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

NCT06963281 | Recruiting Phase 1 FDA Drug

• 1 other identifier: "CIBI3020A101"
• Study Type: interventional
• Target: 285
• Locations: 2 countries
• Sites: 9

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (7)

• 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

• 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 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

• Dose limiting toxicities (DLTs)

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

  Up to 21 days

• objective response rate (ORR)

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

  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

Secondary Outcomes (13)

• 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)

IBI3020

EXPERIMENTAL

Drug: IBI3020

Interventions

IBI3020 DRUG

Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection

IBI3020

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.: lead
• Fortvita Biologics (USA)Inc.: collaborator

Study Sites (9)

Mayo Clinic - Arizona

Pheonix, Arizona, 85054, United States

RECRUITING

Mayo Clinic - Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Montefiore Cancer Center

New York, New York, 10461, United States

RECRUITING

NEXT Houston

Houston, Texas, 77054, United States

RECRUITING

NEXT Dallas

Irving, Texas, 75039, United States

RECRUITING

The sixth affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

RECRUITING

Central Study Contacts

Serena Dong

CONTACT

051269566088; suhua.dong@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 30, 2025
• First Posted: May 8, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (6); CN (3)