Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Status and phase

Not yet enrolling

Phase 1

Conditions

Solid Tumors

Treatments

Drug: IBI3020

Study type

Interventional

Funder types

Industry

Identifiers

NCT06946446

CIBI3020A101

Details and patient eligibility

About

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.

Enrollment

285 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.