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

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