Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Pembrolizumab

Interleukin-2

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)

In part 1 \& part 2

• LAVA-1207 will be administered via intravenous infusion.

LAVA-1207

Pembrolizumab will be administered via intravenous infusion

LAVA-1207 plus Pembrolizumab

Clinical Trials Administrator

Joel Picus, MD

Kelsey Egberts

David R. Wise, MD, PhD

Hannan Aslam

Umang Swami, MD, MS

Susan Sharry

Clinical Trials Management

This is a phase 1/2a, first-in-human study to evaluate Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer.

This trial is an open-label Phase 1 and 2a dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory mCRPC.

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer

A Phase 1/2a Open-label Trial to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207, a PSMA-targeting Bispecific γδ-T Cell Engager, Alone or With Low Dose Interleukin-2 or Pembrolizumab, in Patients With Therapy Refractory mCRPC

To evaluate the effect of study treatment on circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA)

Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events and grading for CRS

DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment.illness, or concomitant medications and is occurring during the first 28 days of treatment.

According to immune Response Evaluation Criteria in Solid Tumors (RECIST and iRECIST) in patients with measurable disease.

Area under the plasma concentration versus time curve (AUC) of LAVA-1207 will be assessed in all patients

Development of antibodies (anti-drug antibodies) to LAVA-1207 will be evaluated

Binding of LAVA-1207 to Vγ9Vδ2-T cells will be measured in whole blood

Merck Sharp & Dohme LLC

Lava Therapeutics

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphoid

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphatic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Analgesics, Non-Narcotic

Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection.

* Group A: LAVA-051
* Group B: LAVA-051 + low dose interleukin 2

Part 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study

In part 1 and part 2, LAVA-051 will be administered via intravenous (IV) infusion

LAVA-051

In Part 1 and Part 2, a low dose of interleukin 2 will be given via subcutaneous injection with LAVA-051 in a selected group of patients

Interleukin 2

A phase 1/2a, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).

An open-label, phase 1/2a dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML.

Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML

A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients With Relapsed or Refractory CLL, MM, or AML

Frequency, severity, and grading of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE) v5.0. CRS will be evaluated using the ASTCT.

A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment. These events will be classified according to the CTCAE v5.0; CRS will be evaluated according to the ASTCT consensus criteria

Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria

Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051

Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer	NCT05369000	Metastatic Cast...	LAVA-1207 LAVA-1207 plus ...	18 Years -	Lava Therapeutics
Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML	NCT04887259	Chronic Lymphoc... Multiple Myelom... Acute Myeloid L...	LAVA-051 Interleukin 2	18 Years -	Lava Therapeutics

Spots Global Cancer Trial Database for phase 2 safety