A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects With Advanced Malignant Solid Tumour

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of JS212 in Subjects with Advanced Malignant Solid Tumour. Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects of either sex who are 18 to 75 years of age (inclusive of 18 and 75 years) at the time of signing the consent form;

Histologically or cytologically confirmed advanced malignant solid tumors;

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;

Expected survival of ≥ 12 weeks;

Disqualifiers

Presence of active central nervous system metastasis. If previous radiotherapy or surgery, etc. has been received, and the imaging examination within 4 weeks before the first dose suggests that the brain metastasis is stable without exacerbation or new neurological symptoms, and hormone therapy has been discontinued two weeks before the first dose, screening is allowed; for the presence of meningeal metastasis and brainstem metastasis, regardless of the treatment or not, screening is not allowed;

Presence of clinically symptomatic pleural effusion, ascites, or pericardial effusion that requires repeated management (puncture or drainage, etc.);

Presence of medically uncontrolled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;

Presence of a history of (non-infectious) interstitial lung disease (ILD)/non-infectious pneumonia requiring steroid therapy (e.g., idiopathic pulmonary fibrosis, mechanized pneumonia, drug-induced pneumonia, radiation pneumonitis, idiopathic pneumonia, etc.), and current ILD/non-infectious pneumonia;

Trial design

Design model

Sequential

Treatments tested in this trial

  • JS212 for Injection

    Drug

    JS212 for Injection is administered on the first day of the first cycle and every 3 weeks thereafter.

Treatment groups

374 Participants
are divided into 1 treatment group
Group A: JS212Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

Incidence and severity of DLT events

Time frame
Up to 1 years
2

Incidence and severity of Adverse Events

Abnormal changes in clinical symptoms, vital signs, physical examination, laboratory tests, electrocardiograph and other examinations.

Time frame
Up to 2 years
3

MTD

Maximum tolerated dose

Time frame
Up to 1 years
4

RP2D

Recommended phase II dose

Time frame
Up to 1 years

Secondary outcomes

1

DOR

Duration of Objective Response (DOR) as Assessed by Investigator according to RECIST v1.1

Time frame
Up to 2 years
2

DCR

Investigator-assessed Duration of objective Response (DCR) according to RECIST v1.1

Time frame
Up to 2 years
3

Progression-Free Survival (PFS)

Progression-Free Survival (PFS) as Determined by Investigator according to RECIST v1.1

Time frame
Up to 2 years
4

Overall Survival (OS)

Overall Survival (OS)

Time frame
Up to 2 years

Other outcomes

1

To explore the correlation between potential MARKERS and efficacy

To explore the correlation between potential MARKERS and efficacy

Time frame
Up to 2 years
2

To explore the correlation between serum β-Glucuronidase Concentrations and efficacy

To explore the correlation between serum β-Glucuronidase Concentrations and efficacy

Time frame
Up to 2 years

Sponsors and contacts

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