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Advanced Malignant Solid TumoursPhase 1/2NCT07844447

A Study of RT036 in Patients With Advanced Solid Tumors

A Phase 1/2 study testing RT036 for injection in people with Advanced Malignant Solid Tumours, run by Shanghai Ruotuo Biosciences Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT036 in Subjects with Advanced Malignant Solid Tumour. In dose escalation and dose expasion phase, the safety, tolerability of RT036 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?
RT036 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 30 Oct 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, or with a history of hypertensive crisis or hypertensive encephalopathy;
  • Participants with poorly controlled hypertension (defined as repeated measurements of systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite antihypertensive therapy), 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 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RT036 in Participants With Advanced Malignant Solid Tumors

This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT036 in Subjects with Advanced Malignant Solid Tumour.

In dose escalation and dose expasion phase, the safety, tolerability of RT036 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 RT036.

Read more

In clinical expansion phase, the preliminary antitumor activity of RT036 in target solid tumors will be evaluated.

In addition, the pharmacokinetic characteristics, and immunogenicity of RT036 in patients with advanced malignant solid tumors will be evaluated.

Being tested
RT036 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RT036 for injectionDrug

    Intravenous (IV) Infusion

Study groups in NCT07844447
Study groupRoleWhat they receive
RT036ExperimentalParticipants with advanced solid tumors will receive pre-defined doses of RT036
Receives: Drug: RT036 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Incidence of dose-limiting toxicities (DLTs)

    Measured: Up to 12 months

  2. MTD

    To determine the maximum tolerated dose

    Measured: Up to 12 months

  3. RP2D

    To determine the recommended phase 2 dose

    Measured: Up to 12 months

  4. AE

    Incidence and severity of adverse events

    Measured: Up to 36 months

Secondary outcomes (5)
  1. ORR

    Objective response rate (ORR) as assessed by the investigator per RECIST v1.1

    Measured: Up to 36 months

  2. DCR

    Disease control rate (DCR) as assessed by investigator per RECIST v1.1

    Measured: Up to 36 months

  3. DoR

    Duration of response (DoR) as assessed by investigator per RECIST v1.1

    Measured: Up to 36 months

  4. PFS

    Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1.

    Measured: Up to 36 months

  5. OS

    Overall survival (OS)

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Oct 2029 (estimated)
  4. Study completion30 Oct 2029 (estimated)

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07844447
Sponsor's protocol ID
RT036-001-I/II
Status last verified
Sep 2026
First submitted
21 Sep 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RT036 for injection 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 28 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 Lin Shen (010-88196561, doctorshenlin@sina.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 4 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 28 Sep 2026.

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