Advanced Malignant Solid TumoursPhase 1/2NCT07797426
A Study of RT023 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing RT023 in people with Advanced Malignant Solid Tumours, run by Shanghai Ruotuo Biosciences Co., Ltd..
Trial summary
This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT023 in Subjects with Advanced Malignant Solid Tumour. In dose escalation and dose expasion phase, the safety, tolerability of RT023 in patients with advanced malignant solid tumors will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumours
- What is being tested?
- RT023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2026to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 years or older at the time of signing the informed consent form (ICF);
- Participants with histologically or cytologically confirmed advanced malignant solid tumors;
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Participants with an expected survival ≥ 12 weeks;
- Participants must have at least one measurable lesion based on RECIST v1.1; In dose escalation phase, participants without measurable lesions are permitted.
Who cannot join
- Participants with active central nervous system (CNS) metastases are excluded. However, participants are eligible if they have previously received radiotherapy or surgery, and imaging within 4 weeks prior to the first dose shows stable brain metastases without progression or new neurological symptoms, and corticosteroids have been withheld for at least 2 weeks prior to first dose. Participants with leptomeningeal or brainstem metastasis are not eligible regardless of treatment status;
- Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated intervention;
- Participants with poorly controlled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;
- Participants with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requiring corticosteroid therapy (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, etc.), or participants with current ILD/non-infectious pneumonitis;
- Participants with clinically significant intercurrent lung-specific illnesses, including but not limited to any underlying pulmonary diseases diagnosed within 3 months prior to the first dose (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, etc.), any autoimmune, connective tissue, inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;
- Participants with a history of immunodeficiency, including a positive test for human immunodeficiency virus (HIV), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Participants with any other conditions that may lead to premature discontinuation from the study, such as severe physical or psychiatric illness or laboratory abnormalities, which may increase the risk of study participation, affect treatment compliance, or interfere with the interpretation of study results, and who are deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RT023 in Patients With Advanced Solid Tumors
This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT023 in Subjects with Advanced Malignant Solid Tumour.
In dose escalation and dose expasion phase, the safety, tolerability of RT023 in patients with advanced malignant solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of RT023.
Read more
In clinical expansion phase, the preliminary antitumor activity of RT023 in target solid tumors will be evaluated.
In addition, the pharmacokinetic characteristics, and immunogenicity of RT023 in patients with advanced malignant solid tumors will be evaluated.
- Conditions
- Advanced Malignant Solid Tumours
- Being tested
- RT023
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT023Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| dose escalation | Experimental | Participants with advanced solid tumors will receive escalating doses of RT023. Receives: Drug: RT023 |
| dose expansion | Experimental | Participants with advanced solid tumors will receive RT023 at doses which are expected to be efficacious and have completed dose escalation. Receives: Drug: RT023 |
| clinical expansion | Experimental | Participants with target tumors will receive RT023 at the Recommended Phase 2 dose (RP2D). Receives: Drug: RT023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Incidence of dose-limiting toxicities (DLTs)
Measured: Up to 12 months
Adverse Events
Incidence and severity of adverse events AEs
Measured: Up to 36 months
MTD
Maximum tolerated dose
Measured: Up to 12 months
RP2D
Recommended phase 2 dose
Measured: Up to 12 months
ORR
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1.
Measured: Up to 36 months
SAEs
incidence and severity of serious adverse events (SAEs)
Measured: Up to 36 months
Secondary outcomes (8)
DoR
Duration of response (DoR) as assessed by investigator per RECIST v1.1
Measured: Up to 36 months
DCR
Disease control rate (DCR) as assessed by investigator per RECIST v1.1
Measured: Up to 36 months
PFS
Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1.
Measured: Up to 36 months
OS
Overall survival (OS)
Measured: Up to 36 months
Cmax
maximum observed concentration (Cmax)
Measured: About 6 months after first dosing
Immunogenicity
Anti-drug antibodies (ADA) and titers
Measured: About 6 months after first dosing
AUC0-t
area under the concentration time curve
Measured: about 6 months after first dosing
t1/2
terminal half life (t1/2)
Measured: about 6 months after first dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start12 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 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 TumoursStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ruotuo Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797426
- Sponsor's protocol ID
- RT023-001-I/II
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RT023 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07797426
- Acronym / sponsor ID
- RT023-001-I/II
- Conditions
- Advanced Malignant Solid Tumours
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Shanghai Ruotuo Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 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 is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT023 in Subjects with Advanced Malignant Solid Tumour.
In dose escalation and dose expasion phase, the safety, tolerability of RT023 in patients with advanced malignant solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of RT023.
In clinical expansion phase, the preliminary antitumor activity of RT023 in target solid tumors will be evaluated.
In addition, the pharmacokinetic characteristics, and immunogenicity of RT023 in patients with advanced malignant solid tumors will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dose escalation | Experimental | Drug: RT023Participants with advanced solid tumors will receive escalating doses of RT023. |
| dose expansion | Experimental | Drug: RT023Participants with advanced solid tumors will receive RT023 at doses which are expected to be efficacious and have completed dose escalation. |
| clinical expansion | Experimental | Drug: RT023Participants with target tumors will receive RT023 at the Recommended Phase 2 dose (RP2D). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged 18 years or older at the time of signing the informed consent form (ICF);
- Participants with histologically or cytologically confirmed advanced malignant solid tumors;
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Participants with an expected survival ≥ 12 weeks;
- Participants must have at least one measurable lesion based on RECIST v1.1; In dose escalation phase, participants without measurable lesions are permitted.
Key exclusion criteria (7 listed)
- Participants with active central nervous system (CNS) metastases are excluded. However, participants are eligible if they have previously received radiotherapy or surgery, and imaging within 4 weeks prior to the first dose shows stable brain metastases without progression or new neurological symptoms, and corticosteroids have been withheld for at least 2 weeks prior to first dose. Participants with leptomeningeal or brainstem metastasis are not eligible regardless of treatment status;
- Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring repeated intervention;
- Participants with poorly controlled hypertension, or with a history of hypertensive crisis or hypertensive encephalopathy;
- Participants with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requiring corticosteroid therapy (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis, idiopathic pneumonitis, etc.), or participants with current ILD/non-infectious pneumonitis;
- Participants with clinically significant intercurrent lung-specific illnesses, including but not limited to any underlying pulmonary diseases diagnosed within 3 months prior to the first dose (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, etc.), any autoimmune, connective tissue, inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;
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 |
|---|---|---|
| RT023Intravenous (IV) Infusion | Drug | clinical expansion, dose escalation, dose expansion |
Primary outcome
DLT
Time frame: Up to 12 months
Incidence of dose-limiting toxicities (DLTs)
Adverse Events
Time frame: Up to 36 months
Incidence and severity of adverse events AEs
MTD
Time frame: Up to 12 months
Maximum tolerated dose
RP2D
Time frame: Up to 12 months
Recommended phase 2 dose
ORR
Time frame: Up to 36 months
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1.
SAEs
Time frame: Up to 36 months
incidence and severity of serious adverse events (SAEs)
8 secondary outcomes
DoR
Time frame: Up to 36 months
DCR
Time frame: Up to 36 months
PFS
Time frame: Up to 36 months
OS
Time frame: Up to 36 months
Cmax
Time frame: About 6 months after first dosing
Immunogenicity
Time frame: About 6 months after first dosing
AUC0-t
Time frame: about 6 months after first dosing
t1/2
Time frame: about 6 months after first dosing
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 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RT023 in people with Advanced Malignant Solid Tumours, run by Shanghai Ruotuo Biosciences Co., Ltd..
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 5 inclusion and 7 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 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Caicun Zhou (+8613301825532, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Up to 12 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 1 Sep 2026.