BHV-1530 for Cancer

Recruiting at 3 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biohaven Therapeutics Ltd.

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

Compensation: Varies

Number of Visits: Unknown

95 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1, first in human (FIH), open-label, multicenter study of BHV-1530 in adult participants with advanced or metastatic solid tumors.

Eligibility Criteria

Adults over 18 with advanced solid tumors that have relapsed or are resistant to treatment can join this trial. They must be in good physical condition, not pregnant, willing to use contraception, and have no serious heart issues or infections. People with certain drug treatments or health conditions that could affect the study's results cannot participate.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My liver is working well.

My cancer has returned or didn't respond to treatment and has spread.

Exclusion Criteria

I have been treated with specific drugs before.

I have a heart condition or recently had a heart event.

Abnormal corrected QT interval

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of BHV-1530 to determine the maximum tolerated dose

Estimated 48 months

Dose Expansion

Participants receive the determined dose to further evaluate safety and efficacy

Estimated 48 months

Dose Confirmation

Participants receive the recommended dose to confirm safety and efficacy for later phase trials

Estimated 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BHV-1530

Trial Overview BHV-1530 (AMB302) is being tested for the first time in humans to see if it's safe and effective against advanced solid tumors. This Phase 1 trial is open-label and multicenter, meaning both researchers and participants know what treatment is given.

Participant Groups

Group I: BHV-1530 Monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+