Solid Tumor CancerNCT07046780
A Multicenter, Prospective, Non-Interventional Real-World Study of Iparomlimab and Tuvonralimab Injection (QL1706) in the Treatment of Locally Advanced or Metastatic Solid Tumors
An observational study of Solid Tumor Cancer and Metastatic Solid Tumors, run by PENG YUAN at 1 site in China.
Trial summary
This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Metastatic Solid Tumors, Locally Advanced
- What is being tested?
- Observation arm
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
Study population: Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy.
Who may be able to join
- 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;
- 2) ECOG performance status 0-2;
- 3) ≥1 measurable lesion per RECIST v1.1 ;
- 4) Adequate organ function meeting ALL criteria below:
- Hematology (without transfusion/G-CSF support within 7 days):
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets ≥100×10⁹/L Hemoglobin ≥90 g/L
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- Biochemistry :
- Total bilirubin (TBIL) ≤2×ULN ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present) Serum creatinine (Cr) ≤1.5×ULN Albumin ≥28 g/L
- Urinalysis :
- Urine protein <2+ (dipstick) If protein ≥2+, 24h urinary protein ≤1.0 g
- Coagulation (without anticoagulants):
- PT/APTT/INR ≤1.5×ULN
- 5) Life expectancy ≥12 weeks;
- 6) Contraception : Females of childbearing potential or males with partners of childbearing potential must use effective contraception during treatment and for 6 months post-treatment;
- 7) Signed informed consent and protocol compliance.
Who cannot join
- 1) Tumor-Related Conditions
- Known CNS metastases (except those radiologically stable ≥4 weeks after radiotherapy);
- Other malignancies within past 5 years, excluding:
- Cured basal/squamous cell skin cancer Localized low-risk prostate cancer Cervical/breast carcinoma in situ
- Severe bone lesions from metastatic disease, including:
- Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;
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- Uncontrolled effusions requiring recurrent drainage (pleural/pericardial/ascites), per investigator assessment.
- 2) Prior Anti-tumor Therapy
- Prior systemic therapy with CTLA-4 inhibitors or other ICIs;
- Any anti-tumor treatment within 4 weeks before first dose, including:
- Surgery/chemotherapy/palliative radiotherapy to non-target lesions/hormonal/targeted/biologic/immunotherapy;
- Treatment-related toxicities not recovered to CTCAE grade ≤1 (exceptions: alopecia/platinum-induced neuropathy ≤ grade 2).
- 3) Comorbidities \& History
- Arterial thromboembolism within 6 months (MI/unstable angina/stroke/TIA);
- Symptomatic heart failure (NYHA class III-IV), unstable angina, or uncontrolled arrhythmia;
- Severe pulmonary disease : ILD/COPD/symptomatic bronchospasm;
- Active uncontrolled infection (≥CTCAE grade 2), including:
- HIV Active HBV (DNA ≥500 IU/mL) HCV (Ab+ with detectable RNA) HBV/HCV co-infection;
- History of neurologic/psychiatric disorders;
- Recent or current substance abuse;
- Prior allogeneic organ/hematopoietic stem cell transplantation.
- 4) Hypersensitivity to study drug or its excipients.
- 5) Active autoimmune disease requiring treatment or history within 2 years. Exceptions: Vitiligo/alopecia/psoriasis not needing systemic therapy Hypothyroidism managed only with hormone replacement Type 1 diabetes controlled solely with insulin.
- 6) Pregnant/lactating women;
- 7) Any uncontrolled systemic disease increasing study risk (per investigator);
- 8) Other unsuitable conditions determined by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Xue Wang, 86-010-8778724, wxyxyuki@163.com
About this study
This study is a prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.
- Being tested
- Observation arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation armDrug
To observe the efficacy and safety of Iparomilimab and Tuvonralimab in the treatment of patients with solid tumors in the real world
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Patients treated with Iparomilimab and Tuvonralimab in the real world Receives: Drug: Observation arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥3 irAEs
Measured: 2 years
Secondary outcomes (3)
Incidence of adverse events
Measured: 2 years
Incidence of treatment-related adverse events
Measured: 2 years
Incidence of immune-related adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- PENG YUAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046780
- Sponsor's protocol ID
- NCC5416
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-Interventional Real-World Study of Iparomlimab and Tuvonralimab Injection (QL1706) in the Treatment of Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07046780
- Acronym / sponsor ID
- NCC5416
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- PENG YUANUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Jul 2025 (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 prospective, observational, real-world, multi-center study planning to enroll 90 patients. The study will observe and document patients' actual clinical practices in receiving Iparomlimab and Tuvonralimab Injection (QL1706). The primary objectives are to evaluate the safety and effectiveness of Iparomlimab and Tuvonralimab Injection (QL1706) in treating locally advanced or metastatic solid tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Drug: Observation armPatients treated with Iparomilimab and Tuvonralimab in the real world |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy.
Key inclusion criteria (15 listed)
- 1) Histologically or cytologically confirmed locally advanced or metastatic solid tumors with disease progression (radiographic or clinical) after ≥1 line of prior standard therapy, unsuitable for/intolerant to standard therapy. Includes but not limited to: Gastrointestinal tumors (colorectal cancer, hepatocellular carcinoma, esophageal cancer, biliary tract cancer, pancreatic cancer, gastric cancer), Breast cancer, Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Soft tissue sarcoma;
- 2) ECOG performance status 0-2;
- 3) ≥1 measurable lesion per RECIST v1.1 ;
- 4) Adequate organ function meeting ALL criteria below:
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelets ≥100×10⁹/L Hemoglobin ≥90 g/L
Key exclusion criteria (26 listed)
- 1) Tumor-Related Conditions
- Cured basal/squamous cell skin cancer Localized low-risk prostate cancer Cervical/breast carcinoma in situ
- Uncontrolled bone pain Pathologic fractures at critical sites (within 6 months) or impending spinal cord compression;
- 2) Prior Anti-tumor Therapy
- Surgery/chemotherapy/palliative radiotherapy to non-target lesions/hormonal/targeted/biologic/immunotherapy;
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 |
|---|---|---|
| Observation armTo observe the efficacy and safety of Iparomilimab and Tuvonralimab in the treatment of patients with solid tumors in the real world | Drug | Observation group |
Primary outcome
Incidence of Grade ≥3 irAEs
Time frame: 2 years
3 secondary outcomes
Incidence of adverse events
Time frame: 2 years
Incidence of treatment-related adverse events
Time frame: 2 years
Incidence of immune-related adverse events
Time frame: 2 years
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 2 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor Cancer and Metastatic Solid Tumors, run by PENG YUAN at 1 site 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 15 inclusion and 26 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Xue Wang (86-010-87787242, wxyxyuki@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥3 irAEs (time frame: 2 years). 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 2 Jul 2025.