BHV-1530 for Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Biohaven Therapeutics Ltd.

No Placebo Group

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.

Research Team

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.

I am 18 years old or older.

See 8 more

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

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Trial 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 (Virus Therapy)

Trial OverviewBHV-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

1Treatment groups

Experimental Treatment

Group I: BHV-1530 MonotherapyExperimental Treatment1 Intervention