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Phase Ib/II Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study is a multicenter, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.

Age 18~75 years old.

Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.

Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings.

Disqualifiers

Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.

Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.

Presence of any active, known autoimmune disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS2398

    Drug

    HRS2398: Tablets, 40mg/tablet, oral

  • Adebrelimab

    Drug

    Adebrelimab (SHR-1316): injection, 600mg(12mL), intravenous infusion

Treatment groups

88 Participants
are divided into 1 treatment group
Group A: HRS2398 given in combination with adebrelimabExperimental treatment 2 interventions

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 28 days）
2

Determination of Recommended Phase II dose (RP2D)

Time frame
From first dose of study treatment until the end of Cycle 1（up to 28 days）
3

Objective Response Rate (ORR)

Time frame
From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)

Secondary outcomes

1

Disease Control Rate (DCR)

Time frame
From time of first dose of HRS2398 or Adebrelimab until the date of objective disease progression or death (up to 6 months)
2

Duration of Response (DoR)

Time frame
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
3

Progression free Survival (PFS)

Time frame
From time of first dose of objective disease progression until the date of objective disease progression or death (up to 6 months)
4

Overall Survival (OS)

Time frame
From time of first dose of objective disease progression until the date of death (up to 24 months)

Other outcomes

Sponsors and contacts

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

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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