Advanced Malignant Solid TumorsPhase 1/2NCT07806175
A Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RCZY690 in Advanced Solid Tumors
A Phase 1/2 study testing RCZY690 Tablets and RCZY690 tables in people with Advanced Malignant Solid Tumors, run by Rongchang Pharmaceuticals Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumors
- What is being tested?
- RCZY690 Tablets and RCZY690 tables
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- 8 sitesChina
- Study dates
- 15 Sep 2026to 15 Aug 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of other invasive malignancies within 5 years prior to first dose, or any evidence of residual disease from previously diagnosed malignancy.
- History of acquired or congenital immunodeficiency disorders, or history of organ transplantation.
- Past or current poorly controlled psychiatric disorders.
- Poor compliance, and participants who are expected to be unable to comply with study procedures.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Cancer Hospital, CAMS
Beijing, Beijing Municipality
Hunan Provincial Cancer Hospital
Hunan, Changsha
Shandong Cancer Hospital
Shandong, Jinan
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Shanxi Provincial Cancer Hospital
Shanxi, Taiyuan
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
Zhejiang Cancer Hospital
Zhejiang, Hangzhou
About this study
Official title: A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RCZY690 Tablets in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
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.
- Conditions
- Advanced Malignant Solid Tumors
- Being tested
- RCZY690 Tablets, RCZY690 tables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| RCZY690（Phase I,dose escalation） | Experimental | There are seven predefined escalating dose levels Receives: Drug: RCZY690 Tablets |
| RCZY690（Phase II,Single Drug Dose Optimization Expansion） | Experimental | Not described Receives: Drug: RCZY690 tables |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity
Measured: 24 months
Number of subjects with adverse events (AEs)
Measured: 24 months
Maximum Tolerated Dose and/or Maximum Administered Dose
Measured: 24 months
Recommended Phase 2 Dose
Measured: 24 months
Objective Response Rate (ORR)
Measured: 24 months
Secondary outcomes (6)
Objective Response Rate
Measured: 24 months
Adverse Events/Serious Adverse Event
Measured: 24 months
Disease Control Rate
Measured: 24 months
Duration of Response
Measured: 24 months
Progression-Free Survival
Measured: 24 months
Overall Survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rongchang Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806175
- Sponsor's protocol ID
- RCZY690-C101
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RCZY690 Tablets in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07806175
- Acronym / sponsor ID
- RCZY690-C101
- Conditions
- Advanced Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Rongchang Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCZY690（Phase I,dose escalation） | Experimental | Drug: RCZY690 TabletsThere are seven predefined escalating dose levels |
| RCZY690（Phase II,Single Drug Dose Optimization Expansion） | Experimental | Drug: RCZY690 tables |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RCZY690 TabletsOral medication. The patient will continue treatment until unacceptable toxic reactions occur, the disease progresses, or any criteria for leaving the study are met. | Drug | RCZY690（Phase I,dose escalation） |
| RCZY690 tablesOral medication. The patient will continue treatment until unacceptable toxic reactions occur, the disease progresses, or any criteria for leaving the study are met. | Drug | RCZY690（Phase II,Single Drug Dose Optimization Expansion） |
Primary outcome
Dose-Limiting Toxicity
Time frame: 24 months
Number of subjects with adverse events (AEs)
Time frame: 24 months
Maximum Tolerated Dose and/or Maximum Administered Dose
Time frame: 24 months
Recommended Phase 2 Dose
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 24 months
6 secondary outcomes
Objective Response Rate
Time frame: 24 months
Adverse Events/Serious Adverse Event
Time frame: 24 months
Disease Control Rate
Time frame: 24 months
Duration of Response
Time frame: 24 months
Progression-Free Survival
Time frame: 24 months
Overall Survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RCZY690 Tablets and RCZY690 tables in people with Advanced Malignant Solid Tumors, run by Rongchang Pharmaceuticals Co., Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heping Liu (010-65384976, heping.liu@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.