KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

Novartis

Status and phase: Terminated; Early Phase 1

Conditions: Solid Tumors

Treatments: Drug: NIR178; Drug: KAZ954; Drug: PDR001; Drug: NZV930

Study type: Interventional

Funder types: Industry

Identifiers

NCT04237649

CKAZ954A12101

2019-002841-39 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.

Full description

The purpose of this trial was to explore the clinical utility of several therapies in patients with advanced cancer.

This is a multi-center, open-label Phase I/Ib study. The study consisted of a dose escalation part and a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178.

The dose escalation part estimated the MTD and/or RD and tested different dosing schedules. The dose escalation arm KAZ954 + NZV930 was not opened.

The dose expansion part of the study was planned to use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer. The dose expansion part of the study was not started.

Enrollment: 77 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with metastatic and/or advanced malignancies not amenable to curative treatment by surgery.

Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during the study.

ECOG Performance Status of <2.

Exclusion criteria

Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require concurrent treatment - including surgery, radiation and/or corticosteroids.

History of severe hypersensitivity reaction to any ingredient of study drug(s) and other mAbs and/or their excipients.

Impaired cardiac function HIV Known history of tuberculosis Systemic chronic steroid therapy

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

77 participants in 4 patient groups

Arm A

Experimental group

Description:

KAZ954

Treatment:

Drug: KAZ954

Arm B

Experimental group

Description:

KAZ954 + PDR001

Treatment:

Drug: PDR001

Drug: KAZ954

Arm C

Experimental group

Description:

KAZ954 + NIR178

Treatment:

Drug: KAZ954

Drug: NIR178

Arm D

Experimental group

Description:

KAZ954 + NZV930

Treatment:

Drug: NZV930

Drug: KAZ954