PBI-410 for Advanced Cancer

Recruiting at 31 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

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PBI-410 (also known as BHV-1510) for individuals with advanced solid tumors who have not found success with other therapies. The trial examines PBI-410 both alone and in combination with another drug, Cemiplimab, to assess their effectiveness and safety. Suitable candidates have solid tumors that cannot be surgically removed and have not responded to standard treatments. The goal is to discover better options for these challenging cancers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatment PBI-410, also known as BHV-1510, has been safe in early animal tests. These studies found the treatment stable and non-harmful. Early human tests also support these findings, indicating that PBI-410 is generally well-tolerated. When combined with Cemiplimab, a type of immunotherapy, the treatment continues to show promising results without major safety issues reported so far. While these results are encouraging, the treatment is still under study to fully understand its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for advanced cancer, which often include chemotherapy and targeted therapies, PBI-410 offers a novel approach. Researchers are excited about these treatments because BHV-1510, the active component, works differently. In one arm, BHV-1510 is combined with Cemiplimab, a PD-1 inhibitor, potentially enhancing the immune response against cancer cells. The monotherapy arm explores BHV-1510's ability to directly target cancer cells, possibly offering a more precise treatment option. This innovative mechanism of action could lead to better outcomes and fewer side effects compared to existing therapies.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research has shown that BHV-1510, formerly known as PBI-410, shows early signs of effectiveness against advanced solid tumors. BHV-1510 is an antibody-drug conjugate, delivering cancer-fighting agents directly to cancer cells. In this trial, some participants will receive BHV-1510 as monotherapy, and early results suggest it works well independently. Other participants will receive BHV-1510 combined with Cemiplimab, a treatment that helps the immune system fight cancer, potentially enhancing its effectiveness. This two-part approach aims to attack the cancer directly while boosting the body's natural defenses. Initial study data are promising, indicating potential benefits for patients with advanced cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

Biohaven Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06384807?intr=PBI-410&rank=1

A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in ... 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 ...

2. ir.biohaven.com ir.biohaven.com/news-releases/news-release-details/biohaven-presents-oncology-program-updates-and-preliminary

Press Release Details BHV-1510, a highly differentiated Trop2 ADC incorporating the proprietary TopoIx payload, demonstrates early clinical activity and favorable ...

3. jcto.weill.cornell.edu jcto.weill.cornell.edu/open_clinical_trials/a-phase-12-first-in-human-dose-escalation-and-dose-expansion-study-of-bhv-1510-previously-pbi-410-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-participants-with-advanced-solid-tumors

A Phase 1/2, First in Human, Dose Escalation and ... This study is being done to evaluate the safety and potential effectiveness of BHV-1510 alone and BHV-1510 in combination with cemiplimab in participants ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06107

A Phase 1/2 Study of BHV-1510 (Previously PBI-410) in ... 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 ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=9b68b4e1-f1b8-4566-8ffc-0a3b618fe1f9

BHV-1510 / GeneQuantum Healthcare, Biohaven The Phase 1/2 study of BHV-1510 is a multicenter, open-label study in subjects with select advanced or metastatic epithelial cell tumors.

6. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/7168/738911/Abstract-7168-PBI-410-GQ1010-A-novel-Trop-2?searchresult=1

Abstract 7168: PBI-410 (GQ1010), A novel Trop-2-targeted ... This study included comprehensive preclinical evaluations that demonstrated a favorable safety and TK profile and potential for broader ...

7. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/1549/721413/Abstract-1549-Preclinical-characterization-of

Abstract 1549: Preclinical characterization of GQ1010, a next ... Here we report that GQ1010 demonstrates superior anti-tumor activities against benchmark Trop2 ADCs while maintaining excellent safety profiles.