Advanced Malignant TumorsPhase 1/2NCT05991583
A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors
A Phase 1/2 study testing IBB0979 in people with Advanced Malignant Tumors, run by SUNHO（China）BioPharmaceutical CO., Ltd. at 1 site in China.
Trial summary
This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid 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?
- IBB0979
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2023to 30 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 80 years old.
- With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate.
- There is at least one assessable tumor lesion in the Dose Escalation Phase and at least one measurable lesion in the Dose Expansion Phase According to RECIST 1.1 (tumor lesions located in the previous radiation therapy area or other local regional treatment area generally not be considered as measurable lesions, unless the lesion has progression or persists after three months of radiation therapy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
- Adequate organ functions:
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- Hematologic system (no transfusion or hematopoietic-stimulating factor therapy within 14 days): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 90 × 109/L, hemoglobin (HGB) ≥ 90 g/L.
- Liver function: total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal values (ULN), except for Gilbert's syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN, liver metastases or liver cancer patients with ALT and AST ≤ 5.0 × ULN.
- Renal function: estimated creatinine clearance (Ccr) ≥ 50 mL/min (calculated according to the Cockcroft-Gault formula).
- Thrombin function: international normalized ratio of prothrombin (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Eligible patients with fertility (male and female) must agree to use reliable contraceptive measures (include hormonal contraceptives, barrier contraception or abstinence) with their partners from the time of consent through 90 days after discontinuation of investigational product administration. Female patients of childbearing potential (not surgically sterilized and between menarche and 1- year postmenopause) must have a negative serum pregnancy test within 7 days prior to the initiation of investigational product administration.
- Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures.
Who cannot join
- Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
- History of anti-tumor therapy (chemotherapy within 3 weeks or radiotherapy, biological therapy, endocrine therapy, targeted 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 prior to the initiation of investigational product administration.
- History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
- History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.
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- History of systemic 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, intraarticular, inhaled or nasal administration are allowed.
- 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.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.
- History of prior allogeneic stem-cell or solid organ transplantation.
- The adverse effects of previous anti-tumor therapy have not yet returned to ≤ Grade 1 (NCI-CTCAE 5.0) or rules of the inclusion criteria (with exception of that the investigator judged to be without safety risks, such as hair loss, Grade 2 peripheral neurotoxicity, stable hypothyroidism with hormone replacement therapy, etc.).
- Active brain or leptomeningeal metastases with clinical symptoms. 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.
- Evidence of active infection requiring intravenous anti-infective therapy.
- Active hepatitis B (HBsAg-positive, and HBV-DNA> 500 IU/mL or lower limit of study site [only if the lower limit of study site is above 500 IU/mL]), active hepatitis C (HCV-RNA> lower limit of study site).
- Currently has interstitial lung disease (with exception of radiation pulmonary fibrosis that requires no hormone therapy).
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II/III-degree atrioventricular block, etc.
- The mean QT interval (QTcF) > 470 ms corrected by Fridericia's method.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of ≥ grade 3 within 6 months prior to the initiation of investigational product.
- Congestive heart failure (New York Heart Association [NYHA] class ≥ grade II) or left ventricle ejection fraction (LVEF) < 50%, or other structural heart disease at high risk by the investigator.
- Clinically uncontrolled hypertension.
- Active or suspected autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), with exception of clinically stable autoimmune thyroid disease, type I diabetes, vitiligo, cured atopic dermatitis in children and psoriasis without systemic treatment (within the past 2 years).
- History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2 immune-associated myocarditis accompanied with immunotherapy, with exception of ≥ Grade 3 immune-associated thyrotoxicosis.
- History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease free for two years for non-melanoma skin cancer, localized prostate cancer or carcinoma in situ (e.g., cervical cancer in situ), etc.
- Clinically uncontrolled effusion in the third space, which is unsuitable for participation in the study by the investigator.
- Known alcohol or drug dependence.
- History of mental disorder or poor adherence.
- The female patient who is pregnant or breastfeeding. History of other severe systemic disease, or any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study.
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
- 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/II Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBB0979 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a Phase 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.
Read the detailed description
The study consists of Dose Escalation Phase, Dose Expansion Phase and Clinical Exploration Phase.
Dose Escalation Phase：This phase is an open-label, non-randomized, multicenter, dose-escalation study. From the starting dose of 0.01 mg/kg, an accelerated titration combined with a "3+3" design will be adopted.
Dose Expansion Phase：The application of Dose Expansion Phase can be discussed by investigator and sponsor based on data obtained in Dose Escalation Phase. This phase is an open-label, non-randomized, multicenter study. 6 patients with locally advanced or metastatic solid tumors are expected to be enrolled at DRDE. Each treatment cycle is defined as 21 days, patient may receive treatment until withdrawal or Treatment Discontinuation.
Clinical Exploration Phase：After completing the dose escalation and expansion studies, the indication and study population can be discussed by the investigator and sponsor based on the efficacy and safety data that have been obtained.
- Conditions
- Advanced Malignant Tumors
- Being tested
- IBB0979
- Keywords
- Advanced Malignant Tumors, B7-H3, IL-10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBB0979Drug
IBB0979 should be subcutaneous injected，qw
| 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 IBB0979, 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: IBB0979 |
| Phase Ib - Dose extension | Experimental | During the Dose Expansion Phase , patients will be enrolled to receive IBB0979 at the MTD established from the Dose Escalation Phase of the study. Receives: Drug: IBB0979 |
| 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: IBB0979 |
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 Ⅰ)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Dose limiting toxicities (DLTs) (Phase Ⅰ)
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Measured: 21 days after first dose
Objective response rate (ORR) in dose expansion (Phase Ⅱa)
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
Measured: Baseline through up to 1 years or until disease progression
Secondary outcomes (25)
Pharmacokinetic (PK) Cmax (Phase Ⅰ)
PK parameters (Cmax) following single dose.following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (Cmin) following single dose.following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (Tmax) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (AUC 0-t) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (AUC 0-∞) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CL (Phase Ⅰ)
PK parameters (CL) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (Vd) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (t1/2) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
PK parameters (λz) following single dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 (Phase Ⅰ)
PK parameters (Css,max) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 (Phase Ⅰ)
PK parameters (Css,min) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 (Phase Ⅰ)
PK parameters (Css,av) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUCss (Phase Ⅰ)
PK parameters (AUCss) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CLss (Phase Ⅰ)
PK parameters (CLss) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Vss (Phase Ⅰ)
PK parameters (Vss) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) R (Phase Ⅰ)
PK parameters (R) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) DF (Phase Ⅰ)
PK parameters (DF) following multiple dose.
Measured: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Tumor response based on RECIST 1.1.
Measured: Baseline through up to 1 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)
To investigate the safety characteristics.
Measured: 3 months after end event visit
Immunogenicity of IBB0979
The frequency of anti-drug antibodies (ADA) against IBB0979.(Phase Ⅰb)
Measured: 3 months after end event visit
Progression free survival (PFS) (Phase Ⅱa)
PFS as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase Ⅱa)
OS as assessed using RECIST 1.1.
Measured: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase Ⅱa)
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 Ⅱa)
To investigate the safety characteristics.
Measured: Baseline through up to 2 years or until disease progression
Immunogenicity of IBB0979 (Phase Ⅱa)
The frequency of anti-drug antibodies (ADA) against IBB09798.(Phase Ⅱa)
Measured: Baseline through up to 2 years or until disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Jul 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Jin, M.D., Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991583
- Sponsor's protocol ID
- IBB0979-101
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBB0979 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05991583
- Acronym / sponsor ID
- IBB0979-101
- Conditions
- Advanced Malignant Tumors
- Keywords
- Advanced Malignant Tumors, B7-H3, IL-10
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- SUNHO（China）BioPharmaceutical CO., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (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 1/2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.
Detailed description
The study consists of Dose Escalation Phase, Dose Expansion Phase and Clinical Exploration Phase.
Dose Escalation Phase：This phase is an open-label, non-randomized, multicenter, dose-escalation study. From the starting dose of 0.01 mg/kg, an accelerated titration combined with a "3+3" design will be adopted.
Dose Expansion Phase：The application of Dose Expansion Phase can be discussed by investigator and sponsor based on data obtained in Dose Escalation Phase. This phase is an open-label, non-randomized, multicenter study. 6 patients with locally advanced or metastatic solid tumors are expected to be enrolled at DRDE. Each treatment cycle is defined as 21 days, patient may receive treatment until withdrawal or Treatment Discontinuation.
Clinical Exploration Phase：After completing the dose escalation and expansion studies, the indication and study population can be discussed by the investigator and sponsor based on the efficacy and safety data that have been obtained.
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: IBB0979The goal of the Dose Escalation Phase (Part A) is to initially characterize the safety and tolerability of IBB0979, 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: IBB0979During the Dose Expansion Phase , patients will be enrolled to receive IBB0979 at the MTD established from the Dose Escalation Phase of the study. |
| Phase IIa - Clinical Exploratory Stage | Experimental | Drug: IBB0979After 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 (12 listed)
- Male or female, 18 to 80 years old.
- With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate.
- There is at least one assessable tumor lesion in the Dose Escalation Phase and at least one measurable lesion in the Dose Expansion Phase According to RECIST 1.1 (tumor lesions located in the previous radiation therapy area or other local regional treatment area generally not be considered as measurable lesions, unless the lesion has progression or persists after three months of radiation therapy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 3 months.
Key exclusion criteria (28 listed)
- Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
- History of anti-tumor therapy (chemotherapy within 3 weeks or radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration, with the following exceptions:
- History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
- History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.
- History of systemic 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, intraarticular, 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 |
|---|---|---|
| IBB0979IBB0979 should be subcutaneous injected，qw | Drug | Phase IIa - Clinical Exploratory Stage, Phase Ia - Dose escalation, Phase Ib - Dose extension |
Primary outcome
Frequency of adverse events (AEs) and SAEs (Phase Ⅰ)
Time frame: 3 months after end event visit
To investigate the safety characteristics.
Dose limiting toxicities (DLTs) (Phase Ⅰ)
Time frame: 21 days after first dose
To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
Objective response rate (ORR) in dose expansion (Phase Ⅱa)
Time frame: Baseline through up to 1 years or until disease progression
To explore the clinical effectiveness. Tumor response based on RECIST 1.1.
25 secondary outcomes
Pharmacokinetic (PK) Cmax (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CL (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) AUCss (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) CLss (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) Vss (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) R (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 of each subsequent cycle (each cycle is 21 days), and at the End of Treatment visit, up to about 2 years
Pharmacokinetic (PK) DF (Phase Ⅰ)
Time frame: Day1，2，3，4，6，8，11，14，17，21 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 Ⅰ)
Time frame: Baseline through up to 1 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅰ)
Time frame: 3 months after end event visit
Immunogenicity of IBB0979
Time frame: 3 months after end event visit
Progression free survival (PFS) (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Overall survival (OS) (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Disease control rate (DCR) (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Incidence of adverse events (AEs) and SAEs (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
Immunogenicity of IBB0979 (Phase Ⅱa)
Time frame: Baseline through up to 2 years or until disease progression
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 17 Jan 2025.
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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.
Li Jin, 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 IBB0979 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 12 inclusion and 28 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 17 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jianxiang cao, M.D. (18018039840, caojianxiang@sunho-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (AEs) and SAEs (Phase Ⅰ) (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?
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 17 Jan 2025.