A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RCZY690 in Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRongchang Pharmaceuticals Co., Ltd.

About this trial

This study aims to evaluate the safety and efficacy of RCZY690 therapy in participants with advanced malignant solid tumors. Participants will receive RCZY690 monotherapy until the end of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in this study, sign the informed consent form, and be able to comply with the study protocol.

Age between 18 and 75 years inclusive.

ECOG performance status of 0 or 1.

Expected survival ≥ 12 weeks.

Disqualifiers

Female participants who are pregnant, lactating, or planning to become pregnant.

Participants with brain metastases.

History of severe bleeding tendency or coagulation dysfunction.

Toxicities from prior anti-tumor therapy have not recovered to Grade 1 per NCI-CTCAE version 6.0.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RCZY690 Tablets

    Drug

    Oral medication. The patient will continue treatment until unacceptable toxic reactions occur, the disease progresses, or any criteria for leaving the study are met.

  • RCZY690 tables

    Drug

    Oral medication. The patient will continue treatment until unacceptable toxic reactions occur, the disease progresses, or any criteria for leaving the study are met.

Treatment groups

486 Participants
are divided into 2 treatment groups
Group A: RCZY690(Phase I,dose escalation)Experimental treatment 1 intervention
Group B: RCZY690(Phase II,Single Drug Dose Optimization Expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity

Time frame
24 months
2

Number of subjects with adverse events (AEs)

Time frame
24 months
3

Maximum Tolerated Dose and/or Maximum Administered Dose

Time frame
24 months
4

Recommended Phase 2 Dose

Time frame
24 months

Secondary outcomes

1

Objective Response Rate

Time frame
24 months
2

Adverse Events/Serious Adverse Event

Time frame
24 months
3

Disease Control Rate

Time frame
24 months
4

Duration of Response

Time frame
24 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: