Health TrialsbyHealthPanel

A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Shengdi Pharmaceutical Co., Ltd

About this trial

This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;

Age range: 18-75 years old, both male and female are welcome;

Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;

Have at least one measurable tumor lesion per RECIST v1.1;

Disqualifiers

Patients with active central nervous system metastases or meningeal metastases;

Systemic antitumor therapy was received 4 weeks before the start of the study;

Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;

Have poorly controlled or severe cardiovascular disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-4610 Injection

    Drug

    SHR-4610 injection

  • SHR-A1811 for injection

    Drug

    SHR-A1811 for injection

Treatment groups

258 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Cohort 1 GroupExperimental treatment 1 intervention
Group B: Cohort 2 GroupExperimental treatment 1 intervention
Group C: Cohort 3 GroupExperimental treatment 1 intervention
Group D: Cohort 4 GroupExperimental treatment 1 intervention
Group E: Cohort 5 GroupExperimental treatment 1 intervention
Group F: Cohort 6 GroupExperimental treatment 1 intervention
Group G: Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in StageExperimental treatment 2 interventions
Group H: Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stageExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The Dose-Limiting Toxicity (DLT)

Time frame
Post-dose at day 1 to the end of treatment visit, about 1 year.
2

The Maximum Tolerated Dose (MTD)

Time frame
Post-dose at day 1 to the end of treatment visit, about 1 year.
3

Recommended dosage for Phase II (RP2D)

Time frame
Post-dose at day 1 to the end of treatment visit, about 1 year.
4

Incidence and severity of adverse events (AEs)

Time frame
Up to 90 days after the last administration.

Secondary outcomes

1

Objective Response Rate (ORR)

Time frame
From the first administration to the end of treatment visit, about 1 year.
2

Duration of relief (DOR)

Time frame
From the first administration to the end of treatment visit, about 1 year.
3

Disease Control Rate (DCR)

Time frame
From the first administration to the end of treatment visit, about 1 year.
4

Time to Response (TTR)

Time frame
From the first administration to the end of treatment visit, about 1 year.

Other outcomes

Sponsors and contacts

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

Shanghai Shengdi Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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