Health TrialsbyHealthPanel

Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

The study was designed to evaluate the efficacy, safety, and pharmacokinetics of SHR2102 in patients with advanced solid tumors. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of SHR-A2102 in phase II study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent;

Age ≥18 years old, gender unlimited;

The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 ~ 1;

Life expectancy Predicted survival ≥3 months;

Disqualifiers

Plan to receive any other antitumor therapy during this trial;

Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study drug;

Received antitumor therapy such as chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to first administration of the study drug (nitrosourea or mitomycin C within 6 weeks prior to first administration; Oral fluorouracil within 2 weeks prior to initial first administration); Palliative radiotherapy or local therapy within 2 weeks before first administration use of the study drug;

Had major surgery other than diagnosis or biopsy within 4 weeks prior to the study's initial dosing;

Trial design

Design model

Single group

Treatments tested in this trial

  • SHR-A2102

    Drug

    SHR-A2102 was given intravenously. Patients may continue to use SHR-A2102 until disease progression or unacceptable toxicity occurs.

Treatment groups

395 Participants
are divided into 1 treatment group
Group A: SHR-A2102Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events

Adverse events are assessed by CTCAE v5.0

Time frame
24 months
2

Maximum tolerated dose (MTD)

MTD is defined as the maximum dose within the first 3 weeks of multiple dosing that does not exceed the proportion of subjects who develop DLT as specified in the protocol's BOIN design.

Time frame
12 weeks
3

Recommended Phase 2 dose (RP2D)

RP2D will be determined based on the available data for toxicity and PK.

Time frame
24 months
4

Dose Limiting Toxicity (DLT)

Adverse events that occurred during the DLT observation period (the first period of study administration, a total of 21 days) that were determined to be related to the study drug (see protocol for details).

Time frame
3 weeks

Secondary outcomes

1

Peak plasma concentration (Cmax)

Time frame
12 weeks
2

Area under the plasma concentration versus time curve (AUC）

Time frame
12 weeks
3

T1/2 (Half-life)

The time required for the plasma concentration of a drug to be reduced by 50%

Time frame
12 weeks
4

Immunogenicity: Number of subjects with anti-SHR-A2102 antibody (ADA), incidence, occurrence time, duration, etc

Time frame
12 weeks

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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