AFM24-101 is a first in human Phase 1/2a open-label, non-randomized, multi-center, multiple
ascending dose escalation/expansion study evaluating AFM24 as monotherapy in patients with
advanced solid malignancies whose disease has progressed after treatment with previous
anticancer therapies.
There will be two parts to this study: a dose escalation phase (1) and a dose expansion phase
(2a).
The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD) and
establish the recommended Phase 2a dose (RP2D).
The dose escalation phase will be followed by the dose expansion phase once the MTD/RP2D of
AFM24 monotherapy has been determined. The dose expansion phase of the study using the
MTD/P2D is intended to collect preliminary evidence of efficacy and to further confirm the
safety of AFM24 as a monotherapy. The expansion phase will have 4 arms based on tumor type of
metastatic colorectal cancer and non-small cell lung cancer.
AFM24 is a tetravalent bispecific (anti-human EGFR x anti-human CD16A) innate immune cell
engaging recombinant antibody construct being developed to target EGFR-expressing solid
tumors . and has been designed to specifically utilize the cytotoxic potential of the innate
immune system, in particular natural killer cells and macrophages for the specific and
efficient elimination of EGFR-positive cancer cells.
Inclusion Criteria:
- Histologically or cytologically confirmed advanced or metastatic solid malignancies
that are known to express EGFR, or in which EGFR is thought to be a relevant
therapeutic target, including but not limiting to: colorectal, lung, gastric,
esophageal, pancreatic, head and neck, breast, ovarian, cervical, urothelial, and
renal cancers, and Glioblastoma multiforme.
- Previously treated with one or more lines of anticancer therapy and have documented
disease progression during or after their most recent line of anticancer therapy. In
addition, either there is no further SOC therapy for the patient or the remaining SOC
therapies are deemed not appropriate for the patient by the Investigator.
- Adequate organ function
- Patients must have at least one tumor site that is accessible to biopsy
- Phase 2a only: Measurable disease per RECIST v1.1
Exclusion Criteria:
- Treatment with systemic anticancer therapy within 4 weeks (6 weeks if therapy was
mitomycin C and/or nitrosoureas), or within 5 half-lives of the agent if half-life is
known and it is shorter, before first dose of study drug. Anticancer therapies include
cytotoxic chemotherapy, targeted inhibitors, and immunotherapies, but do not include
hormonal therapy or radiotherapy.
- Radiation therapy within 2 weeks before 1st dose of study drug or unresolved toxicity
from previous radiotherapy.
- History of any other malignancy known to be active, with the exception of completely
removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, DCIS,
early stage prostate cancer that has been adequately treated, and other cancers from
which the patient has been disease free for 3 years or longer.
- currently participating in a study and receiving study therapy, or participated in a
study of an investigational agent and received study therapy or used an
investigational device within 4 weeks of the first dose of study treatment.
