Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors

NCT07589205 | Recruiting Phase 1

• 1 other identifier: CIBI3028A101
• Study Type: interventional
• Target: 493
• Locations: 1 country
• Sites: 1

Brief Summary

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; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Non-small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (12)

• 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

  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

  Up to 3 years

• Number of subjects with clinically significant changes in laboratory parameters

  Clinically significant abnormal laboratory parameters findings reported by the investigator.

  Up to 3 years

• Number of subjects with clinically significant changes in electrocardiogram

  Clinically significant abnormal electrocardiogram findings reported by the investigator.

  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

  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.

  Up to 3 years

• Number of AEs（adverse events） leading to dose interruption

  AEs（adverse events） leading to dose interruption reported by the investigator

  Up to 3 years

• Number of AEs leading to dose delay

  AEs leading to dose delay reported by the investigator

  Up to 3 years

• Number of AEs leading to dose reduction

  AEs leading to dose reduction reported by the investigator

  Up to 3 years

• Number of AEs leading to permanent discontinuation

  AEs leading to permanent discontinuation reported by the investigator

  Up to 3 years

• Dose limiting toxicities (DLTs)

  Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.

  Up to 21 days

• Objective response rate (ORR) in dose expansion

  Objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.

  Up to 3 years

Secondary Outcomes (14)

• Area under the curve (AUC)

  Up to 3 years

• Maximum concentration (Cmax)

  Up to 3 years

• Time to maximum concentration (Tmax)

  Up to 3 years

• Clearance (CL)

  Up to 3 years

• Apparent volume of distribution (V)

  Up to 3 years

Study Arms (1)

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.

Drug: Drug: IBI3028

Interventions

Drug: IBI3028 DRUG

Recombinant anti-EGFR（Epidermal growth factor receptor） and c-Met antibodies-dual-payload conjugate for injection

Drug: IBI3028

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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), 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).

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Central Study Contacts

Yuxiao Xue

CONTACT

(+86)18697486628; yuxiao.xue@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 15, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)