This trial is shared by:

Have you been diagnosed with cancer and screened for changes in a gene called FGFR2 and/or FGFR3?

If so, then you may be eligible to participate in an actively enrolling clinical research study.

Check Eligibility

When speaking with your doctor refer to the National Clinical Trial (NCT) identifier number: NCT05242822

About the Study

Kinnate Biopharma Inc. (the study sponsor) is evaluating the efficacy and safety of KIN-3248 (the study drug) in adults with advanced cancer (solid tumors) who have an FGFR2 and/or FGFR3 mutation. FGFR mutations are found in bladder cancers, cholangiocarcinoma, and other cancers. To find out if you have an FGFR mutation, talk with your doctor about ordering biomarker testing or tumor profiling.

This study (also called a clinical trial) will include adults from around the world with advanced solid tumors who have FGFR2 and/or FGFR3 mutations. For this study, participants will take the study drug every day orally (by mouth) and will visit their study site regularly. The sponsor will provide travel support and arrangements to the study site for the participant and one caregiver during participation in the study.

Visit the National Institutes of Health (NIH) clinical trial website for detailed information by using the National Clinical Trial (NCT) identifier number to search for this study: NCT05242822 Home - ClinicalTrials.gov

About the Study Drug

KIN-3248 (study drug) is a type of cancer drug known as a targeted therapy. The purpose of targeted therapies is to aim at specific parts of cancer cells, such as genes that have changed (mutated), to stop the cancer cells from growing or spreading. For some cancers, targeted therapies may work better than other available treatments.

KN-4802 Study Details

This study will be conducted in 2 parts. The main goals in each part are:

Part A

To learn more about the safety and tolerability of the study drug (whether the participants have any medical issues during treatment and, if so, what types of medical issues and how severe they are). The results of Part A will help determine the dose or doses participants take in Part B.

Part B

To learn how each participant’s cancer responds to the study drug.

See Eligibility Criteria

Estimated Enrollment

120

participants

Estimated Enrollment

Phase 1/1b

Eligibility Criteria

Participants must:

  • Be at least 18 years old (or above the age of majority in local jurisdictions).
  • Have a cancer diagnosis of advanced cancerous tumors, such as cholangiocarcinoma (ICC or bile duct cancer), advanced bladder cancer (urothelial cancer), or any other type of advanced cancerous tumors.
  • Had a genomic or molecular test on your tumor and the results show FGFR2 and/or FGFR3 gene mutations.
  • Cancer is no longer responding to standard anti-cancer treatment, or there is not standard treatment available.
  • Be able to take medications by mouth.
  • Be able to attend study visits and complete study assessments.

Participants must not:

  • Currently enrolled in another clinical trial.
  • Have certain medical conditions such as heart problems or infections that cannot be controlled by medications.
  • Be breastfeeding or lactating, or pregnant.

See if you are eligible

Check Eligibility

What Will Happen in This Study

If you are interested in participating this study, you will need to visit a clinical study site. A doctor will explain the study to you. If you agree to participate, the doctors and study staff will perform an evaluation to make sure you are eligible.

If you decide to participate this study, you will receive the study drug until:

  • you choose to leave the study,
  • you start a new treatment for your cancer,
  • your cancer progresses,
  • your doctor thinks it would be in your best interest to stop treatment with the study drug, or
  • the study ends.

Full details about the study, visits, and examinations will be discussed with you before you decide to participate in the study.

What Can You Do Next?

If you are interested in learning more about this study, take the following steps:

Take the prescreen questionnaire on this website
Select a study site
Share contact information with study site coordinator
Make contact and respond to study site coordinator that you selected
Share the NCT Identifier Number with your doctor

NCT identifier number: NCT05242822

Travel Support

Kinnate Biopharma will cover travel expenses related to the study visits for the participant and one caregiver at select sites that participate in our travel support program. Examples of expenses:

  • Airfare
  • Hotel
  • Meals
  • Parking fees
  • Childcare, eldercare, and pet care

Additional information on travel support will be provided by the site staff should you decide to participate.

Check Eligibility

Where You Can Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
Status
Johns Hopkins Univeristy , Baltimore, MD, 21287, United States
Recruiting
Mayo Clinic Jacksonville, Jacksonville, Florida, 32224, United States
Recruiting
UCSD, Moores Cancer Center, La Jolla, California, 92037, United States
Recruiting

See if you are eligible

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