A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC278 at the RP2D dose;

Eligibility criteria

Qualifiers

Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;

Age between 18 and 75 years (including 18 and 75 years);

ECOG PS score of 0 or 1;

Expected survival ≥12 weeks;

Disqualifiers

Pregnant, breastfeeding, or intending to become pregnant subjects.

Subjects with brain metastases.

Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.

Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.

Trial design

Treatments tested in this trial

  • RC278

Treatment groups

312 Participants
are divided into 4 treatment groups

Sponsors and collaborators