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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: IBI3020

• Study Type: Interventional
• Enrollment (Estimated): 285
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Serena Dong; Phone Number: 051269566088; Email: suhua.dong@innoventbio.com

Study Locations

• China
  • Guangzhou, China, Guangdong
    • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Contact: Yanhong Deng
    • Contact: Yanhong Deng; Phone Number: 020-38254000; Email: 13925106525@163.com
  • Shandong
    • Jinan, Shandong, China
      • Shandong Cancer Hospital
      • Contact: Yuping Sun
      • Contact: Jinming Yu; Phone Number: 0531-87984777; Email: sdyujinming@126.com, 13370582181@163.com
      • Contact: Jinming Sun
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Cancer Hospital
      • Contact: Jie Wang
      • Contact: Jie Wang; Phone Number: 0351-4881611; Email: zlhuxi@163.com
• United States
  • Arizona
    • Pheonix, Arizona, United States, 85054
      • Mayo Clinic - Arizona
      • Contact: Dr. Mitesh Borad
      • Contact: Dr. Mitesh Borad; Phone Number: 480-301-8000; Email: Borad.Mitesh@mayo.edu
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic - Florida
      • Contact: Dr. Yanyan Lou; Phone Number: (480) 342-2000; Email: Borad.Mitesh@mayo.edu
      • Contact: Dr. Yanyan Lou
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
      • Contact: Dr. Hao Xie; Phone Number: (507) 512-1667; Email: Xie.Hao@mayo.edu
      • Contact: Dr. Hao Xie
  • New York
    • New york, New York, United States, 10461
      • Montefiore Cancer Center
      • Contact: Dr. Fernand Bteich; Phone Number: (718) 405-8124; Email: fbteich@montefiore.org
      • Contact: Dr. Fernand Bteich
  • Texas
    • Houston, Texas, United States, 77054
      • NEXT Houston
      • Contact: Jennifer Segar; Phone Number: 832-384-7900; Email: jsegar@nextoncology.com
      • Contact: Jennifer Segar
    • Irving, Texas, United States, 75039
      • NEXT Dallas
      • Contact: Shiraj Sen
      • Contact: Shiraj Sen; Phone Number: 972-893-8800; Email: ssen@nextoncology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must satisfy all of the following criteria to be enrolled into the study:

1. 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;
2. Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;
3. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors:
4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
6. Minimum life expectancy of 12 weeks;
7. Adequate bone marrow and organ function confirmed at screening period,
8. 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:

1. Previous treatment with CEACAM5-targeted therapy, or previous treatment with an ADC with a TOPO1 payload AND an ADC with an MMAE payload;
2. Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
3. Prior anti-cancer therapy:
4. 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;
5. 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;
6. 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
7. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients (refer to Investigator's Brochure);
8. 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.;
9. Known symptomatic central nervous system (CNS) metastases
10. Uncontrolled diseases or conditions including:
11. 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;
12. 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.;
13. 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;
14. Women who are pregnant, have positive results in pregnancy test or are lactating;
15. Not eligible to participate in this study at the discretion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI3020	Drug: IBI3020; Recombinant anti-CEACAM5 monoclonal antibody-Vedotin/ Camptothecin Derivative conjugate for Injection (R & D code: IBI3020 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
anti-drug antibody (ADA)	Incidence and characterization of anti-drug antibody (ADA).	Up to 3 years
objective response rate (ORR)	objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.	Up to 3 years
duration of response (DoR)	duration of response (DoR) as evaluated per the RECIST v1.1 criteria.	Up to 3 years
time to response (TTR)	time to response (TTR) as evaluated per the RECIST v1.1 criteria.	Up to 3 years
progression free survival (PFS)	as evaluated per the RECIST v1.1 criteria.	Up to 3 years
area under the curve (AUC)	area under the curve (AUC) of single and multiple doses of IBI3020	Up to 3 years
maximum concentration (Cmax)	maximum concentration (Cmax) of single and multiple doses of IBI3020	Up to 3 years
time to maximum concentration (Tmax)	time to maximum concentration (Tmax) of single and multiple doses of IBI3020	Up to 3 years
clearance (CL)	clearance (CL) of single and multiple doses of IBI3020	Up to 3 years
apparent volume of distribution (V)	apparent volume of distribution (V) of single and multiple doses of IBI3020	Up to 3 years
half-life (t1/2)	half-life (t1/2) of IBI3009 to the last administration of IBI3020	Up to 3 years
disease control rate (DCR)	disease control rate (DCR)as evaluated per the RECIST v1.1 criteria.	Up to 3 years
overall survival (OS)	From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months	OS is defined as the time from the date of first dose of study drug until the date of death from any cause.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI3020A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No