PBI-410 for Advanced Cancer

Recruiting at 12 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pyramid Biosciences

Must not be taking: Trop-2 ADCs

Disqualifiers: Pregnancy, Brain metastases, Lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

280 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 1/2, first in human (FIH), open-label, multicenter study of BHV-1510 monotherapy and in Combination with Cemiplimab in participants with previously treated, advanced solid tumors.

Will I have to stop taking my current medications?

The trial requires that you stop any standard cancer therapy or experimental therapy at least 3 weeks before starting the trial, or 2 weeks for bone-only radiation therapy. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Research Team

Chief Medical Officer

Principal Investigator

Biohaven Pharmaceuticals, Inc.

Eligibility Criteria

This trial is for adults (18+) with advanced solid tumors that can't be surgically removed or cured and have failed standard treatments. They should have acceptable liver function, no serious blood disorders, and a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory.

Inclusion Criteria

I am fully active or can carry out light work.

Measurable disease (per RECIST 1.1)

My blood, kidney, liver, and clotting tests are within normal ranges.

Exclusion Criteria

I have a serious eye condition affecting my cornea.

I have not had major surgery in the last 6 weeks.

I have a history of or currently have interstitial lung disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Investigation of the safety and tolerability of BHV-1510 given in monotherapy and in combination with cemiplimab to identify recommended doses for expansion and the maximum-tolerated dose

Approximately 15 months

Phase 2 Dose Expansion

Investigation of the preliminary efficacy of BHV-1510 in signal-finding expansion cohorts

Estimated as an average of 47 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PBI-410

Trial Overview The study tests PBI-410 on participants with previously treated advanced solid tumors. It's an open-label trial, meaning both the researchers and participants know what treatment is being given, to evaluate its safety and effectiveness.

Participant Groups

Group I: BHV-1510 in combination with Cemiplimab dose escalation Experimental Treatment 2 Interventions

Group II: BHV-1510 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Pyramid Biosciences

Lead Sponsor

Trials

8

Recruited

450+

Biohaven Therapeutics Ltd.

Lead Sponsor

Trials

13

Recruited

4,800+