A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced 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 an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Eligibility criteria

Qualifiers

Aged 18-75 years old (inclusive), regardless of gender.

Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.

At least one measurable tumor lesion according to RECIST v1.1.

ECOG performance score of 0-1.

Disqualifiers

Patients with active central nervous system ( CNS ) metastases.

Spinal cord compression not be cured by surgery or radiotherapy.

Subjects with uncontrollable tumor-related pain.

Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.

Trial design

Treatments tested in this trial

  • SHR-9839 for Injection
  • SHR-A1921 for Injection
  • SHR-A2009 for Injection
  • Almonertinib Mesilate Tablets
  • Pemetrexed Disodium for Injection
  • Carboplatin for injection
  • Paclitaxel injection
  • SHR-1316 Injection
  • SHR-9839 for Injection (sc)

Treatment groups

156 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.