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Recruiting NCT06963281

Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors

Phase I Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI3020.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Overview

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.

Interventions

  • Drug IBI3020
    Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection

Primary outcome measures

  • Numbers of subjects with adverse events [Time frame: Up to 3 years]
  • Number of subjects with clinically significant changes in physical examination results [Time frame: Up to 3 years]
  • Number of subjects with clinically significant changes in electrocardiogram [Time frame: Up to 3 years]
  • Number of subjects with clinically significant changes in vital signs [Time frame: Up to 3 years]
  • Dose limiting toxicities (DLTs) [Time frame: Up to 21 days]
  • objective response rate (ORR) [Time frame: Up to 3 years]
  • Number of subjects with clinically significant changes in laboratory parameters [Time frame: Up to 3 years]
Secondary outcome measures (12)
  • 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]
  • objective response rate (ORR) [Time frame: Up to 3 years]
  • duration of response (DoR) [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]
  • disease control rate (DCR) [Time frame: Up to 3 years]

Eligibility criteria

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 which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;
  • 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 use at 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;
  • Prior anti-cancer therapy within the wash-out period;
  • Received live vaccines within 4 weeks or cancer vaccine within 3 months;
  • Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
  • 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;
  • Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
  • Known symptomatic central nervous system (CNS) metastases;
  • Uncontrolled diseases or conditions;
  • History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
  • History of thromboembolic event within 6 months;
  • Under neurological, psychiatric or social condition;
  • 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;
  • Participating in any other interventional clinical research.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Mayo Clinic - Arizona — Pheonix
  • Mayo Clinic - Florida — Jacksonville
  • Mayo Clinic - Rochester — Rochester
  • Montefiore Cancer Center — New York
  • NEXT Houston — Houston
  • NEXT Dallas — Irving
China · 3 centers
  • The sixth affiliated hospital, Sun Yat-sen University — Guangzhou
  • Shandong Cancer Hospital — Jinan
  • Shanxi Cancer Hospital — Taiyuan

Identifiers

NCT: NCT06963281 · "CIBI3020A101"

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗