BridgeMD
New treatment option for Solid Tumor
Official title Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07589205
What this study is testing
What is Drug: IBI3028?
Drug: IBI3028 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this...
- Male or female participants aged 18 years or older;
- Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;
- Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose...
- ECOG PS（Eastern Cooperative Oncology Group Performance Status）score of 0-1;
You likely can't join if
- Participation in any other treatment clinical study other than an observational (non-treatment) study or during the follow-up period of an treatment...
- Prior anti-tumor therapy: Participants who have received cytotoxic therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first...
- Have received live vaccines within 4 weeks or tumor vaccines within 3 months prior to the first administration of the study drug, or plan to receive...
- Use of strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitors within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study...
- Adverse reactions caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 or baseline level according to NCI CTCAE v5.0...
- Known allergies, hypersensitivity, or intolerance to IBI3028 or its excipients (refer to the Investigator's Brochure);
See the full eligibility criteria
Who can join
- Be able to understand and sign written informed consent to participate in this study, including all assessments and procedures specified in this protocol;
- Male or female participants aged 18 years or older;
- Have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors;
- Have at least one evaluable lesion (dose escalation) or measurable lesion (dose expansion) as per RECIST v1.1 within 28 days prior to the first dose of IBI3028;
- ECOG PS（Eastern Cooperative Oncology Group Performance Status）score of 0-1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function as evidenced by :
- Hematological function: ANC(Absolute neutrophil count) ≥ 1.5 × 10 9 /L; platelet count (PLT) ≥ 90 × 10 9 /L; hemoglobin ≥ 9.0 g/dL, and without receiving granulocyte-colony stimulating factor (G-CSF)...
- Hepatic function: total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal) (≤ 3 × ULN for participants with Gilbert's syndrome); AST(Aspartate Aminotransferase) and ALT (Alanine Aminotransferase)≤ 2.5 × ULN in the absence of...
- Renal function: creatinine clearance ≥ 30 mL/min (using Cockcroft-Gault formula); urine protein \< 2+ or 24-h total urine protein \< 1 g;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by ECHO or MUGA(Multigated Acquisition), and no clinically significant ECG result;
- Coagulation function: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (participants receiving anticoagulant therapy with coagulation function within the range above...
- Pulmonary function: With at least the lowest level of pulmonary reserve, defined as Grade ≤ 1 dyspnea and blood oxygen saturation ≥ 95% in non-oxygen breathing state;
- Participants (both male and female participants) who will be not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study (from start of screening or within 2...
What rules you out
- Participation in any other treatment clinical study other than an observational (non-treatment) study or during the follow-up period of an treatment study;
- Prior anti-tumor therapy: Participants who have received cytotoxic therapy within 3 weeks or 5 half-lives (whichever is shorter) prior to the first administration of study intervention ; Participants who have received...
- Have received live vaccines within 4 weeks or tumor vaccines within 3 months prior to the first administration of the study drug, or plan to receive any live vaccines during the study;
- Use of strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitors within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study drug;
- Adverse reactions caused by previous anti-tumor treatments that have not resolved to Grade 0 or 1 or baseline level according to NCI CTCAE v5.0 before the first dose of the study drug (except for alopecia, fatigue...
- Known allergies, hypersensitivity, or intolerance to IBI3028 or its excipients (refer to the Investigator's Brochure);
- Have undergone major surgery (craniotomy, thoracotomy, or laparotomy, and other surgeries according to Investigators' opinion, excluding needle biopsy) within 4 weeks prior to the first dose of the investigational...
- Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (ie, no neurologic syndrome and metastases ≤1.5 cm in diameter) or stable disease after treatment as judged by the...
- Uncontrolled disease or condition, including:
- Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals prior to the first dose of the study drug;
- With known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive), for participants outside mainland China, participants with positive HIV antibody test at screening are eligible to...
- Acute or chronic active hepatitis B (HBsAg positive and/or HBcAb positive, and HBV DNA titer ≥ 10 4 copies/mL or ≥ 2000 IU/mL) or hepatitis C (HCV Ab positive, and HCV RNA \> 10 3 copies/mL or above the lower limit of...
- Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or receiving anti-tuberculosis treatment within 1 year before the first dose of the study drug;
- Uncontrolled myocarditis or symptomatic congestive heart failure Class II-IV (New York Heart Association ,NYHA), symptomatic or uncontrolled arrhythmia, QTc interval \> 480 ms, or personal or family history of...
- Uncontrolled hypertension with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg measured on 2 follow-up visits despite adequate standard treatment;
- Current gastrointestinal tract (muscle-derived tube from the oral cavity to the anus, including oral cavity, pharynx, esophagus, stomach, duodenum, jejunum, ileum, cecum, appendix, colon, rectum, and anus) or...
- Significant malnutrition, such as malnutrition requiring parenteral nutrition;
- Spinal cord compression that has not been radically cured by surgery and/or radiotherapy;
- Ascites, pleural effusion, or pericardial effusion that is symptomatic and requires intervention prior to the first dose of study intervention (participants who do not require treatment or who recover steadily without...
- With a history of pneumonia requiring corticosteroid treatment, or a history of clinically significant lung diseases (such as interstitial lung disease, non-infectious pneumonitis, or uncontrolled lung diseases such as...
- Any history of arterial thromboembolic events within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina, cerebrovascular stroke, or transient ischemic attack;
- Esophageal or gastric varices requiring immediate intervention (e.g., ligature or sclerotherapy) or at high risk of bleeding according to the opinion of the investigator or a gastroenterologist or hepatologist...
- Any history of life-threatening hemorrhage or hemorrhage requiring blood transfusion, endoscopy, or surgery within 3 months prior to the first dose of the investigational product ;
- Unhealed gastrointestinal obstruction, perforation, or fistula. At risk of gastrointestinal obstruction or perforation (including but not limited to: acute diverticulitis, abdominal abscess, etc.), history of extensive...
- History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases;
- History of allogeneic organ transplantation or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation within 3 months prior to the first dose of the investigational drug, except...
- History of other malignancy within 2 years before the first dose of study drug(s), with the following exceptions:
- Malignancy (other than in situ) treated with curative therapy with no known active disease present for ≥ 2 years prior to the first dose of study drug and at low risk of recurrence according to the physician's opinion;
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of residual or recurrent disease;
- Adequately treated carcinoma in situ without evidence of residual or recurrent disease;
- Prostate intraepithelial neoplasia without evidence of prostate cancer;
- Adequately treated urothelial papillary non-invasive carcinoma.
- Presence of any indwelling tubes or drains (such as percutaneous nephrostomy tubes, indwelling Foley catheters, biliary drainage tubes, or peritoneal/pericardial catheters); Note: Thoracic catheters or dedicated central...
- Other acute or chronic diseases or laboratory abnormalities, which may increase the risk of participating in the study or receiving the investigational product, interfere with the interpretation of study results, and...
- Neurological, mental, or social conditions that affect the compliance with trial requirements, significantly increase the risk of AEs, or affect the participants' signing of written informed consent (IC);
- Females who are pregnant, have a positive pregnancy test result, or are breastfeeding;
- Not fit to participate in this study at the discretion of the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.