTD
To determine the maximum tolerated dose
RP2D
To determine the recommended phase 2 dose
AE
Incidence and severity of adverse events
Secondary outcomes
ORR
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
DCR
Disease control rate (DCR) as assessed by investigator per RECIST v1.1
DoR
Duration of response (DoR) as assessed by investigator per RECIST v1.1
PFS
Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1.
Locations
Sponsors and contacts
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