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Phase I/II Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors

ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years old, gender not limited;

Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.

Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;

Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.

Disqualifiers

Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;

Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;

Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;

Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-8203 Injection

    Drug

    SHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: SHR-8203 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The number of subjects with dose-limiting toxicity (DLT)

Time frame
From first dose of study treatment until the end of Cycle 1（up to 21 days）
2

Incidence and severity of AEs

Time frame
From the first visit to the end of the safety follow-up period (1 year)
3

Maximum Tolerated Dose

Time frame
During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）
4

Determination of Recommended Phase II dose (RP2D)

Time frame
After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).

Secondary outcomes

1

Duration of Response (DoR)

Time frame
From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
2

Disease Control Rate (DCR)

Time frame
From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
3

Progression free Survival (PFS)

Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.

Time frame
From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
4

Overall Survival (OS)

The time until death due to any cause.

Time frame
From time of first dose of objective disease progression until the date of death (2 years)

Other outcomes

Sponsors and contacts

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

Beijing Suncadia Pharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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