Solid TumorsPhase 1/2NCT07537881
A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors
A Phase 1/2 study testing RC288 For Injection in people with Solid Tumors, run by RemeGen Co., Ltd. at 14 sites in China.
Trial summary
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; Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- RC288 For Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 14 sitesChina
- Study dates
- 27 Apr 2026to 30 Jun 2030
- 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 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;
- According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
- Sufficient bone marrow, liver, kidney, and blood clotting function
Who cannot join
- 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.
- Subjects with acute, chronic, or symptomatic infections.
- Subjects with uncontrolled cardiovascular diseases.
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- Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
- History of underlying pulmonary disease.
- Subjects with a history of cirrhosis (Child-Pugh B or C class).
- Clinically significant gastrointestinal disease.
- Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
- Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening.
- Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation.
- History of arterial/venous thromboembolic events within 6 months prior to the first dose.
- Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods.
- History of active autoimmune disease requiring systemic therapy within the past 2 years.
- History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy.
- History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- History of or current poorly controlled psychiatric disorder.
- Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures.
- Presence of any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion of a condition that contraindicates the use of the investigational drug, may affect the interpretation of study results, or places the patient at high risk.
- Local or systemic diseases not caused by malignancy, or diseases or symptoms secondary to the tumor, which may lead to higher medical risks and/or uncertainty in survival assessment.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Weiqing Han, +86731-89762271, md70210@sina.com
- Not yet recruiting
Fujian Cancer Hospital
Fujian, Fuzhou
Zhangzhou Huang
- Not yet recruiting
Fujian Medical University Union Hospital
Fujian, Fuzhou
Jinhuo Lai
- Not yet recruiting
Sun Yat sen University Cancer Center
Guangdong, Guangzhou
Yanxia Shi
Yonghong Li
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guizhou, Guiyang
Huixin Ge
- Not yet recruiting
Harbin Medical University Cancer Hospital
Heilongjiang, Haerbin
Baogang Liu
- Not yet recruiting
Hunan Cancer Hospital
Hunan, Changsha
Lin Wu
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
- Not yet recruiting
Cancer Hospital of Shandong First Medical University Cancer Hospital
Shandong, Jinan
Benkui Zou
Juan Li
- Recruiting
Shanxi Cancer Hospital
Shandong, Jinan
- Recruiting
Shanxi Cancer Hospital
Shanxi, Shanxi
- Not yet recruiting
Sichuan Cancer Hospital & Institute
Sichuan, Chengdu
Huangming Hong
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Zhejiang, Taizhou
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Zhejiang, Wenzhou
Wei Chen
About this study
Official title: A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC288 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor.
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;
- Conditions
- Solid Tumors
- Being tested
- RC288 For Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC288 For InjectionDrug
Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
RC288 For InjectionDrug
Intravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
| Study group | Role | What they receive |
|---|---|---|
| RC288 (Phase I, dose escalation) | Experimental | There are six predefined escalating dose levels. Receives: Drug: RC288 For Injection |
| RC288 (Phase II, dose expansion) | Experimental | In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC288 in various cancer types using the RP2D. Receives: Drug: RC288 For Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Measured: 24 months
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0)
Measured: 24 months
Determine RP2D of RC288
Measured: 24 months
MTD and/or MAD
Measured: 24 months
Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria
Measured: 24 months
Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria
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 posted17 Apr 2026
- Study start27 Apr 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- 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
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537881
- Sponsor's protocol ID
- RC288-C101
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 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 RC288 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor.
- ClinicalTrials.gov ID
- NCT07537881
- Acronym / sponsor ID
- RC288-C101
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 17 Apr 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.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC288 (Phase I, dose escalation) | Experimental | Drug: RC288 For InjectionThere are six predefined escalating dose levels. |
| RC288 (Phase II, dose expansion) | Experimental | Drug: RC288 For InjectionIn the multi-indication cohort expansion phase, further assess the efficacy and safety of RC288 in various cancer types using the RP2D. |
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 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;
- According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
Key exclusion criteria (22 listed)
- 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.
- Subjects with acute, chronic, or symptomatic infections.
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 |
|---|---|---|
| RC288 For InjectionIntravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study. | Drug | RC288 (Phase I, dose escalation) |
| RC288 For InjectionIntravenous (IV) administration of RC288. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study. | Drug | RC288 (Phase II, dose expansion) |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: 24 months
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0)
Time frame: 24 months
Determine RP2D of RC288
Time frame: 24 months
MTD and/or MAD
Time frame: 24 months
Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria
Time frame: 24 months
Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria
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 23 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.
14 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 RC288 For Injection in people with Solid Tumors, run by RemeGen Co., Ltd. at 14 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 22 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: looking for participants now, as of the sponsor's last update on 23 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 14 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 (+8610-65384976, 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 (DLT) (time frame: 24 months). The study lists 6 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 23 Sep 2026.