A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements;

The age of signing the informed consent is above 18 years old, regardless of gender; for the SHR-A2102 combined with Disitamab Vedotin cohort, the maximum upper limit was 80 years old

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;

Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors;For the SHR-A2102 combined with Disitamab Vedotin cohort, those who have previously received Disitamab Vedotin treatment or antibody-drug conjugates containing topoisomerase I inhibitors

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

Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy >30 Gy within 6 months prior to initial administration;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A2102

    Drug

    SHR-A2102

  • SHR-A2102 ; Adebrelimab injection

    Drug

    SHR-A2102 + Adebrelimab injection

  • SHR-A2102 + Disitamab Vedotin For Injection

    Drug

    SHR-A2102 + Disitamab Vedotin For Injection

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Treatment group A: SHR-A2102 + Adebrelimab injectionExperimental treatment 1 intervention
Group B: Treatment group B: SHR-A2102Experimental treatment 1 intervention
Group C: Treatment group C: SHR-A2102 + Disitamab Vedotin For InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

RP2D

Time frame
through phase IB completion, an average of 1 years
2

Incidence and severity of AE;

Time frame
from Day1 to 90 days after last dose
3

ORR

Time frame
18 months after the last subject was enrolled in the group

Secondary outcomes

1

DCR(Investigator evaluation)

Time frame
18 months after the last subject was enrolled in the group
2

DoR(Investigator evaluation)

Time frame
18 months after the last subject was enrolled in the group
3

PFS(Investigator evaluation)

Time frame
18 months after the last subject was enrolled in the group
4

OS(Investigator evaluation)

Time frame
18 months after the last subject was enrolled in the group

Other outcomes

Sponsors and contacts

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