Health TrialsbyHealthPanel

SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor

ConditionCLDN18.2-positive Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study consists of two research phases:

Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.

Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years old (including boundary values);

Volunteer to participate in this clinical study and sign informed consent;

ECOG score 0-1;

Expected survival ≥3 months;

Disqualifiers

Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.

HER2 expression in tumor tissue is positive.

The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.

Has ≥ grade 2 peripheral sensory neuropathy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1904; Adebrelimab

    Drug

    SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab

  • SHR-A1904; CAPOX; Adebrelimab

    Drug

    SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin)

Treatment groups

924 Participants
are divided into 2 treatment groups
Group A: SHR-A1904 combined with AdebrelimabExperimental treatment 1 intervention
Group B: SHR-A1904 combined with CAPOX and AdebrelimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of AE

Phase 1b

Time frame
Up to follow-up period, approximately 24 months
2

Dose Limiting Toxicity (DLT)

Phase 1b

Time frame
approximately 24 months
3

Maximal Tolerable Dose (MTD)

Phase 1b

Time frame
approximately 24 months
4

Phase III Recommended Dose (RP3D)

Phase 1b

Time frame
approximately 24 months

Secondary outcomes

1

SHR-A1904 toxin binding antibody

Phase 1b

Time frame
approximately 24 months
2

SHR-A1904 Total antibody

Phase 1b

Time frame
approximately 24 months
3

Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb)

Phase 1b

Time frame
approximately 24 months
4

Expression level of CLDN18.2 in tumor tissues

Phase 1b

Time frame
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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