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A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies 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 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SHR-9839 for Injection

    Drug

    SHR-9839 for injection.

  • SHR-A1921 for Injection

    Drug

    SHR-A1921 for injection.

  • SHR-A2009 for Injection

    Drug

    SHR-A2009 for injection.

  • Almonertinib Mesilate Tablets

    Drug

    Almonertinib Mesilate Tablets.

  • Pemetrexed Disodium for Injection

    Drug

    Pemetrexed Disodium for Injection.

  • Carboplatin for injection

    Drug

    Carboplatin for injection.

  • Paclitaxel injection

    Drug

    Paclitaxel injection.

  • SHR-1316 Injection

    Drug

    SHR-1316 injection.

  • SHR-9839 for Injection (sc)

    Drug

    SHR-9839 for Injection (sc).

Treatment groups

156 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: SHR-9839 combined with SHR-A2009Experimental treatment 2 interventions
Group B: SHR-9839 combined with SHR-A1921Experimental treatment 2 interventions
Group C: SHR-9839 combined with Pemetrexed + CarboplatinExperimental treatment 3 interventions
Group D: SHR-9839 combined with AlmonertinibExperimental treatment 2 interventions
Group E: SHR-9839(sc) + SHR-1316Experimental treatment 2 interventions
Group F: SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc)Experimental treatment 3 interventions
Group G: SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity (DLT) (phase IB)

Time frame
21 days after the first dose was administered to each subject, up to approximately 24 months.
2

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB)

Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).

Time frame
Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.
3

Objective Response Rate (ORR) (phase II).

Evaluated using RECIST 1.1.

Time frame
The first treatment lasted until disease progression, up to approximately 24 months.

Secondary outcomes

1

Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II)

Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).

Time frame
Begin from sign the ICF until the end of the safety follow-up period, up to approximately 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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