Study of safety and efficacy of KFA115 alone or in combination with tislelizumab in patients with select advanced cancers

JRCT ID: jRCT2031230410

Registered date:17/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Advanced or metastatic disease
• Date of first enrollment: 01/11/2023
• Target sample size: 10
• Countries of recruitment: Canada,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Italy,Japan,Republic of Korea,Japan,Singapore,Japan,Spain,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Dose escalation part A, Dose expansion part A: KFA115 single agent
Dose escalation part B, Dose expansion part B: KFA115 single agent (1 cycle) and then KFA115 + tislelizumab
Dose expansion C: KFA115 + tislelizumab

Outcome(s)

• Primary Outcome: safey, tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
-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.
-Ovarian cancer, high-grade serous histology, naive to anti-PD(L)1 therapy, no more than 3 prior lines of systemic therapy for recurrent/metastatic disease.
-Nasopharyngeal carcinoma, non-keratinizing locally advanced recurrent or metastatic, naive to anti-PD(L)1 therapy.
-Locally advanced unresectable or metastatic anal cancer (squamous), thymic carcinoma, MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC, all naive to anti-PD(L)1 therapy.
-Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during therapy on the study, if medically feasible. Exceptions may be considered after documented discussion with Novartis. Patients with archival tumor tissue obtained =< 6 months prior to study treatment initiation do not need to undergo a new tumor biopsy at screening, if the patient has not received any anti cancer therapy since the biopsy was taken, and if adequate tissue is available.
-Patients must have body weight > 36 kg.

Exclude 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 tislelizumab treatment arms).
-Patients with symptomatic peripheral neuropathy limiting instrumental activities of daily living.

Related Information

• Primary Sponsor: Yonemura Masataka
• Secondary ID(s): NCT05544929