Advanced Malignant TumorsPhase 1/2NCT06223841

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a Phase Ib/II 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 75 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: 50 participants
Where: 1 siteChina
Study dates: 1 Mar 2024to 1 Mar 2027
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age 18 to 75years, male or female.
2. Phase Ib:With advanced or metastatic malignant solid tumor confirmed by histopathology, the standard treatment fails, or there is no standard treatment plan, or standard treatment is not applicable at this stage, or the patient refuses the standard treatment, or the investigator evaluates the patient who can benefit from this treatment.
3.Phae II: Confirmed by histopathology that it is not feasible to perform complete resection and cannot be connected. Locally advanced (stage IIIB or IIIC) or metastatic (IV) after radical concurrent radiotherapy and chemotherapy Stage) non-small cell lung cancer (NSCLC). Note: For unacceptable radical synchronization/sequencing.Subjects with locally advanced stage IIIB/IIIC of radiotherapy and chemotherapy need to be evaluated by relevant professional doctors. And provide written records to confirm.
4.Phae II: Never received systemic anti-tumor therapy for locally advanced or metastatic NSCLC before. Tumor treatment(received adjuvant/neoadjuvant chemotherapy or radical treatment for locally advanced diseases) .Patients with synchronous or sequential radiotherapy and chemotherapy and disease progression occurred after the last treatment ≥6 months).
5.Phase II: PD-L1 was positive (TPS≥50%) by IHC, and the patient was immunohistochemical. Epidermal growth factor receptor (EGFR) and anaplasticlymphomakinase (ALK) were negative.
6. At least one measurable tumor lesion per RECIST 1.1 (solid tumors).

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7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 7. The estimated survival time is ≥3 months.8.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.
8. Expected survival time of more than 3 months.
9. 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.
10. Eligible patients with fertility (male and female) must agree that during and at the end of the trial.Use reliable contraceptive methods (hormones or screens) with their partners for at least 6 months after taking the drug.Obstacle law or abstinence); Blood of female patients of childbearing age within 7 days before the first use of the study drug.The pregnancy test must be negative.
11.Subjects must be informed of the study prior to the trial and voluntarily sign a written informed consent form.

Who cannot join

1.Phase II: Pathohistologically confirmed with small cell lung cancer components, or sarcomatoid lesions.
2. Phase II : Previous immunotherapy, including immune checkpoint inhibitors (such as PD-1/PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonist (such as:ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, etc.
3. Phase Ib: 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.
4. Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.
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).
6.The adverse reactions of previous anti-tumor treatments have not recovered to CTCAE 5.0 grade evaluation ≤1 grade.Or the relevant provisions of the selection criteria (except for the toxicity that the researcher judges to have no safety risk).

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7. 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.
8.Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.
9. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms.
10. active infection and currently needs intravenous anti-infection treatment.
11. immunodeficiency disease, including HIV antibody positive.
12. Active hepatitis B (HBsAg positive and HBV-DNA positive or above normal) Limit), active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive Or greater than the upper limit of normal value).
13.Vaccinated with any live vaccine within 4 weeks before the first use of the study drug.
14. Hypersensitivity to any antibody drugs (NCI CTCAE 5.0 grade evaluation ≥3 Grade), or active ingredients or inactive excipients of research drugs and PD-1/PD-L1 inhibitors.
15.With serious and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease Etc.); Or other serious effects that may interfere with the detection or treatment of drug-related pulmonary toxicity. Moderate and severe lung diseases with respiratory function.
16. 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.
17. 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.
18. Suffering from other malignant tumors within 5 years before the start of drug administration, except for the following cases: Malignant tumor that can be expected to be cured after treatment (including but not limited to fully treated thyroid gland) cervical carcinoma in situ, basal or squamous cell skin cancer or breast treated by radical surgery. Ductal carcinoma in situ, etc.).
19. Clinically uncontrolled effusion in the third space, which is not suitable for enrollment based on the investigator's judgment.
20. Known alcohol or drug dependence.
21. Patients with mental disorders or poor compliance.
22. Women who are pregnant or breastfeeding.
23. 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. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Kai Yuan Shi, doctor, 8610-87788495, cancergcp@163.com
Recruiting

Other trials in China

About this study

Official title: A Clinical Trial of Phase Ib/II to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

This is a Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.

Conditions: Advanced Malignant Tumors
Being tested: IAP0971

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，q3w

Study groups in NCT06223841
Study group	Role	What they receive
Phase Ib - Dose escalation	Experimental	Not described Receives: Drug: IAP0971
Phase II - Clinical Exploratory Stage	Experimental	Not described Receives: Drug: IAP0971

What is being measured

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

Frequency of adverse events (AEs) and SAEs (Phase Ib)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Dose limiting toxicities (DLTs) (Phase Ib)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Measured: 21 days after first dose
PFS in dose expansion (Phase II)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression

Secondary outcomes (24)

Pharmacokinetic (PK) Cmax (Phase Ib)
PK parameters (Cmax) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Cmin (Phase Ib)
PK parameters (Cmin) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Tmax (Phase Ib)
PK parameters (Tmax) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUC 0-t (Phase Ib)
PK parameters (AUC 0-t) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUC 0-∞ (Phase Ib)
PK parameters (AUC 0-∞) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Vd (Phase Ib)
PK parameters (Vd) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) t1/2 (Phase Ib)
PK parameters (t1/2) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) λz (Phase Ib)
PK parameters (λz) following single dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,max
PK parameters (Css,max) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,min
PK parameters (Css,min) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,av
PK parameters (Css,av) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUCss
PK parameters (AUCss) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CKss
PK parameters (CLss) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK）Vss
PK parameters (Vss) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) R
PK parameters (R) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) DF
PK parameters (DF) following multiple dose.
Measured: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Objective response rate (ORR) in dose escalation (Phase Ib)
Tumor response based on RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ib)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Immunogenicity of IAH0968 (Phase Ib)
The frequency of anti-drug antibodies (ADA) against IAP0971.(Phase Ib)
Measured: 3 months after end event visit
ORR (Phase Ⅱ)
ORR as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase II)
OS as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase II)
DCR as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase II)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Immunogenicity of IAH0968 (Phase II)
The frequency of anti-drug antibodies (ADA) against IAP0971.(Phase II)
Measured: 3 months after end event visit

Timeline

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

1 Mar 20241 Mar 2027

First posted25 Jan 2024
Study start1 Mar 2024 (estimated)
Primary completion1 Mar 2026 (estimated)
Study completion1 Mar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06223841
Sponsor's protocol ID: IAP0971-202
Status last verified: Feb 2024
First submitted: 5 Jan 2024
Last updated: 20 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: we donot share.

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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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
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RAS-mutant Advanced Solid Tumors

All Advanced Malignant Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial of Phase Ib/II to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT06223841
Acronym / sponsor ID: IAP0971-202
Conditions: Advanced Malignant Tumors
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Mar 2024 (estimated)
Primary completion: 1 Mar 2026 (estimated)
Study completion: 1 Mar 2027 (estimated)
First posted: 25 Jan 2024 (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 Ib/II Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase Ib - Dose escalation	Experimental	Drug: IAP0971
Phase II - Clinical Exploratory Stage	Experimental	Drug: IAP0971

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

1. Age 18 to 75years, male or female.
2. Phase Ib:With advanced or metastatic malignant solid tumor confirmed by histopathology, the standard treatment fails, or there is no standard treatment plan, or standard treatment is not applicable at this stage, or the patient refuses the standard treatment, or the investigator evaluates the patient who can benefit from this treatment.
3.Phae II: Confirmed by histopathology that it is not feasible to perform complete resection and cannot be connected. Locally advanced (stage IIIB or IIIC) or metastatic (IV) after radical concurrent radiotherapy and chemotherapy Stage) non-small cell lung cancer (NSCLC). Note: For unacceptable radical synchronization/sequencing.Subjects with locally advanced stage IIIB/IIIC of radiotherapy and chemotherapy need to be evaluated by relevant professional doctors. And provide written records to confirm.
4.Phae II: Never received systemic anti-tumor therapy for locally advanced or metastatic NSCLC before. Tumor treatment(received adjuvant/neoadjuvant chemotherapy or radical treatment for locally advanced diseases) .Patients with synchronous or sequential radiotherapy and chemotherapy and disease progression occurred after the last treatment ≥6 months).
5.Phase II: PD-L1 was positive (TPS≥50%) by IHC, and the patient was immunohistochemical. Epidermal growth factor receptor (EGFR) and anaplasticlymphomakinase (ALK) were negative.

Key exclusion criteria (23 listed)

1.Phase II: Pathohistologically confirmed with small cell lung cancer components, or sarcomatoid lesions.
2. Phase II : Previous immunotherapy, including immune checkpoint inhibitors (such as PD-1/PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonist (such as:ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, etc.
3. Phase Ib: 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.
4. Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.
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).

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，q3w	Drug	Phase II - Clinical Exploratory Stage, Phase Ib - Dose escalation

Primary outcome

Frequency of adverse events (AEs) and SAEs (Phase Ib)
Time frame: 3 months after end event visit
To investigate the safety characteristics.
Dose limiting toxicities (DLTs) (Phase Ib)
Time frame: 21 days after first dose
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
PFS in dose expansion (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.

24 secondary outcomes

Pharmacokinetic (PK) Cmax (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Cmin (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Tmax (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUC 0-t (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUC 0-∞ (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Vd (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) t1/2 (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) λz (Phase Ib)
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,max
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,min
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Css,av
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUCss
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CKss
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK）Vss
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) R
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) DF
Time frame: Day1，2，3，4，6，7，11，14，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Objective response rate (ORR) in dose escalation (Phase Ib)
Time frame: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ib)
Time frame: 3 months after end event visit
Immunogenicity of IAH0968 (Phase Ib)
Time frame: 3 months after end event visit
ORR (Phase Ⅱ)
Time frame: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase II)
Time frame: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase II)
Time frame: 3 months after end event visit
Immunogenicity of IAH0968 (Phase II)
Time frame: 3 months after end event visit

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 20 Feb 2024.
Individual participant dataSharing planned: No. we donot share.

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)
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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.

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

8610-87788495

cancergcp@163.com

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 11 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 20 Feb 2024. 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) and SAEs (Phase Ib) (time frame: 3 months after end event visit). The study lists 3 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 NCT06223841.

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 Feb 2024.