Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT06946446
- Lead Sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Brief Summary
The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RP2D) of IBI3020.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 285
Participants must satisfy all of the following criteria to be enrolled into the study:
- Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
- Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors:
- At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Minimum life expectancy of 12 weeks;
- Adequate bone marrow and organ function confirmed at screening period,
- Participants, both male and female, who are not of childbearing potential or who agree to useat least 1 highly effective method of contraception during the study
Participants who meet any of the following criteria will be disqualified from entering the study:
- Previous treatment with CEACAM5-targeted therapy, or previous treatment with an ADC with a TOPO1 payload AND an ADC with an MMAE payload;
- Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
- Prior anti-cancer therapy:
- Received live vaccines within 4 weeks or cancer vaccine within 3 months prior to the first dose of the study drug or plan on receiving any live vaccine during the study;
- Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives prior to the first dose of the study drug, whichever is shorter;
- Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0
- Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients (refer to Investigator's Brochure);
- Undergone major surgery (craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.;
- Known symptomatic central nervous system (CNS) metastases
- Uncontrolled diseases or conditions including:
- History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases (e.g., interstitial lung disease, non-infectious pneumonia, or uncontrolled lung disease such as pulmonary fibrosis, severe radiation pneumonitis and acute lung injury) or who are suspected to have these diseases by imaging at screening period;
- History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug, including myocardial infarction, unstable angina pectoris, cerebrovascular stroke or transient ischemic attack, etc.;
- Under neurological, psychiatric or social condition that affects compliance with study requirements, significantly increases the risk of adverse events, or affects participants' ability to provide written informed consent;
- Women who are pregnant, have positive results in pregnancy test or are lactating;
- Not eligible to participate in this study at the discretion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description IBI3020 IBI3020 -
- Primary Outcome Measures
Name Time Method Number of subjects with clinically significant changes in electrocardiogram Up to 3 years Clinically significant abnormal electrocardiogram findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs Up to 3 years Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure
Dose limiting toxicities (DLTs) Up to 21 days Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
objective response rate (ORR) Up to 3 years objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
Number of subjects with clinically significant changes in laboratory parameters Up to 3 years Clinically significant abnormal laboratory parameters findings reported by the investigator.
Numbers of subjects with adverse events 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
Number of subjects with clinically significant changes in physical examination results Up to 3 years Clinically significant abnormal physical examination findings reported by the investigator.
- Secondary Outcome Measures
Name Time Method area under the curve (AUC) Up to 3 years area under the curve (AUC) of single and multiple doses of IBI3020
maximum concentration (Cmax) Up to 3 years maximum concentration (Cmax) of single and multiple doses of IBI3020
time to maximum concentration (Tmax) Up to 3 years time to maximum concentration (Tmax) of single and multiple doses of IBI3020
clearance (CL) Up to 3 years clearance (CL) of single and multiple doses of IBI3020
apparent volume of distribution (V) Up to 3 years apparent volume of distribution (V) of single and multiple doses of IBI3020
half-life (t1/2) Up to 3 years half-life (t1/2) of IBI3009 to the last administration of IBI3020
anti-drug antibody (ADA) Up to 3 years Incidence and characterization of anti-drug antibody (ADA).
objective response rate (ORR) Up to 3 years objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
duration of response (DoR) Up to 3 years duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
time to response (TTR) Up to 3 years time to response (TTR) as evaluated per the RECIST v1.1 criteria.
progression free survival (PFS) Up to 3 years as evaluated per the RECIST v1.1 criteria.
disease control rate (DCR) Up to 3 years disease control rate (DCR)as evaluated per the RECIST v1.1 criteria.
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. From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months
Trial Locations
- Locations (9)
Mayo Clinic - Arizona
🇺🇸Pheonix, Arizona, United States
Mayo Clinic - Florida
🇺🇸Jacksonville, Florida, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Montefiore Cancer Center
🇺🇸New york, New York, United States
NEXT Houston
🇺🇸Houston, Texas, United States
NEXT Dallas
🇺🇸Irving, Texas, United States
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The sixth affiliated hospital, Sun Yat-sen University
🇨🇳Guangzhou, China