Phase I Study of SHR-2022 Injection in the Treatment of Patients With Advanced Malignant Tumors

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up

Age 18-80 years old (including both ends), both male and female

Subjects with advanced or metastatic malignant tumors confirmed by pathological tissue or cytology, and who have failed previous standard treatments, are intolerant to standard treatments, or have no standard treatments

Have measurable lesions

Disqualifiers

Central nervous system metastasis or meningeal metastasis with clinical symptoms

Spinal cord compression that has not been treated radically by surgery and/or radiotherapy

Patients with uncontrolled tumor-related pain as judged by the investigator

A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-2022 Injection

    Drug

    SHR-2022 Injection is administered by intravenous (IV) infusion

Treatment groups

116 Participants
are divided into 1 treatment group
Group A: SHR-2022 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Time frame
up to 3 years
2

Severity of adverse events

Time frame
up to 3 years
3

MTD

Time frame
up to 3 years
4

RP2D

Time frame
up to 3 years

Secondary outcomes

1

Time to maximum concentration (Tmax)

Time frame
up to 3 year
2

Maximum concentration (Cmax)

Time frame
up to 3 year
3

Receptor Occupancy(OR) of SHR-2022

Time frame
up to 3 year
4

Anti-drug antibody (ADA) of SHR-2022

Time frame
up to 3 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: