- |||||||||| SNK01 / NKMAX
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases: Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers (clinicaltrials.gov) - Mar 1, 2024 P1/2, N=11, Terminated, N=121 --> 11 | Trial completion date: Nov 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.
- |||||||||| AFM24 / Affimed
Enrollment closed, Enrollment change, Trial primary completion date, Metastases: Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - Aug 23, 2023 P1/2, N=85, Active, not recruiting, Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01. Recruiting --> Active, not recruiting | N=155 --> 85 | Trial primary completion date: Apr 2024 --> Jul 2023
- |||||||||| SNK01 / NKMAX
Enrollment closed, Combination therapy, Metastases: Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers (clinicaltrials.gov) - Aug 1, 2023 P1/2, N=121, Active, not recruiting, N=105 --> 148 Recruiting --> Active, not recruiting
- |||||||||| AFM24 / Affimed
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov) - Oct 3, 2022 P1/2, N=105, Recruiting, Clinical and correlative science from the escalation phase of the study supports further investigation of AFM24 anti-tumor activity in EGFR-expressing tumor-specific cohorts. Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Sep 2024
- |||||||||| AFM24 / Affimed
Trial completion date, Trial primary completion date, Metastases: Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - Oct 3, 2022 P1/2, N=155, Recruiting, Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Jan 2023 --> Sep 2024 Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Sep 2022 --> Apr 2024
- |||||||||| AFM24 / Affimed, Tecentriq (atezolizumab) / Roche
AFM24 in combination with atezolizumab in patients with advanced EGFR-expressing solid tumors: Phase 1/2a study design and rationale. (Available On Demand; 325b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1732; P1/2 The Phase 2a study will then establish the overall response rate (as per RECIST v1.1) and safety of combination therapy in patients with advanced/ metastatic, or treatment refractory gastric, esophagogastric, hepatocellular, hepatobiliary, pancreatic, or non-small cell lung cancer. For both phases, secondary endpoints include treatment-emergent adverse events, serious adverse events, pharmacokinetics, pharmacodynamics, and immunogenicity.
- |||||||||| AFM24 / Affimed
A phase 1/2a open label, multicenter study to assess the safety, tolerability, pharmacokinetics, and efficacy of AFM24 in patients with advanced solid cancers: Study design and rationale. (Available On Demand; 325a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1731; P1/2 These comprise patients with clear cell renal cell carcinoma (ccRCC), KRAS wild-type colorectal cancer (KRASwt CRC), and EGFR-mutant non-small cell lung cancer (EGFRmut NSCLC). Secondary endpoints include treatment-emergent adverse events, serious adverse events, PK, PD, and immunogenicity.
- |||||||||| AFM24 / Affimed
Trial primary completion date, Metastases: Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - Apr 15, 2022 P1/2, N=155, Recruiting, Secondary endpoints include treatment-emergent adverse events, serious adverse events, PK, PD, and immunogenicity. Trial primary completion date: Apr 2022 --> Sep 2022
- |||||||||| AFM24 / Affimed
Preclinical, Journal: Preclinical evaluation of AFM24, a novel CD16A-specific innate immune cell engager targeting EGFR-positive tumors. (Pubmed Central) - Jan 26, 2022 A transient elevation of interleukin-6 levels was detected at all dose levels, 2-4 hours post-dose, which returned to baseline levels after 24 hours. These results emphasize the promise of bispecific innate cell engagers as an alternative cancer therapy and demonstrate the potential for AFM24 to effectively target tumors expressing varying levels of EGFR, regardless of their mutational status.Abbreviations: ADA: antidrug antibody; ADCC: antibody-dependent cell-mediated cytotoxicity; ADCP: antibody-dependent cellular phagocytosis; AUC: area under the curve; CAR: chimeric-antigen receptor; CD: Cluster of differentiation; CRC :colorectal cancer; ECD: extracellular domain; EGF: epidermal growth factorEGFR epidermal growth factor receptor; ELISA: enzyme-linked immunosorbent assay; FACS: fluorescence-activated cell sorting; Fc: fragment, crystallizableFv variable fragment; HNSCC: head and neck squamous carcinomaIL interleukinm; Ab monoclonal antibody; MOA: mechanism of action; NK :natural killer; NSCLC: non-small cell lung cancer; PBMC: peripheral blood mononuclear cell; PBS: phosphate-buffered saline; PD: pharmacodynamic; ROCK: redirected optimized cell killing; RSV: respiratory syncytial virus; SABC: specific antibody binding capacity; SD: standard deviation; TAM: tumor-associated macrophage; TKI: tyrosine kinase inhibitor; WT: wildtype.
- |||||||||| AFM24 / Affimed
Enrollment open, Combination therapy, Metastases: Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov) - Dec 3, 2021 P1/2, N=105, Recruiting, These results emphasize the promise of bispecific innate cell engagers as an alternative cancer therapy and demonstrate the potential for AFM24 to effectively target tumors expressing varying levels of EGFR, regardless of their mutational status.Abbreviations: ADA: antidrug antibody; ADCC: antibody-dependent cell-mediated cytotoxicity; ADCP: antibody-dependent cellular phagocytosis; AUC: area under the curve; CAR: chimeric-antigen receptor; CD: Cluster of differentiation; CRC :colorectal cancer; ECD: extracellular domain; EGF: epidermal growth factorEGFR epidermal growth factor receptor; ELISA: enzyme-linked immunosorbent assay; FACS: fluorescence-activated cell sorting; Fc: fragment, crystallizableFv variable fragment; HNSCC: head and neck squamous carcinomaIL interleukinm; Ab monoclonal antibody; MOA: mechanism of action; NK :natural killer; NSCLC: non-small cell lung cancer; PBMC: peripheral blood mononuclear cell; PBS: phosphate-buffered saline; PD: pharmacodynamic; ROCK: redirected optimized cell killing; RSV: respiratory syncytial virus; SABC: specific antibody binding capacity; SD: standard deviation; TAM: tumor-associated macrophage; TKI: tyrosine kinase inhibitor; WT: wildtype. Not yet recruiting --> Recruiting
- |||||||||| AFM24 / Affimed
Tetravalent, bispecific innate cell engager AFM24 enhances macrophage mediated tumor cell phagocytosis (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_1161; In addition, due to its novel mechanism of action, AFM24 may overcome limitations of existing EGFR-targeting agents, such as dose limiting toxicity, and/or intrinsic or acquired resistance of the tumor. Consequently, AFM24 may be a potential future treatment option for a wide spectrum of patients including those that do not respond or are resistant to current EGFR-directed therapies that inhibit the signaling pathway.
- |||||||||| AFM24 / Affimed
Enrollment change, Trial completion date, Metastases: Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - Sep 27, 2021 P1/2, N=155, Recruiting, Consequently, AFM24 may be a potential future treatment option for a wide spectrum of patients including those that do not respond or are resistant to current EGFR-directed therapies that inhibit the signaling pathway. N=70 --> 155 | Trial completion date: Mar 2023 --> Mar 2024
- |||||||||| AFM24 / Affimed, Erbitux (cetuximab) / Eli Lilly, EMD Serono
AFM24, a bispecific EGFR/CD16A innate cell engager with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3266; In contrast, EGFR-targeting mAbs (e.g. cetuximab) exhibited severe toxicities particularly in skin in toxicology studies when investigated with a similar dosing schedule.Due to its potent activation of innate immunity and its beneficial safety/tolerability profile, AFM24 has the potential to become a novel treatment option for patients suffering from EGFR-expressing cancers and to overcome limitations of available EGFR-targeted therapies such as resistance and/or associated toxicities. AFM24 has cleared the IND and clinical investigations are planned in patients with cancers known to express EGFR.
- |||||||||| AFM24 / Affimed
Enrollment open, Metastases: Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - Feb 19, 2020 P1/2, N=70, Recruiting, AFM24 has cleared the IND and clinical investigations are planned in patients with cancers known to express EGFR. Not yet recruiting --> Recruiting
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