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A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Evidence of a personally signed and dated ICF indicating that the subject has been informed of all pertinent aspects of the study.

Age > 18.

ECOG performance status of 0-1.

Life expectancy of ≥ 3 months.

Disqualifiers

Plan to receive any other anti-tumor treatments during the treatment period of this study.

Subjects participated in a prior investigational study or received anticancer treatment, and have not recovered from side effects of such therapy.

Underwent major surgical operation within 4 weeks before the first dose of this IP.

Received treatments with strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers within < 5 half-lives of the drug before the first dose of the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A1904

    Drug

    Single Arm ：It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors

Treatment groups

83 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment.

Time frame
The first cycle of administration, up to 21 days.
2

Maximum tolerated dose (MTD)

MTD is defined as the dose with the estimated toxicity probability which is the closest to the target toxicity probability.

Time frame
The first cycle of administration, up to 21 days.
3

Recommended Phase 2 Dose (RP2D)

RP2D is the dose selected for further study based on the phase I study results.

Time frame
The first cycle of administration, up to 21 days.
4

Adverse events (AEs) and serious adverse events (SAEs)

Time frame
From the signing of informed consent form to the end of safety follow-up period (90 days after the last dose).

Secondary outcomes

1

Objective response rate (ORR)

The proportion of efficacy evaluable subjects with the best overall response (BOR) of CR or PR as per RECIST 1.1 criteria.

Time frame
Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated March 2026.
2

Duration of response (DoR)

DoR is defined as the time from first documented tumor response (CR/PR) until PD/death.

Time frame
Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.
3

Clinical benefit rate (CBR)

CBR is defined as the percentage of subjects who have achieved complete response (CR), partial response (PR) and/or stable disease (SD) lasting over 24 weeks (CR+PR+SD≥24 weeks).

Time frame
Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.
4

Progression-free survival (PFS)

PFS is defined as the time from the first dose until PD/death.

Time frame
Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject.

Other outcomes

Sponsors and contacts

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

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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