A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age of signing the informed consent is 18 -70 years, regardless of gender.

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

The ECOG score is 0 or 1.

Expected survival ≥12 weeks.

Disqualifiers

Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.

Spinal cord compression not cured by surgery and/or radiotherapy.

Subjects with uncontrolled tumor-related pain.

Received antitumor therapy within 4 weeks before the start of the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A2102

    Drug

    SHR-A2102 for injection.

  • Bevacizumab Injection

    Drug

    Bevacizumab injection.

  • Adebelimab Injection

    Drug

    Adebelimab injection.

  • Ametinib Mesylate Tablets

    Drug

    Ametinib mesylate tablets.

  • Osimertinib Mesylate Tablets

    Drug

    Osimertinib mesylate tablets.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Treatment GroupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
From day 1 to 90 days after the last dose.
2

Serious adverse events (SAEs)

Time frame
From day 1 to 90 days after the last dose.
3

Objective response rate (ORR)

Time frame
About 2 years.

Secondary outcomes

1

Disease control rate (DCR)

Time frame
About 2 years.
2

Duration of response (DOR)

Time frame
About 2 years.
3

Progression free survival (PFS)

Time frame
About 2 years.
4

Overall survival (OS)

Time frame
About 2 years.

Other outcomes

Sponsors and contacts

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