Solid TumorPhase 1NCT07589205
Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
A Phase 1 study testing Drug: IBI3028 in people with Solid Tumor and Colorectal Cancer, run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 1 site in China.
Trial summary
This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Colorectal Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Drug: IBI3028
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 30 Jun 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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;
Show all 14Show fewer
- 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), granulocyte-macrophage colony stimulating factor (GM-CSF), thrombopoietin (TPO), interleukin-11, or other leukocyte/platelet stimulating growth factors (including red blood cell and platelet transfusions) within at least 7 days before the first dose of the study drug;
- 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 liver metastases (≤ 5 × ULN if liver metastases are present); albumin ≥ 2.8 g/dL;
- 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 are allowed);
- 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 weeks prior to first dose, whichever occurs first, and continue until 7 months for females and 4 months for males after the last dose of study drug).
Who cannot join
- Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional 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 PD-1/PD-L1 therapy within 4 weeks prior to the first administration of study drug; Participants who have received treatment with small molecule targeted therapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of the study drug; Palliative radiation therapy within 2 weeks or radical radiation therapy within 4 weeks prior to the first dose of study drug; Participants who had received adoptive cell therapy within 8 weeks prior to the first administration of study intervention.
- 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, pigmentation, and other conditions with no safety implications per the Investigator's clinical judgement);
Show all 38Show fewer
- 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 product, or are expected to undergo major surgery during the study, or have severe unhealed wounds, ulcers, etc.;
- 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 investigator may be considered if: they have no metastases in the midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord; stable status for at least 4 weeks prior to the first dose of study drug (≤1.5 mg/day dexamethasone or equivalent and baseline anticonvulsants are allowed), and have no new or enlarging CNS metastases as clearly demonstrated by clinical evidence; Note : CNS lesions are not considered target lesions.
- 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 participate in the study under the premise of undetectable viral load, or well-controlled under antiretroviral therapy (defined as CD4+ T cell count ≥ 350 cells/μL and no history of AIDS-defining opportunistic infection within 12 months before the first dose);
- 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 detection);
- 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 congenital long/short QT syndrome;
- 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 endotracheal stent implantation;
- 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 intervention are eligible).
- 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 pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or suspected of having these diseases by imaging during the screening period;
- 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. Participants with evidence of portal hypertension (including imaging findings of hypersplenism) or a history of esophageal and gastric variceal bleeding must undergo endoscopic evaluation within 3 months prior to the first dose of the study drug;
- 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 bowel resection (segmental colectomy or extensive bowel resection accompanied with chronic diarrhea), active inflammatory bowel disease, or Grade ≥ 2 chronic diarrhea;
- 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 for corneal transplantation;
- 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 venous access catheters such as Port-A-Cath or Hickman catheters are allowed.
- 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 make the participant unsuitable for participating in the study based on the investigator's judgment;
- 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.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, 18622221120, haojihui@tjmuch.com
Yi Hu
About this study
Official title: A Phase 1, Multi-Center, Open-Label Study Evaluating IBI3028 Treatment in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
This is a phase 1 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
- Conditions
- Solid Tumor, Colorectal Cancer, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Head and Neck Squamous Cell Carcinoma
- Being tested
- Drug: IBI3028
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: IBI3028Drug
Recombinant anti-EGFR（Epidermal growth factor receptor） and c-Met antibodies-dual-payload conjugate for injection
| Study group | Role | What they receive |
|---|---|---|
| Drug: IBI3028 | Experimental | IBI3028 will be dosed until disease progression, toxicity intolerance, starting of new systemic anti-cancer treatment, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaching the maximum of 24 months, whichever occurs first. Receives: Drug: Drug: IBI3028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of subjects with adverse events
Defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 years
Numbers of subjects with serious adverse events
Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Measured: Up to 3 years
Number of subjects with clinically significant changes in laboratory parameters
Clinically significant abnormal laboratory parameters findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in electrocardiogram
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Measured: Up to 3 years
Number of subjects with clinically significant changes in vital signs
Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Measured: Up to 3 years
Number of subjects with clinically significant changes in physical examination results
Clinically significant abnormal physical examination findings reported by the investigator.
Measured: Up to 3 years
Number of AEs（adverse events） leading to dose interruption
AEs（adverse events） leading to dose interruption reported by the investigator
Measured: Up to 3 years
Number of AEs leading to dose reduction
AEs leading to dose reduction reported by the investigator
Measured: Up to 3 years
Number of AEs leading to permanent discontinuation
AEs leading to permanent discontinuation reported by the investigator
Measured: Up to 3 years
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Measured: Up to 21 days
Objective response rate (ORR) in dose expansion
Objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Measured: Up to 3 years
Secondary outcomes (14)
Area under the curve (AUC)
Area under the curve (AUC) of single and multiple doses of IBI3028
Measured: Up to 3 years
Maximum concentration (Cmax)
Maximum concentration (Cmax) of single and multiple doses of IBI3028
Measured: Up to 3 years
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) of single and multiple doses of IBI3028
Measured: Up to 3 years
Clearance (CL)
Clearance (CL) of single and multiple doses of IBI3028
Measured: Up to 3 years
Apparent volume of distribution (V)
apparent volume of distribution (V) of single and multiple doses of IBI3028
Measured: Up to 3 years
Half-life (t1/2)
Half-life (t1/2) of IBI3020 to the last administration of IBI3028
Measured: Up to 3 years
Anti-drug antibody (ADA)
Incidence and characterization of anti-drug antibody (ADA)
Measured: Up to 3 years
Neutralizing antibody (NAb)
Incidence and characterization of neutralizing antibody (NAb)
Measured: Up to 3 years
Objective response rate (ORR)
Objective response rate (ORR) as evaluated per the RECIST v1.1 criteria
Measured: Up to 3 years
Duration of response (DoR)
Duration of response (DoR) as evaluated per the RECIST v1.1 criteria
Measured: Up to 3 years
Disease control rate (DCR)
Disease control rate (DCR) as evaluated per the RECIST v1.1 criteria
Measured: Up to 3 years
Time to response (TTR)
Time to response (TTR) as evaluated per the RECIST v1.1 criteria
Measured: Up to 3 years
Progression-free survival (PFS)
progression-free survival (PFS) as evaluated per the RECIST v1.1 criteria
Measured: Up to 3 years
Overall survival (OS)
OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
Measured: 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 posted15 May 2026
- Study start31 Mar 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 493 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589205
- Sponsor's protocol ID
- CIBI3028A101
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-Center, Open-Label Study Evaluating IBI3028 Treatment in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07589205
- Acronym / sponsor ID
- CIBI3028A101
- Conditions
- Solid Tumor, Colorectal Cancer, Non-small Cell Lung Cancer, Pancreatic Ductal Adenocarcinoma, Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 493 participants (estimated)
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 May 2026 (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 multi-center, open-label study evaluating IBI3028 Treatment in participants with locally advanced, unresectable, or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: IBI3028 | Experimental | Drug: Drug: IBI3028IBI3028 will be dosed until disease progression, toxicity intolerance, starting of new systemic anti-cancer treatment, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or treatment duration reaching the maximum of 24 months, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (38 listed)
- Participation in any other interventional clinical study other than an observational (non-interventional) study or during the follow-up period of an interventional 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 PD-1/PD-L1 therapy within 4 weeks prior to the first administration of study drug; Participants who have received treatment with small molecule targeted therapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of the study drug; Palliative radiation therapy within 2 weeks or radical radiation therapy within 4 weeks prior to the first dose of study drug; Participants who had received adoptive cell therapy within 8 weeks prior to the first administration of study intervention.
- 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;
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 |
|---|---|---|
| Drug: IBI3028Recombinant anti-EGFR（Epidermal growth factor receptor） and c-Met antibodies-dual-payload conjugate for injection | Drug | Drug: IBI3028 |
Primary outcome
Numbers of subjects with adverse events
Time frame: Up to 3 years
Defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Numbers of subjects with serious adverse events
Time frame: Up to 3 years
Defined as any serious untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in laboratory parameters
Time frame: Up to 3 years
Clinically significant abnormal laboratory parameters findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram
Time frame: Up to 3 years
Clinically significant abnormal electrocardiogram findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs
Time frame: Up to 3 years
Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Number of subjects with clinically significant changes in physical examination results
Time frame: Up to 3 years
Clinically significant abnormal physical examination findings reported by the investigator.
Number of AEs（adverse events） leading to dose interruption
Time frame: Up to 3 years
AEs（adverse events） leading to dose interruption reported by the investigator
Number of AEs leading to dose reduction
Time frame: Up to 3 years
AEs leading to dose reduction reported by the investigator
Number of AEs leading to permanent discontinuation
Time frame: Up to 3 years
AEs leading to permanent discontinuation reported by the investigator
Dose limiting toxicities (DLTs)
Time frame: Up to 21 days
Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
Objective response rate (ORR) in dose expansion
Time frame: Up to 3 years
Objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
14 secondary outcomes
Area under the curve (AUC)
Time frame: Up to 3 years
Maximum concentration (Cmax)
Time frame: Up to 3 years
Time to maximum concentration (Tmax)
Time frame: Up to 3 years
Clearance (CL)
Time frame: Up to 3 years
Apparent volume of distribution (V)
Time frame: Up to 3 years
Half-life (t1/2)
Time frame: Up to 3 years
Anti-drug antibody (ADA)
Time frame: Up to 3 years
Neutralizing antibody (NAb)
Time frame: Up to 3 years
Objective response rate (ORR)
Time frame: Up to 3 years
Duration of response (DoR)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Time to response (TTR)
Time frame: Up to 3 years
Progression-free survival (PFS)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
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 23 Jul 2026.
Related trials for Solid Tumor
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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drug: IBI3028 in people with Solid Tumor and Colorectal Cancer, run by Innovent Biopharmaceutical Technology (Hangzhou) 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 14 inclusion and 38 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 23 Jul 2026. 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 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.
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 Shijie Liu ((+86)18701121959, shijie.liu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of subjects with adverse events (time frame: Up to 3 years). The study lists 11 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 23 Jul 2026.