A Study of RT023 in Patients With Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Ruotuo Biosciences Co., Ltd.

About this trial

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT023 in Subjects with Advanced Malignant Solid Tumour.

In dose escalation and dose expasion phase, the safety, tolerability of RT023 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 RT023.

In clinical expansion phase, the preliminary antitumor activity of RT023 in target solid tumors will be evaluated.

In addition, the pharmacokinetic characteristics, and immunogenicity of RT023 in patients with advanced malignant solid tumors will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Participants with poorly controlled hypertension, 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

Design model

Sequential

Treatments tested in this trial

  • RT023

    Drug

    Intravenous (IV) Infusion

Treatment groups

318 Participants
are divided into 3 treatment groups
Group A: dose escalationExperimental treatment 1 intervention
Group B: dose expansionExperimental treatment 1 intervention
Group C: clinical expansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

Incidence of dose-limiting toxicities (DLTs)

Time frame
Up to 12 months
2

Adverse Events

Incidence and severity of adverse events AEs

Time frame
Up to 36 months
3

MTD

Maximum tolerated dose

Time frame
Up to 12 months
4

RP2D

Recommended phase 2 dose

Time frame
Up to 12 months

Secondary outcomes

1

DoR

Duration of response (DoR) as assessed by investigator per RECIST v1.1

Time frame
Up to 36 months
2

DCR

Disease control rate (DCR) as assessed by investigator per RECIST v1.1

Time frame
Up to 36 months
3

PFS

Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1.

Time frame
Up to 36 months
4

OS

Overall survival (OS)

Time frame
Up to 36 months

Other outcomes

1

Biomarkers in tumor tissue

To explore the correlation between biomarkers and the efficacy.

Time frame
Up to 36 months

Locations

This trial has no locations.

Sponsors and contacts

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