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NCT05544929 | RECRUITING | Carcinoma, Non-Small-Cell Lung

A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
Sponsor:

Novartis Pharmaceuticals

Brief Summary:

The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.

Condition or disease

Carcinoma, Non-Small-Cell Lung

Cutaneous Melanoma

Carcinoma, Renal Cell

Carcinoma, Ovarian Epithelial

Nasopharyngeal Carcinoma

Carcinoma, Thymic

Anal Cancer

Mesothelioma

Esophagogastric Cancer

High Microsatellite Instability Colorectal Carcinoma

Squamous Cell Carcinoma of Head and Neck

Triple Negative Breast Neoplasms

Intervention/treatment

KFA115

pembrolizumab

Phase

PHASE1

Detailed Description:

This is a phase I, open-label, multi-center study of KFA115 as a single agent and in combination with pembrolizumab. The study consists of a dose escalation part, followed by dose expansion part(s) for single-agent KFA115 and KFA115 in combination with pembrolizumab. The escalation parts will characterize safety and tolerability. After the determination of the maximum tolerated dose (MTD) / recommended dose (RD), the dose expansion parts will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at MTD/RD.

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
Actual Study Start Date : 2022-10-26
Estimated Primary Completion Date : 2027-09-01
Estimated Study Completion Date : 2027-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Non-small cell lung cancer with historic PD-L1 ≥ 1%, as determined locally using a clinically accepted assay. Patients must have experienced benefit from previous anti-PD(L)1-containing therapy for at least 4 months based on investigator-assessed disease stability or response prior to developing documented disease progression. Patients must have also received prior platinum-based chemotherapy, either in combination or in sequence with anti-PD-(L)1, unless patient was ineligible to receive such treatment.
  • * Renal cell carcinoma, clear cell histology, previously treated with anti-PD(L)1-containing therapy and a VEGF targeted therapy as monotherapy or in combination. Patients should have documented disease progression following anti-PD(L)1-containing therapy.
  • * Cutaneous melanoma, previously treated with anti-PD(L)1-containing therapy. Patients should have documented disease progression following anti-PD(L)1-containing therapy. Patients with BRAF V600-mutant melanoma must have also received prior therapy with a BRAF V600 inhibitor, with or without a MEK inhibitor.
  • * Ovarian cancer, high-grade serous histology, naïve to anti-PD(L)1 therapy, must have received one prior systemic therapy in platinum-resistant setting.
  • * Nasopharyngeal carcinoma, non-keratinizing locally advanced recurrent or metastatic. Depending on the study arm, patients may be naïve to anti-PD(L)1 therapy, or previously treated with platinum-based chemotherapy with or without anti-PD-(L)1.
  • * Locally advanced unresectable or metastatic triple negative breast cancer, ovarian cancer (high-grade serous histology), anal cancer (squamous), MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC.
  • * Locally advanced unresectable or metastatic anal cancer (squamous), thymic carcinoma, MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC, all naïve to anti-PD(L)1 therapy and for whom anti PD(L)1 therapy is not available.
  • * Triple negative breast cancer with historic PD-L1 CPS ≥ 1%, must have received at least one line of chemotherapy. In addition, these patients must have previously received sacituzumab govitecan, and in the case of a BRCA mutation a PARP inhibitor, if these treatments are locally approved and accessible to the patient.
Exclusion Criteria
  • * Impaired cardiac function or clinically significant cardiac disease.
  • * Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study.
  • * History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
  • * Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur may be considered. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
  • * Any evidence of interstitial lung disease (ILD) or pneumonitis, or a prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
  • * Patients who discontinued prior anti-PD-(L)1 therapy due to an anti-PD-(L)1-related toxicity (applicable to the KFA115 in combination with pembrolizumab treatment arms).
  • * Patients with symptomatic peripheral neuropathy limiting instrumental activities of daily living.
  • Other protocol-defined inclusion/exclusion criteria may apply
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers

Location Details

NCT05544929

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Massachusetts General Hospital .

Boston, Massachusetts, United States, 02114

RECRUITING

United States, New York

NYU School of Medicine

New York, New York, United States, 10015

RECRUITING

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Tennessee

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

Canada, Ontario

Novartis Investigative Site

Toronto, Ontario, Canada, M5G 2M9

RECRUITING

China, Guangdong

Novartis Investigative Site

Guangzhou, Guangdong, China, 510080

RECRUITING

France,

Novartis Investigative Site

Lyon, France, 69373

RECRUITING

Germany,

Novartis Investigative Site

Dresden, Germany, 01307

RECRUITING

Germany,

Novartis Investigative Site

Essen, Germany, 45147

RECRUITING

Hong Kong,

Novartis Investigative Site

Hong Kong, Hong Kong, 999077

RECRUITING

Italy, MI

Novartis Investigative Site

Milano, MI, Italy, 20133

RECRUITING

Japan, Tokyo

Novartis Investigative Site

c or library, Tokyo, Japan, 104 0045

RECRUITING

Korea, Republic of,

Novartis Investigative Site

Seoul, Korea, Republic of, 03080

RECRUITING

Singapore,

Novartis Investigative Site

Singapore, Singapore, 119074

RECRUITING

Spain, Catalonia

Novartis Investigative Site

Barcelona, Catalonia, Spain, 08035

RECRUITING

Taiwan,

Novartis Investigative Site

Taipei, Taiwan, 10002