NCT07806175

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for phase_1

Timeline
35mo left

Started Sep 2026

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Aug 2029

First Submitted

Initial submission to the registry

August 31, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2029

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

August 31, 2026

Last Update Submit

September 2, 2026

Conditions

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (5)

  • Dose-Limiting Toxicity

    24 months

  • Number of subjects with adverse events (AEs)

    24 months

  • Maximum Tolerated Dose and/or Maximum Administered Dose

    24 months

  • Recommended Phase 2 Dose

    24 months

  • Objective Response Rate (ORR)

    24 months

Secondary Outcomes (6)

  • Objective Response Rate

    24 months

  • Adverse Events/Serious Adverse Event

    24 months

  • Disease Control Rate

    24 months

  • Duration of Response

    24 months

  • Progression-Free Survival

    24 months

  • +1 more secondary outcomes

Study Arms (2)

RCZY690（Phase I,dose escalation）

EXPERIMENTAL

There are seven predefined escalating dose levels

Drug: RCZY690 Tablets

RCZY690（Phase II,Single Drug Dose Optimization Expansion）

EXPERIMENTAL
Drug: RCZY690 tables

Interventions

RCZY690 TabletsDRUG

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（Phase I,dose escalation）
RCZY690 tablesDRUG

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（Phase II,Single Drug Dose Optimization Expansion）

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • At least one measurable target lesion based on imaging assessment per RECIST version 1.1 criteria.
  • Adequate bone marrow, hepatic, renal and coagulation function.

You may not qualify if:

  • 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.
  • Known hypersensitivity or delayed-type allergic reaction to any components of the investigational drug or similar agents.
  • Any condition that impairs the participant's ability to swallow study medication, or conditions judged by the investigator to significantly affect study drug absorption.
  • Participants with acute, chronic or symptomatic infection.
  • Uncontrolled cardiovascular disease.
  • Participants with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonitis or other pulmonary diseases.
  • History of liver cirrhosis (Child-Pugh Class B or C).
  • Active inflammatory bowel disease.
  • Participants with uncontrolled diabetes (HbA1c ≥10%).
  • Arterial or venous thromboembolic events within 6 months prior to the first study drug administration.
  • Pericardial effusion, cardiac tamponade, or third-space effusions (including massive pleural effusion or ascites) that cannot be stably controlled by drainage or other measures as judged by the investigator.
  • Active autoimmune disease requiring systemic therapy within the past 2 years.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cancer Hospital, CAMS

Beijing, Beijing Municipality, China

Location

Hunan Provincial Cancer Hospital

Hunan, Changsha, China

Location

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, China

Location

Shandong Cancer Hospital

Shandong, Jinan, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial Cancer Hospital

Shanxi, Taiyuan, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location

Central Study Contacts

Heping Liu

CONTACT

010-65384976heping.liu@remegen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 8, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

August 15, 2028

Study Completion (Estimated)

August 15, 2029

Last Updated

September 8, 2026

Record last verified: 2026-09

Locations

CN(8)