Treatment with IBI3020 for patients with late-stage solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic - Arizona
  Phoenix, 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

Study contacts

• Study coordinator: Fortvita Biologics CT.gov Call Center
• Email: ct.govNotifications@fortvitabio.com
• Phone: 650-370-0985

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BA1203 in advanced solid tumors: safety and early signs of activity

  This early-phase trial tests BA1203 in adults with advanced solid tumors to see if it is safe, tolerable, how the drug behaves in the body, and whether it shows any early signs of effectiveness.

  Recruiting Phase 1 Shandong Boan Biotechnology Co., Ltd · Beijing · NCT07876609

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• REC-7735 for PIK3CA-H1047R-mutant solid tumors

  This study tests REC-7735 in people with unresectable, locally advanced, or metastatic solid tumors that carry the PIK3CA-H1047R mutation.

  Recruiting at 3 sites Phase 1/2 Recursion Pharmaceuticals Inc. · Grand Rapids, Michigan and 2 other locations · NCT07819136

• Preferences of physicians and patients for cell therapies in advanced solid tumors

  This study tests how doctors and patients weigh the benefits, risks, and burdens of CAR-T, TIL, TCR-T, and NK cell therapies in advanced solid cancers.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07813000

• HP007 monotherapy for relapsed or advanced solid tumors

  This study tests HP007 as a standalone treatment in adults with hard-to-treat solid tumors to see if it is safe and tolerable and to look for early signs of activity.

  Recruiting Phase 1 Parr Biotechnology (Hebei) Co., Ltd. · Changchun, Jilin · NCT07800936

• ONO-7429 in advanced or recurrent solid tumors

  This small early-phase study tests whether ONO-7429 is tolerable and safe in adults with unresectable advanced or recurrent solid tumors who have tried other treatments.

  Recruiting at 10 sites Phase 1 Ono Pharmaceutical Co., Ltd. · Kashiwa, Chiba and 9 other locations · NCT07787208

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.