Trial intelligence / Profile preview

MRG002 + Pucotenlimab in HER2-expressed Advanced Solid Tumors

NCT05338957Phase 2

Key facts

Status: Unknown
Start: Aug 2022
Primary completion: Jun 2024
Countries: 1
Sponsor: Hangzhou Miracogen
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules

Drugs: MRG002
Conditions: solid tumor

Overview

Phase 2, open-label trial of MRG002 in solid tumor, sponsored by Hangzhou Miracogen. Primary endpoints: Incidence of Dose Limiting Toxicity at 28 days, Incidence of Adverse Events and 1 more. Status: unknown.

Design

Study design: Non-randomizedOpen-label

Who it enrols

Adult patients with HER2-expressed advanced solid tumors, ECOG 0-1, and adequate organ function. Excludes prior ADC therapy and recent checkpoint inhibitors.

Endpoints

Primary

Incidence of Dose Limiting Toxicity28 days
Incidence of Adverse EventsUp to 90 days after last dose
Recommended Phase II DoseUp to 24 months

Secondary

Objective Response RateUp to 24 months
Duration of ResponseUp to 24 months
Disease Control RateUp to 24 months
Progression-Free SurvivalUp to 24 months
Time to ResponseUp to 24 months
Overall SurvivalUp to 24 months
Pharmacokinetic ParametersUp to 90 days after last dose
Anti-Drug AntibodiesUp to 90 days after last dose

Beyond the preview

Go deeper on NCT05338957.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05338957.