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.
AFM24 is a tetravalent bispecific (anti-human EGFR x anti-human CD16A) innate immune cell
engaging recombinant antibody 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 expressing cancer cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04259450.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer CenterStatus: Active
Contact: Eric Scott Christenson
Phone: 410-955-8866
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 3 arms based on tumor
type.
- Renal cell carcinoma(clear cell), failing standard of care (SoC) that includes TKIs
and PD1 targeted therapy
- Non-small cell lung cancer (EGFR-mut), failing SoC TKIs
- Colorectal cancer, failing SOC chemotherapy, VEGF(R) and EGFR targeted antibodies
Lead OrganizationAffimed GmbH