Advanced Malignant TumorsPhase 1/2NCT05396391
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing IAP0971 in people with Advanced Malignant Tumors, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
Trial summary
This is a Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Malignant Tumors
- What is being tested?
- IAP0971
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 22 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. Age 18 to 80 years, male or female. 2. Patients with histologically or cytologically confirmed advanced or unresectable solid tumors or and relapsed and/or refractory non-Hodgkin's lymphoma, who have progressed on or have been intolerant to standard treatment, or for whom no standard treatment exists.
- 3. Dose Escalation Phase (Part A)：At least one evaluable tumor lesion per RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas).
- Dose Expansion Phase (Part B)：At least one measurable tumor lesion per RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas).
- 4. Agree to provide previously stored tumor tissue specimens or perform biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 expression level detection.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. (see Appendix 3) 6. Adequate organ function: Hematological system (No blood transfusion or hematopoietic stimulating factor therapy within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L White blood cell count (WBC) ≥ 3.0 × 109/L Platelets (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Hepatic function Total bilirubin (TBIL) ≤ 3 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN; Aspartate aminotransferase (AST) ≤ 3 × ULN; Renal function Creatinine clearance (Ccr) (only calculated if creatinine > 3 × ULN) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula, see Appendix 7 for formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN 7. Expected survival time of more than 3 months. 8. Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partners during the trial and for at least 90 days after study drug administration; female patients of childbearing potential (see Appendix 8 for definition) must have a negative blood or urine pregnancy test 7 days before the first administration.
- 9. Subjects must be informed of the study prior to the trial and voluntarily sign a written informed consent form.
Who cannot join
- 1. Patients who have a severe hypersensitivity reaction to any monoclonal antibody (CTCAE 5.0 grade ≥ 3).
- 2. Patients who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatment within 4 weeks before the first administration, except for the following: Nitrosourea or mitomycin C was received within 6 weeks before the first administration; Oral fluoropyrimidines and small molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first administration.
- Chinese proprietary medicines with anti-tumor indications were received within 2 weeks before the first administration.
- 3. Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.
- 4. Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first administration, or require elective surgery during the trial.
- 5. Patients who have received systemic glucocorticoids (prednisone > 10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration; exclude the following conditions: topical, ophthalmic, intra-articular, intranasal or inhaled corticosteroid therapy; short-term use of glucocorticoid for preventive treatment (for example, prevention of contrast agent allergy).
Show all 15Show fewer
- 6. Patients who have received immunomodulatory drugs within 14 days before the first administration, including but not limited to thymosin, interleukin-2, interferon, etc.
- 7. Patients who have received live attenuated vaccines within 4 weeks before the first administration.
- 8. Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.
- 9. The adverse reactions caused by previous anti-tumor treatment have not recovered to CTCAE 5.0 grade ≤ 1 (except for toxicity without safety risk as judged by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).
- 10. Patients with active infection who need intravenous anti-infective therapy. 11. Patients with interstitial lung disease (except for radiation pulmonary fibrosis not requiring hormone therapy).
- 12. History of serious cardiovascular and cerebrovascular diseases, including but not limited to: Patients with severe cardiac rhythm or conduction abnormalities, such as arrhythmia requiring clinical intervention, second-degree to third-degree atrioventricular block; QT interval (QTcF) corrected by Fridericia's method > 470 ms (see Appendix 9 for calculation formula); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular and cerebrovascular events within 6 months prior to the first dose; Patients with heart failure with cardiac function class ≥ II according to New York Heart Association (NYHA) (see Appendix 4) or Left Ventricular Ejection Fraction (LVEF) < 50%; Clinically uncontrolled hypertension. 13. Patients who currently have active or have had autoimmune diseases that may have recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid diseases, type I Diabetics.
- 14. Patients who have received immunotherapy and developed irAE ≥3 or immune-related myocarditis ≥2.
- 15. Clinically uncontrolled effusion in the third space, which is not suitable for enrollment based on the investigator's judgment.
- 16. Known alcohol or drug dependence. 17. Patients with mental disorders or poor compliance. 18. Women who are pregnant or breastfeeding. 19. The subject has a history of other serious systemic diseases or other reasons that make the subject unsuitable for this clinical study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- 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 and Preliminary Effectiveness of IAP0971 in Patients With Advanced Malignant Tumors
This is a Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant 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，the Phase Ib dose extension study can be carried out in the MTD dose which can be achieved from Phase 1a. After Phase Ia \& Ib are completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.
- Conditions
- Advanced Malignant Tumors
- Being tested
- IAP0971
- Keywords
- PD1, IL15, Advanced Malignant Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IAP0971Drug
IAP0971 should be subcutaneous injected，q2w
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia - Dose escalation | Experimental | The goal of the Dose Escalation Phase (Part A) is to initially characterize the safety and tolerability of IAP0971, and more specifically to describe the DLTs for each dose level studied and to define the MTD based on the frequency of the occurrence of DLTs in each cohort during the DLT evaluation period. Receives: Drug: IAP0971 |
| Phase Ib - Dose extension | Experimental | During the Dose Expansion Phase , patients will be enrolled to receive IAP0971 at the MTD established from the Dose Escalation Phase of the study. Receives: Drug: IAP0971 |
| Phase IIa - Clinical Exploratory Stage | Experimental | After finishing Phase 1, invesigators will discuss with the sponsor about how to carry out the Phase IIa due to the results acheived from Phase I. Receives: Drug: IAP0971 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of IAP0971 (Phase I)
MTD/RP2D; Incidence and frequency of DLT; AE, SAE occurrence and frequency (according to NCI CTCAE 5.0).
Measured: Through finishing Phase I, an average of 1 year
To evaluate the effectiveness of IAP0971 (Phase IIa)
Objective response rate(ORR)
Measured: Until disease progression, assessed up to 3 years
Secondary outcomes (23)
Pharmacokinetics (PK) Cmax（Phase I)
PK parameters Cmax following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) Css,max（Phase I)
PK parameters Css,max following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Css,min（Phase I)
PK parameters Css,min following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Css,av（Phase I)
PK parameters Css,av following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) AUCss（Phase I)
PK parameters AUCss following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) CLss（Phase I)
PK parameters CLss following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Vss（Phase I)
PK parameters Vss following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) R（Phase I)
PK parameters R following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) DF（Phase I)
PK parameters DF following multiple doses
Measured: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Tmax（Phase I)
PK parameters Tmax following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) AUC0-t（Phase I)
PK parameters AUC0-t following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) AUC0-∞（Phase I)
PK parameters AUC0-∞ following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) CL（Phase I)
PK parameters CL following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) Vd（Phase I)
PK parameters Vd following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) t1/2（Phase I)
PK parameters t1/2 following single dose
Measured: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) λz（Phase I)
PK parameters λz following single dose
Measured: After single dose ,assessed up to 1 year
To evaluate the immunogenicity of IAP0971 in patients with advanced malignant tumors (Phase I)
Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAb) against IAP0971
Measured: After finishing Phase I, an average of 1 year
To evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase I)
Overall survival (OS) according to RECIST 1.1 or Lugano 2014
Measured: After finishing Phase I, an average of 1 year
To evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase I)
Objective response rate (ORR) according to RECIST 1.1 or Lugano 2014
Measured: After finishing Phase I, an average of 1 year
To evaluate the immunogenicity of IAP0971 in patients with advanced malignant tumors (Phase IIa)
Incidence of anti-drug antibody (ADA) and neutralizing antibodies (NAb) against IAP0971
Measured: After finishing Phase IIa, assessed up to 3 years
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)
PFS according to RECIST 1.1 or Lugano 2014
Measured: After finishing Phase IIa, assessed up to 3 years
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)
DCR according to RECIST 1.1 or Lugano 2014
Measured: After finishing Phase IIa, assessed up to 3 years
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)
OS according to RECIST 1.1 or Lugano 2014
Measured: After finishing Phase IIa, assessed up to 3 years
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 start22 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Malignant TumorsStudies 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
- 140 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396391
- Sponsor's protocol ID
- IAP0971-I/IIa
- Status last verified
- Jul 2023
- First submitted
- 19 May 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Shen Z, Jiang X, Huang Z, Wu C, Jiang D, Yin L. Preclinical evaluation of IAP0971, a novel immunocytokine that binds specifically to PD1 and fuses IL15/IL15Ralpha complex. Antib Ther. 2022 Nov 17;6(1):38-48. doi: 10.1093/abt/tbac031. eCollection 2023 Jan.
PubMed 36683766
Study at a glance
From the registry record, last updated by the sponsor on 20 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 and Preliminary Effectiveness of IAP0971 in Patients With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT05396391
- Acronym / sponsor ID
- IAP0971-I/IIa
- Conditions
- Advanced Malignant Tumors
- Keywords
- PD1, IL15, Advanced Malignant Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 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 Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant 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，the Phase Ib dose extension study can be carried out in the MTD dose which can be achieved from Phase 1a. After Phase Ia \& Ib 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia - Dose escalation | Experimental | Drug: IAP0971The goal of the Dose Escalation Phase (Part A) is to initially characterize the safety and tolerability of IAP0971, and more specifically to describe the DLTs for each dose level studied and to define the MTD based on the frequency of the occurrence of DLTs in each cohort during the DLT evaluation period. |
| Phase Ib - Dose extension | Experimental | Drug: IAP0971During the Dose Expansion Phase , patients will be enrolled to receive IAP0971 at the MTD established from the Dose Escalation Phase of the study. |
| Phase IIa - Clinical Exploratory Stage | Experimental | Drug: IAP0971After finishing Phase 1, invesigators will discuss with the sponsor about how to carry out the Phase IIa due to the results acheived from Phase I. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age 18 to 80 years, male or female. 2. Patients with histologically or cytologically confirmed advanced or unresectable solid tumors or and relapsed and/or refractory non-Hodgkin's lymphoma, who have progressed on or have been intolerant to standard treatment, or for whom no standard treatment exists.
- 3. Dose Escalation Phase (Part A)：At least one evaluable tumor lesion per RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas).
- Dose Expansion Phase (Part B)：At least one measurable tumor lesion per RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas).
- 4. Agree to provide previously stored tumor tissue specimens or perform biopsy to collect tumor lesion tissue and send it to the central laboratory for PD-L1 expression level detection.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. (see Appendix 3) 6. Adequate organ function: Hematological system (No blood transfusion or hematopoietic stimulating factor therapy within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L White blood cell count (WBC) ≥ 3.0 × 109/L Platelets (PLT) ≥ 75 × 109/L Hemoglobin (Hb) ≥ 90 g/L Hepatic function Total bilirubin (TBIL) ≤ 3 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN; Aspartate aminotransferase (AST) ≤ 3 × ULN; Renal function Creatinine clearance (Ccr) (only calculated if creatinine > 3 × ULN) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula, see Appendix 7 for formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN 7. Expected survival time of more than 3 months. 8. Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partners during the trial and for at least 90 days after study drug administration; female patients of childbearing potential (see Appendix 8 for definition) must have a negative blood or urine pregnancy test 7 days before the first administration.
Key exclusion criteria (15 listed)
- 1. Patients who have a severe hypersensitivity reaction to any monoclonal antibody (CTCAE 5.0 grade ≥ 3).
- 2. Patients who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatment within 4 weeks before the first administration, except for the following: Nitrosourea or mitomycin C was received within 6 weeks before the first administration; Oral fluoropyrimidines and small molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first administration.
- Chinese proprietary medicines with anti-tumor indications were received within 2 weeks before the first administration.
- 3. Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.
- 4. Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first administration, or require elective surgery during the trial.
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 |
|---|---|---|
| IAP0971IAP0971 should be subcutaneous injected，q2w | Drug | Phase IIa - Clinical Exploratory Stage, Phase Ia - Dose escalation, Phase Ib - Dose extension |
Primary outcome
To evaluate the safety of IAP0971 (Phase I)
Time frame: Through finishing Phase I, an average of 1 year
MTD/RP2D; Incidence and frequency of DLT; AE, SAE occurrence and frequency (according to NCI CTCAE 5.0).
To evaluate the effectiveness of IAP0971 (Phase IIa)
Time frame: Until disease progression, assessed up to 3 years
Objective response rate(ORR)
23 secondary outcomes
Pharmacokinetics (PK) Cmax（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) Css,max（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Css,min（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Css,av（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) AUCss（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) CLss（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Vss（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) R（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) DF（Phase I)
Time frame: After multiple doses ,assessed up to 1 year
Pharmacokinetics (PK) Tmax（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) AUC0-t（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) AUC0-∞（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) CL（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) Vd（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) t1/2（Phase I)
Time frame: After single dose ,assessed up to 1 year
Pharmacokinetics (PK) λz（Phase I)
Time frame: After single dose ,assessed up to 1 year
To evaluate the immunogenicity of IAP0971 in patients with advanced malignant tumors (Phase I)
Time frame: After finishing Phase I, an average of 1 year
To evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase I)
Time frame: After finishing Phase I, an average of 1 year
To evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase I)
Time frame: After finishing Phase I, an average of 1 year
To evaluate the immunogenicity of IAP0971 in patients with advanced malignant tumors (Phase IIa)
Time frame: After finishing Phase IIa, assessed up to 3 years
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)
Time frame: After finishing Phase IIa, assessed up to 3 years
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)
Time frame: After finishing Phase IIa, assessed up to 3 years
o evaluate the effectiveness of IAP0971 in patients with advanced malignant tumors (Phase IIa)
Time frame: After finishing Phase IIa, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 36683766Chen J, Shen Z, Jiang X, Huang Z, Wu C, Jiang D, Yin L. Preclinical evaluation of IAP0971, a novel immunocytokine that binds specifically to PD1 and fuses IL15/IL15Ralpha complex. Antib Ther. 2022 Nov 17;6(1):38-48. doi: 10.1093/abt/tbac031. eCollection 2023 Jan.
- Individual participant dataSharing planned: No
Related trials for Advanced Malignant Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
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
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
GST101 in Participants With RAS-Mutant Advanced Solid Tumors
RAS-mutant Advanced Solid Tumors
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
1 site 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 IAP0971 in people with Advanced Malignant Tumors, run by SUNHO（China）BioPharmaceutical CO., Ltd. 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 6 inclusion and 15 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 20 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 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.
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 of IAP0971 (Phase I) (time frame: Through finishing Phase I, 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?
On the ClinicalTrials.gov record for NCT05396391, which also lists 1 linked publication.
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 20 Jul 2023.