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A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 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 RC288; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC288 at the RP2D dose;

Eligibility criteria

This trial does not accept healthy volunteers

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 v6.0 Grade 1.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • RC288 For Injection

    Drug

    Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.

  • RC288 For Injection

    Drug

    Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.

Treatment groups

326 Participants
are divided into 2 treatment groups
Group A: RC288 (Phase I, dose escalation)Experimental treatment 1 intervention
Group B: RC288 (Phase II, dose expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT)

Time frame
24 months
2

Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0)

Time frame
24 months
3

Determine RP2D of RC288

Time frame
24 months
4

MTD and/or MAD

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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