Advanced Malignant Solid TumorPhase 1/2NCT05396339
A Clinical Trial to Evaluate the Effect of IAE0972 in Patients With Advanced Malignant Solid Tumors.
A Phase 1/2 study testing IAE0972 in people with Advanced Malignant Solid Tumor, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 2 sites in China.
Trial summary
This is a Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- IAE0972
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 24 Jun 2022to 30 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
- 2. Male or female, of any race, aged between 18 years and 80 years; 3. With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either refractory to standard therapy or for which no effective therapy was available.
- 4. Measurable disease as determined by RECIST version 1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy ≥ 12 weeks. 7. Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1 (with exception of ≤ Grade 2 alopecia, stable sensory neuropathy, or stable electrolyte disturbances that are managed by supplementation).
- 8. Acceptable laboratory parameters as follows:
- Platelet count (PLT) ≥ 90 × 109/L without transfusion within 2 weeks prior to the initiation of investigational product.
Show all 14Show fewer
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L in the absence of any growth factor support within 2 weeks prior to the initiation of investigational product.
- International normalized ratio of prothrombin time (INR) ≤ 1.5 × upper limit of normal (ULN), activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Hemoglobin (HGB) ≥ 90 g/L.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN; for patients with hepatic metastases, ALT and AST ≤ 5.0 × ULN.
- Total bilirubin ≤ 1.5 × ULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin is within normal limits.
- Serum creatinine < 1.5 × ULN, or estimated creatinine clearance ≥ 60 mL/min as measured or calculated using the Cockcroft-Gault formula.
- 9. Female patients of childbearing potential (not surgically sterilized and between menarche and 1- year postmenopause) must have a negative serum or urine pregnancy test performed within 7 days prior to the initiation of investigational product administration. Further, female patients of childbearing potential must agree to use highly effective contraceptive measures (include hormonal contraceptives, intrauterine device or system, vasectomy, or tubal ligation) from the time of consent through 3 months after discontinuation of investigational product administration.
- 10. Male patients with partners of childbearing potential must use barrier contraception. In addition, male patients should also have their partners use another method of contraception from the time of consent through 3 months after discontinuation of investigational product administration.
Who cannot join
- 1. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IAE0972.
- 2. History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease free for two years, or successfully treated for non-melanoma skin cancer, localized prostate cancer (Gleason Score < 6) or carcinoma in situ, for example cervical cancer in situ, are eligible.
- 3. Treatment with any systemic anti-neoplastic therapy, radiation therapy or investigational therapy within 4 weeks prior to the initiation of investigational product administration, with the following exceptions:
- Nitrosourea or mitomycin C should be within 6 weeks prior to the initiation of investigational product administration.
- Oral fluoropyrimidines and small molecule targeted drugs should be within 2 weeks or 5 half-lives (whichever is later) prior to the initiation of investigational product administration.
- 4. History of trauma or major surgery within 4 weeks prior to the initiation of investigational product administration.
Show all 29Show fewer
- 5. Treatment with corticosteroids (prednisone ≥ 10 mg per day or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of investigational product administration. Steroids for topical, ophthalmic, inhaled or nasal administration are allowed.
- 6. Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.
- 7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
- 8. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
- 9. Active brain or leptomeningeal metastases. Patients with brain metastases are eligible if these have been treated and MRI or CT shows no evidence of progression for at least 8 weeks after treatment completion and within 4 weeks prior to the initiation of investigational product. Patients are not eligible if they required high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to the initiation of investigational product.
- 10. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of investigational product. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of investigational product.
- 11. Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR).
- 12. Known positive testing for human immunodeficiency virus (HIV) or history of acquired immune deficiency syndrome (AIDS).
- 13. Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
- 14. History of clinically significant cardiovascular disease including but not limited to:
- <!-- -->
- Myocardial infarction or unstable angina within the 6 months prior to the initiation of investigational product.
- Stroke or transient ischemic attack within 6 months prior to the initiation of investigational product.
- Clinically significant cardiac arrhythmias, or a QTc prolongation to > 470 millisecond (ms) corrected by Fridericia's method based on a 12-lead electrocardiogram (ECG) in screening.
- Uncontrolled hypertension: systolic blood pressure (SBP) >180 mmHg, diastolic blood pressure (DBP) >100 mmHg.
- Congestive heart failure (New York Heart Association [NYHA] class III-IV).
- Pericarditis or clinically significant pericardial effusion.
- Myocarditis.
- Left ventricle ejection fraction (LVEF) < 50% by echocardiogram. 15. Any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of autoimmune disease that are now clinically stable with replacement therapy and by laboratory testing.
- 16. History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2 immune-associated myocarditis accompanied with immunotherapy.
- 17. Clinically uncontrolled effusion in the third space. 18. Known alcohol or drug dependence. 19. Dementia or altered mental status that would preclude understanding and rendering of informed consent.
- 20. The female patient who is pregnant or breastfeeding, or expecting to conceive, AND the male patient who is expecting to father children within the projected duration of the trial, starting with the screening visit through 90 days after the last dose of trial treatment.
- 21. Any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study or confound the results of the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Affilated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Yuping Sun, master, +86-0531-67627156, 13370582181@163.com
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li, master, +86-021-38804518, lijin@csco.org.cn
About this study
Official title: A Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.
This is a Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.
Read the detailed description
The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).First, the Phase Ia dose escalation will be carried out. After finishing the Phase 1a dose escalation, the Phase Ib dose extension study can be carried out in the MTD dose which is obtained from Phase 1a . After Phase Ia \&1b are completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- IAE0972
- Keywords
- EGFR, IL10, Advanced Malignant Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAE0972Drug
IAE0972 is an investigational product
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia - Dose escalation(Acceleration Stage) | Experimental | Phase Ia is an open, non-random, single-arm dose escalation design. Receives: Drug: IAE0972 |
| Phase Ia - Dose escalation(3+3 Stage) | Experimental | Phase Ia is an open, non-random, single-arm dose escalation design. Receives: Drug: IAE0972 |
| Phase Ib - Dose extension | Experimental | Phase Ib is an open, non-random, single-arm, multi-center research design. Receives: Drug: IAE0972 |
| Phase IIa - Clinical Exploratory Stage | Experimental | The Phase IIa is planned to be divided into three indication groups, all of which are open, non-randomized, single-arm research design. Receives: Drug: IAE0972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of IAE0972 in Phase I
MTD/R2PD ,Incidence and frequency of DTL; AE，SAE occurrence and frequency (according to NCI CTCAE 5.0)
Measured: 28 days after last medication, an average of 1 year
Objective response rate (ORR) in Phase IIa
To explore the effectiveness of IAE0972.
Measured: Baeline until disease progression, assessed up to 36 months
Secondary outcomes (26)
Pharmacokinetic (PK) Cmax
PK parameters Cmax following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) Css,max
PK parameters Css,max following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Css,min
PK parameters Css,min following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Css,av
PK parameters Css,av following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) AUCss
PK parameters AUCss following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) CLss
PK parameters CLss following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Vss
PK parameters Vss following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) R
PK parameters R following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) DF
PK parameters DF following multiple doses
Measured: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Cmin
PK parameters Cmin following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) Tmax
PK parameters Tmax following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) AUC0-t
PK parameters AUC0-t following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) AUC0-∞
PK parameters AUC0-∞ following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) CL
PK parameters CL following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) Vd
PK parameters Vd following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) t1/2
PK parameters t1/2 following single dose
Measured: after single dose , an average of 1 year
Pharmacokinetic (PK) λz
PK parameters λz following single dose
Measured: after single dose , an average of 1 year
Objective response rate (ORR) (Phase I )
To explore the preliminary effectiveness of IAE0972.
Measured: Baeline until disease progression or death, an average of 1 year
Overall survival (OS) (Phase I )
To explore the preliminary effectiveness of IAE0972.
Measured: Baeline until disease progression or death, an average of 1 year
Disease control rate (DCR) (Phase I )
To explore the preliminary effectiveness of IAE0972.
Measured: Baeline until disease progression or death, an average of 1 year
To evaluate the Immunogenicity of IAE0972 in patients with advanced malignant solid tumors (Phase I )
The frequency of anti-drug antibodies(ADA) against IAE0972
Measured: Before each administration of dose cycle，an average of 1 year
Progression-free survival（PFS) in Phase II
To explore the effectiveness of IAE0972.
Measured: Baeline until disease progression or death,assessed up to 36 months
Overall survival (OS)in Phase II
To explore the effectiveness of IAE0972.
Measured: Baeline until disease progression or death,assessed up to 36 months
Disease control rate (DCR) in Phase II
To explore the effectiveness of IAE0972.
Measured: Baeline until disease progression or death,assessed up to 36 months
Immunogenicity of IAE0972 (Phase II )
The frequency of anti-drug antibodies(ADA) against IAE0972
Measured: Before each administration of dose cycle,assessed up to 36 months
Incidence of adverse event (AEs) and SAEs (Phase II)
To investigate the safety characteristics
Measured: After last medication,assessed 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.
- First posted31 May 2022
- Study start24 Jun 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 Nov 2024 (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 TumorStudies of the same condition, open and under way.
- More trials run by SUNHO（China）BioPharmaceutical 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, M.D., Principal investigator, Shanghai East HospitalYuping Sun, M.D., Principal investigator, Affilated Cancer Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396339
- Sponsor's protocol ID
- IAE0972-I/IIa
- Status last verified
- Jul 2023
- First submitted
- 19 May 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.
- ClinicalTrials.gov ID
- NCT05396339
- Acronym / sponsor ID
- IAE0972-I/IIa
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- EGFR, IL10, Advanced Malignant Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 31 May 2022 (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 is a Phase I/IIa Clinical Trial to Evaluate the Safety,Tolerability,Pharmacokinetics and Preliminary Effectiveness of IAE0972 in Patients With Advanced Malignant Solid Tumors.
Detailed description
The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).First, the Phase Ia dose escalation will be carried out. After finishing the Phase 1a dose escalation, the Phase Ib dose extension study can be carried out in the MTD dose which is obtained from Phase 1a . After Phase Ia \&1b are completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ia - Dose escalation(Acceleration Stage) | Experimental | Drug: IAE0972Phase Ia is an open, non-random, single-arm dose escalation design. |
| Phase Ia - Dose escalation(3+3 Stage) | Experimental | Drug: IAE0972Phase Ia is an open, non-random, single-arm dose escalation design. |
| Phase Ib - Dose extension | Experimental | Drug: IAE0972Phase Ib is an open, non-random, single-arm, multi-center research design. |
| Phase IIa - Clinical Exploratory Stage | Experimental | Drug: IAE0972The Phase IIa is planned to be divided into three indication groups, all of which are open, non-randomized, single-arm research design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
- 2. Male or female, of any race, aged between 18 years and 80 years; 3. With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either refractory to standard therapy or for which no effective therapy was available.
- 4. Measurable disease as determined by RECIST version 1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy ≥ 12 weeks. 7. Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1 (with exception of ≤ Grade 2 alopecia, stable sensory neuropathy, or stable electrolyte disturbances that are managed by supplementation).
- 9. Female patients of childbearing potential (not surgically sterilized and between menarche and 1- year postmenopause) must have a negative serum or urine pregnancy test performed within 7 days prior to the initiation of investigational product administration. Further, female patients of childbearing potential must agree to use highly effective contraceptive measures (include hormonal contraceptives, intrauterine device or system, vasectomy, or tubal ligation) from the time of consent through 3 months after discontinuation of investigational product administration.
Key exclusion criteria (29 listed)
- 1. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IAE0972.
- 2. History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease free for two years, or successfully treated for non-melanoma skin cancer, localized prostate cancer (Gleason Score < 6) or carcinoma in situ, for example cervical cancer in situ, are eligible.
- 3. Treatment with any systemic anti-neoplastic therapy, radiation therapy or investigational therapy within 4 weeks prior to the initiation of investigational product administration, with the following exceptions:
- 4. History of trauma or major surgery within 4 weeks prior to the initiation of investigational product administration.
- 5. Treatment with corticosteroids (prednisone ≥ 10 mg per day or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of investigational product administration. Steroids for topical, ophthalmic, inhaled or nasal administration are allowed.
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 |
|---|---|---|
| IAE0972IAE0972 is an investigational product | Drug | Phase IIa - Clinical Exploratory Stage, Phase Ia - Dose escalation(3+3 Stage), Phase Ia - Dose escalation(Acceleration Stage), Phase Ib - Dose extension |
Primary outcome
To evaluate the safety and tolerability of IAE0972 in Phase I
Time frame: 28 days after last medication, an average of 1 year
MTD/R2PD ,Incidence and frequency of DTL; AE，SAE occurrence and frequency (according to NCI CTCAE 5.0)
Objective response rate (ORR) in Phase IIa
Time frame: Baeline until disease progression, assessed up to 36 months
To explore the effectiveness of IAE0972.
26 secondary outcomes
Pharmacokinetic (PK) Cmax
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) Css,max
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Css,min
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Css,av
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) AUCss
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) CLss
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Vss
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) R
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) DF
Time frame: after multiple doses , an average of 1 year
Pharmacokinetic (PK) Cmin
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) Tmax
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) AUC0-t
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) AUC0-∞
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) CL
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) Vd
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) t1/2
Time frame: after single dose , an average of 1 year
Pharmacokinetic (PK) λz
Time frame: after single dose , an average of 1 year
Objective response rate (ORR) (Phase I )
Time frame: Baeline until disease progression or death, an average of 1 year
Overall survival (OS) (Phase I )
Time frame: Baeline until disease progression or death, an average of 1 year
Disease control rate (DCR) (Phase I )
Time frame: Baeline until disease progression or death, an average of 1 year
To evaluate the Immunogenicity of IAE0972 in patients with advanced malignant solid tumors (Phase I )
Time frame: Before each administration of dose cycle，an average of 1 year
Progression-free survival（PFS) in Phase II
Time frame: Baeline until disease progression or death,assessed up to 36 months
Overall survival (OS)in Phase II
Time frame: Baeline until disease progression or death,assessed up to 36 months
Disease control rate (DCR) in Phase II
Time frame: Baeline until disease progression or death,assessed up to 36 months
Immunogenicity of IAE0972 (Phase II )
Time frame: Before each administration of dose cycle,assessed up to 36 months
Incidence of adverse event (AEs) and SAEs (Phase II)
Time frame: After last medication,assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignant Solid Tumor
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Advanced Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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. This study is not recruiting at the moment.
Jin Li, M.D. principal investigator
Shanghai East Hospital
Yuping Sun, M.D. principal investigator
Affilated Cancer Hospital of Shandong First Medical University
2 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 IAE0972 in people with Advanced Malignant Solid Tumor, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 2 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 14 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minwei Manager (18068131816, shenminwei@sunho-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of IAE0972 in Phase I (time frame: 28 days after last medication, an average of 1 year). The study lists 2 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 19 Jul 2023.