Treatment with IBI3020 for patients with late-stage solid tumors

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

This study is testing a new treatment called IBI3020 to see if it is safe and what the best dose is for people with late-stage solid tumors who haven't had success with other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 285 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. (Industry-sponsored)
• Locations: 9 sites (Pheonix, Arizona and 8 other locations)
• Trial ID: NCT06963281 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of IBI3020 in participants with late-stage solid tumors. It aims to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RP2D) of the treatment. Participants will be closely monitored for any adverse effects and overall response to the therapy. The study includes patients who have previously undergone standard therapies and have shown disease progression or unacceptable side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable, locally advanced or metastatic solid tumors that have progressed after standard therapies.

Not a fit: Patients with resectable tumors or those who have not yet received standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with late-stage solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar treatments in late-stage solid tumors, indicating potential for success in this approach.

Eligibility criteria

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 which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;
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 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:

1. Previous treatment with CEACAM5-targeted therapy;
2. Prior anti-cancer therapy within the wash-out period;
3. Received live vaccines within 4 weeks or cancer vaccine within 3 months;
4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;
5. 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;
6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;
7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds;
8. Known symptomatic central nervous system (CNS) metastases;
9. Uncontrolled diseases or conditions;
10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;
11. History of thromboembolic event within 6 months;
12. Under neurological, psychiatric or social condition;
13. Women who are pregnant, have positive results in pregnancy test or are lactating;
14. Not eligible to participate in this study at the discretion of the investigator;
15. Participating in any other interventional clinical research.

Where this trial is running

Pheonix, Arizona and 8 other locations

• Mayo Clinic - Arizona — Pheonix, Arizona, United States (Recruiting)
• Mayo Clinic - Florida — Jacksonville, Florida, United States (Recruiting)
• Mayo Clinic - Rochester — Rochester, Minnesota, United States (Recruiting)
• Montefiore Cancer Center — New York, New York, United States (Recruiting)
• NEXT Houston — Houston, Texas, United States (Recruiting)
• NEXT Dallas — Irving, Texas, 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)

Study contacts

• Study coordinator: Serena Dong

Conditions Solid Tumors