Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Melanoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Lymphosarcoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Immunomodulating Agents

Spartalizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Single agent arm. NIZ985 is administered as a single agent (subjects may be treated with the NIZ985-Spartalizumab combination after their first disease re-evaluation)

Combination arm. NIZ985 and Spartalizumab combination is administered starting at Cycle 1 Day 1 in dose escalation. NIZ985 and tislelizumab combination is administered starting at Cycle 1 Day 1 in dose expansion.

NIZ985

The purpose of this phase I/Ib study was to determine the safety profile of NIZ985 (new formulation), and if it could be safely combined with spartalizumab or tislelizumab and to determine the appropriate dose and schedule for further study. Moreover, the study characterized the pharmacokinetic profiles of NIZ985 as a single agent and in combination with spartalizumab or tislelizumab and identified preliminary anti-tumor activity.

This was a phase I/Ib, open-label, global, multi-center study of subcutaneously administered NIZ985 alone and in combination with a PD-1 inhibitor in patients with advanced solid tumors and lymphoma who had progressed after obtaining a previous response to anti-PD-1/ CPI therapy at any time prior to enrollment. Previous response was defined as a radiographic complete response (CR) or a partial response (PR). Patients with stable disease (SD) lasting ≥ 6 months could also be included if the most recent regimen included CPI. The study consisted of two parts, dose escalation and dose expansion. Two separate arms were examined during the escalation portion: 1) evaluation of NIZ985 as a single agent. Spartalizumab could be added at the time of the first disease re-evaluation and 2) administration of NIZ985 and spartalizumab as a combination starting from C1D1. In dose expansion, NIZ985 was administered in combination with tislelizumab.

A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab

A Phase I/Ib Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL-15/sIL-15Rα)) in Combination With Spartalizumab in Patients With Check Point Inhibitor (CPI) Relapsed Advanced Solid Tumors and Lymphoma

Incidence of DLTs in Cycle 1 (28 days) in escalation and expansion

AEs and SAEs including changes in laboratory parameters, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs for all patients from escalation and expansion

Number of dose interruptions and dose reductions of NIZ985, spartalizumab and tislelizumab.

Dose intensity as a ratio of cumulative dose received during duration of exposure over duration of exposure for NIZ985, spartalizumab and tislelizumab.

Measurement of serum concentrations of NIZ985, spartalizumab, and tislelizumab

Measurement of serum antidrug antibodies (ADA) to NIZ985, spartalizumab, and tislelizumab at baseline and on treatment

Novartis Pharmaceuticals

Digestive System Diseases

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Stomach Neoplasms

Esophageal Neoplasms

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Communicable Diseases

Vulvar Neoplasms

Abdominal Neoplasms

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Microsatellite Instability

Gastrointestinal Neoplasms

Epstein-Barr Virus Infections

Carcinoma, Basal Cell

Virus Diseases

Papillomavirus Infections

Nasopharyngeal Carcinoma

Genital Neoplasms, Female

Urogenital Neoplasms

Digestive System Neoplasms

Carcinoma, Merkel Cell

Vulvar Diseases

Neoplasms, Glandular and Epithelial

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Genital Diseases, Female

Stomach Cancer

Esophageal Cancer

Biliary Tract Cancer

Small Cell Lung Cancer

Vulvar Cancer

Merkel Cell Carcinoma

Small Intestine Cancer

Pharmaceutical Solutions

Antibodies

Antibodies, Bispecific

Immunoglobulins

Dose Escalation; Intervention: Drug: STAR0602

Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602

STAR0602

Ke Liu, MD, PhD

Guru Sonpavde, MD

Marijo Billusic, MD

Erica Redmond

James Gulley, MD, PhD

Ryan Sullivan, MD

Claire Friedman, MD

Kai He, MD

Lillian Siu, MD

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

Complete response (CR) and partial response (PR)

Marengo Therapeutics, Inc.

Lymphoma, Non-Hodgkin

Interleukin-12

Patients with relapsed/refractory advanced or metastatic solid tumors

WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen

WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved

WTX-330

Study Director

Clinical Trials Nurse Navigation

Suzanne Scott

Study Coordinator

Anne Younger

Aparna Parikh

Kim Benczkowski (Brosius)

Patrick Rethwisch

Julie Urban

Cynthia Deleon

A first-in-human, Phase 1, open-label, multicenter study of WTX-330 administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma.

This is a first-in-human, Phase 1, open-label, multicenter study to evaluate the safety, tolerability and preliminary efficacy of WTX-330, a conditionally-activated IL-12 prodrug, when administered as a monotherapy to patients with advanced or metastatic solid tumors or non-Hodgkin lymphoma. Dose escalation will be conducted in patients with advanced and/or metastatic solid tumors who are refractory to all standard of care therapies. Dose expansion will be conducted in two arms: Arm A will enroll patients with indications for which a checkpoint inhibitor (CPI) is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1 treatment regimen, and Arm B will enroll patients with tumor types for which CPI therapy is not indicated/approved.

WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

A Phase 1 (First-In-Human [FIH]), Multi-Site, Dose Escalation and Expansion Study of WTX-330 in Adult Patients With Advanced or Metastatic Solid Tumors or Lymphoma

Werewolf Therapeutics, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab	NCT04261439	In Escalation: ... In Expansion: M...	NIZ985 Spartalizumab Tislelizumab	18 Years -	Novartis
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors	NCT05592626	Advanced Solid ... Genital Neoplas... Urogenital Neop... Lung Neoplasm Neoplasms by Si... Papillomavirus ... Epstein-Barr Vi... Carcinoma Neoplasms Vulvar Neoplasm... Vulvar Diseases Abdominal Neopl...	STAR0602	18 Years -	Marengo Therapeutics, Inc.
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab	NCT04261439	In Escalation: ... In Expansion: M...	NIZ985 Spartalizumab Tislelizumab	18 Years -	Novartis
A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab	NCT04261439	In Escalation: ... In Expansion: M...	NIZ985 Spartalizumab Tislelizumab	18 Years -	Novartis
WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma	NCT05678998	Advanced or Met... Non-Hodgkin Lym...	WTX-330	18 Years -	Werewolf Therapeutics, Inc.

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