A Phase II Study of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 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, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-80 years old;

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment;

Provide archived or fresh tumor tissue;HER2 expression is required for subjects in Stage I;

Disqualifiers

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

Subjects with peripheral neuropathy;

Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment;

Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-4602

    Drug

    SHR-4602

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: SHR-4602Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR by investigator assessment

ORR by investigator assessment was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR), Up to approximately 5 years;

Time frame
Up to approximately 5 years;

Secondary outcomes

1

DCR by investigator assessment,

DCR by investigator assessment was defined as the percentage of participants with confirmed response (CR or PR), or SD, per RECIST v1.1 per investigator, Up to approximately 5 years;

Time frame
Up to approximately 5 years;
2

DoR by investigator assessment,

DoR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first, Up to approximately 5 years;

Time frame
Up to approximately 5 year
3

PFS by investigator assessment,

PFS was defined as the time from date of start of study treatment to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first, Up to approximately 5 years;

Time frame
Up to approximately 5 years;
4

OS

OS is defined as the time from start of study treatment to death from any cause, Up to approximately 5 years;

Time frame
Up to approximately 5 years;

Other outcomes

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: