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Evaluating KFA115 alone and with pembrolizumab for advanced cancers

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

Phase 1 Interventional Novartis · NCT05544929

This study is testing a new treatment called KFA115, both alone and with another drug called pembrolizumab, to see if it’s safe and effective for people with advanced cancers.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionssacituzumab, pembrolizumab, chemotherapy
Locations17 sites (Boston, Massachusetts and 16 other locations)
Trial IDNCT05544929 on ClinicalTrials.gov

What this trial studies

This phase I, open-label, multi-center study aims to assess the safety and tolerability of KFA115, both as a standalone treatment and in combination with pembrolizumab, for patients with select advanced cancers. The study will involve a dose escalation phase to determine the maximum tolerated dose (MTD) and recommended dose (RD), followed by dose expansion phases to evaluate preliminary anti-tumor activity and further safety assessments. Patients will be monitored for their response to treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced non-small cell lung cancer, renal cell carcinoma, or cutaneous melanoma who have previously received anti-PD(L)1 therapy and experienced disease progression.

Not a fit: Patients who have not received prior anti-PD(L)1 therapy or those with certain types of cancer not included in the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that have not responded to existing therapies.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Boston, Massachusetts and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungCutaneous MelanomaCarcinoma, Renal CellCarcinoma, Ovarian EpithelialNasopharyngeal CarcinomaCarcinoma, ThymicAnal CancerMesothelioma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.