TYRA-300 for Bladder Cancer

(SURF301 Trial)

Recruiting at 20 trial locations

Overseen By Grace Indyk

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Tyra Biosciences, Inc

Disqualifiers: Uncontrolled cardiovascular disease, Brain metastases, Gastrointestinal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

310 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Doug Warner

Principal Investigator

Tyra Biosciences, Inc

Eligibility Criteria

This trial is for adults with advanced solid tumors, including bladder cancer, that have run out of standard treatment options. They must be in relatively good health (ECOG ≤1) and have a specific FGFR3 gene alteration. Children over 12 can join Phase 2 if they're mostly healthy (KPS >70). Pregnant or breastfeeding individuals and those planning to conceive are excluded.

Inclusion Criteria

I am 12 or older with a certain level of physical ability and have at least one measurable tumor.

Exclusion Criteria

Your blood has too much phosphorus, even after trying to fix it with medicine.

I have an eye condition that could worsen with treatment.

I do not have any uncontrolled heart conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Participants receive TYRA-300 in 28-day cycles starting at 10 mg daily to determine the optimal and maximum tolerated dose

Varies based on dose escalation

Regular visits for dose monitoring

Phase 1 Dose Expansion

Participants receive TYRA-300 in 28-day cycles at doses determined during dose escalation

Varies based on dose expansion

Regular visits for safety and tolerability assessment

Phase 2

Participants receive TYRA-300 in 28-day cycles to evaluate preliminary antitumor activity

Varies based on treatment response

Regular visits for antitumor activity assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TYRA-300

Trial Overview TYRA-300 is being tested for safety and its ability to shrink tumors in patients with certain genetic changes in their cancer cells. The study will also look at how the body processes the drug. It's aimed at people whose cancers haven't responded to other treatments.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

TYRA-300 taken once or twice daily by mouth in 28-day cycles at doses determined during Phase 1.

Group II: Phase 1 Part B - dose expansion Experimental Treatment 1 Intervention

TYRA-300 taken once or twice daily by mouth in 28-day cycles.

Group III: Phase 1 Part A - dose escalation Experimental Treatment 1 Intervention

TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily.

Who Is Running the Clinical Trial?

Tyra Biosciences, Inc

Lead Sponsor

Trials

4

Recruited

500+