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

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiohaven Therapeutics Ltd.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged ≥18 years.

Unresectable, incurable, locally advanced or metastatic epithelial-origin solid tumor that is refractory to standard therapies, or has no approved standard therapies, or no approved standard therapies at its current treatment stage. If applicable to the tumor type, participants must have received platinum-based chemotherapy, standard of care immunotherapy, and standard of care targeted therapies.

Measurable disease (per RECIST 1.1).

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

Disqualifiers

Women who are pregnant or lactating.

Clinically significant intercurrent disease.

Has symptomatic brain metastases or has had any radiation or surgery for brain metastases within 4 weeks of C1D1.

Has clinically significant corneal disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BHV-1510

    Drug

    BHV-1510 will be administered on Day 1 every 3 weeks

  • Cemiplimab

    Drug

    cemiplimab (350mg) will be administered as an IV infusion on Day 1 every 3 weeks

  • BHV-1510

    Drug

    BHV-1510 will be administered on Day 1 every 2 weeks

  • BHV-1510

    Drug

    BHV-1510 will be administered on Day 1 and Day 8 every 3 weeks

  • Cemiplimab

    Drug

    cemiplimab (350mg) will be administered as an IV infusion on Day 1 and Day 8 every 3 weeks

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: BHV-1510 Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: BHV-1510 in combination with Cemiplimab dose escalationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Number of patients with adverse events (AEs)

Description: Incidence and severity of AEs, serious adverse events (SAEs) and dose limiting toxicities (DLTs). Severity of AEs will be assessed according to the NCI CTCAE v5.0. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.

Time frame
Through study completion, estimated as an average of 47 months
2

Phase 1: Recommended doses or schedules for expansion (RDEs) and maximum tolerated dose (MTD)

Based on tolerability and preliminary antitumor activity. This applies to both the BHV-1510 monotherapy arm and BHV-1510 in combination with Cemiplimab arm.

Time frame
Approximately 15 months
3

Phase 2: Objective Response Rate (ORR) for BHV-1510 for monotherapy and in combination with cemiplimab

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.

Time frame
Through study completion, estimated as an average of 47 months
4

Phase 2: Number of patients with AEs for BHV-1510 for monotherapy and in combination with cemiplimab

Incidence and severity of AEs, SAEs and DLTs. Severity of AEs will be assessed according to the NCI CTCAE v5.0

Time frame
Through study completion, estimated as an average of 47 months

Secondary outcomes

1

Phase 1 and 2: Maximum Plasma Concentration (Cmax) of BHV-1510, total antibody and payload (BHC-0080269)

Time frame
Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
2

Phase 1 and 2: Area Under the Concentration versus time Curve from the end of infusion to the last measurable concentration (AUClast) of BHV-1510, total antibody and payload

Time frame
Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3
3

Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) of BHV-1510, total antibody and payload

Time frame
Up to 8 timepoints, but not exceeding, 22 days in Cycle 1
4

Phase 1 and 2: Area under the concentration versus time curve over the dosing interval (AUCtau) of BHV-1510, total antibody and payload

Time frame
Up to 8 timepoints, but not exceeding, 22 days in Cycles 1 and 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biohaven Therapeutics Ltd.

Lead sponsor

Source ClinicalTrials.gov
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