18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: The Number of Subjects With Dose Limiting Toxicities (DLTs) During Cycle 1Primary· During Cycle 1 (up to 28 days)
The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0. DLT is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to underlying disease, disease progression, inter-current illness, or concomitant medications, that occurs ≤28 days following the first dose of AFM24 (Cycle 1).
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
0
Phase 1- 40 mg Cohort 2
1
Phase 1- 80 mg Cohort 3
0
Phase 1- 160 mg Cohort 4
0
Phase 1- 320 mg Cohort 5
0
Phase 1- 480 mg Cohort 6
0
Phase 1- 720 mg Cohort 7
0
Phase 2a: Overall Response Rate (Complete Response [CR] + Partial Response [PR])Primary· Up to approximately 16 weeks.
Overall response as defined by achieving confirmed CR and/or PR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial or complete response needs to be confirmed with repeated assessment at least 4 weeks after the initial assessment.
Group
Value
95% CI
Phase 2- CRC 480 mg Cohort A
0
Phase 2- ccRCC 480 mg Cohort B
0
Phase 2- NSCLC 480 mg Cohort C
2
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs)Secondary· From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Adverse Events (AEs) will be summarized with patient counts by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs) and Preferred Terms (PTs).
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
2
Phase 1- 40 mg Cohort 2
6
Phase 1- 80 mg Cohort 3
4
Phase 1- 160 mg Cohort 4
5
Phase 1- 320 mg Cohort 5
6
Phase 1- 480 mg Cohort 6
6
Phase 1- 720 mg Cohort 7
6
Phase 1: The Number of Subjects With Serious Adverse Events (SAEs)Secondary· From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Serious adverse Events (SAEs) will be summarized with patient counts by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs) and Preferred Terms (PTs).
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
2
Phase 1- 40 mg Cohort 2
3
Phase 1- 80 mg Cohort 3
2
Phase 1- 160 mg Cohort 4
2
Phase 1- 320 mg Cohort 5
4
Phase 1- 480 mg Cohort 6
3
Phase 1- 720 mg Cohort 7
2
Phase 1: Area Under the Concentration-time Curve From Time 0 to Time Tau (7 Days) of AFM24 in PlasmaSecondary· Pre-dose (2 hours maximum) and 15, 30, 45 min after start of infusion (SOI) and end of infusion (EOI) and 1, 4, 18, 24, 48, 144 hours after EOI on Cycle 1 Day 22.
Area under the concentration-time curve from time 0 to time tau (7 days) of AFM24 in plasma (AUC0-168)
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
53400
± 61700
Phase 1- 40 mg Cohort 2
549000
± 254000
Phase 1- 80 mg Cohort 3
1290000
± 395000
Phase 1- 160 mg Cohort 4
4940000
± 1370000
Phase 1- 320 mg Cohort 5
18100000
± 6120000
Phase 1- 480 mg Cohort 6
28700000
± 7620000
Phase 1- 720 mg Cohort 7
40200000
± 12000000
Phase 1: Maximum Plasma Concentration (Cmax) of AFM24Secondary· Pre-dose (2 hours maximum) and 15, 30, 45 min after start of infusion (SOI) and end of infusion (EOI) and 1, 4, 18, 24, 48, 144 hours after EOI on Cycle 1 Day 1 and on pre-dose (2 hours maximum) Cycle 1 Day 8.
Maximum measured concentration (Cmax) of AFM24 in plasma
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
3290
± 2860
Phase 1- 40 mg Cohort 2
13200
± 3100
Phase 1- 80 mg Cohort 3
29200
± 6620
Phase 1- 160 mg Cohort 4
60900
± 17600
Phase 1- 320 mg Cohort 5
204000
± 55600
Phase 1- 480 mg Cohort 6
298000
± 71100
Phase 1- 720 mg Cohort 7
354000
± 104000
Phase 1: Time of Maximum Observed Concentration (Tmax) of AFM24Secondary· Pre-dose (2 hours maximum) and 15, 30, 45 min after start of infusion (SOI) and end of infusion (EOI) and 1, 4, 18, 24, 48, 144 hours after EOI on Cycle 1 Day 22.
First time to maximum observed concentration of AFM24 sampled during a dosing interval.
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
1.84
± 1.19
Phase 1- 40 mg Cohort 2
3.43
± 1.97
Phase 1- 80 mg Cohort 3
5.63
± 1.71
Phase 1- 160 mg Cohort 4
5.64
± 1.30
Phase 1- 320 mg Cohort 5
7.18
± 0.564
Phase 1- 480 mg Cohort 6
7.52
± 1.38
Phase 1- 720 mg Cohort 7
5.21
± 0.280
Phase 1: Minimum Plasma Concentration (Cmin) of AFM24Secondary· Pre-dose (2 hours maximum) and 15, 30, 45 min after start of infusion (SOI) and end of infusion (EOI) and 1, 4, 18, 24, 48, 144 hours after EOI on Cycle 1 Day 1 and on pre-dose (2 hours maximum) Cycle 1 Day 22.
Minimum measured concentration (Cmin) of AFM24 in plasma
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
32.7
± 46.2
Phase 1- 40 mg Cohort 2
311
± 281
Phase 1- 80 mg Cohort 3
810
± 482
Phase 1- 160 mg Cohort 4
12000
± 3540
Phase 1- 320 mg Cohort 5
73800
± 40600
Phase 1- 480 mg Cohort 6
117000
± 49600
Phase 1- 720 mg Cohort 7
233000
± 113000
Phase 1: The Number of Subjects Who Developed Anti-drug Antibodies (ADAs) and Neutralizing ADAs During Treatment With AFM24Secondary· Pre-dose cycle 1 Day 1 and end of treatment, up to approximately 39 weeks.
The number of subjects who developed anti-drug antibodies (ADAs) at any time during the study.
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
1
Phase 1- 40 mg Cohort 2
4
Phase 1- 80 mg Cohort 3
2
Phase 1- 160 mg Cohort 4
3
Phase 1- 320 mg Cohort 5
1
Phase 1- 480 mg Cohort 6
0
Phase 1- 720 mg Cohort 7
1
Phase 1: Overall Response Rate (Complete Response (CR) + Partial Response (PR))Secondary· From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Overall response as defined by achieving confirmed CR and/or PR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial or complete response needs to be confirmed with repeated assessment at least 4 weeks after the initial assessment by local reader.
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
0
Phase 1- 40 mg Cohort 2
0
Phase 1- 80 mg Cohort 3
0
Phase 1- 160 mg Cohort 4
0
Phase 1- 320 mg Cohort 5
0
Phase 1- 480 mg Cohort 6
0
Phase 1- 720 mg Cohort 7
0
Phase 1: Disease Control Rate (Complete Response (CR) + Partial Response (PR) +Stable Disease (SD))Secondary· From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Disease control as defined by achieving CR and/or PR and/or SD assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Group
Value
95% CI
Phase 1- 14 mg Cohort 1
0
Phase 1- 40 mg Cohort 2
1
Phase 1- 80 mg Cohort 3
0
Phase 1- 160 mg Cohort 4
0
Phase 1- 320 mg Cohort 5
0
Phase 1- 480 mg Cohort 6
2
Phase 1- 720 mg Cohort 7
1
Phase 2a: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs)Secondary· From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Adverse Events (AEs) will be summarized with patient counts by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs) and Preferred Terms (PTs).
Group
Value
95% CI
Phase 2- CRC 480 mg Cohort A
19
Phase 2- ccRCC 480 mg Cohort B
8
Phase 2- NSCLC 480 mg Cohort C
23
Adverse events — posted to ClinicalTrials.gov
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1- 14 mg Cohort 1
Serious: 2/2 (100%)
Deaths: 1/2
Phase 1- 40 mg Cohort 2
Serious: 3/6 (50%)
Deaths: 6/6
Phase 1- 80 mg Cohort 3
Serious: 2/4 (50%)
Deaths: 4/4
Phase 1- 160 mg Cohort 4
Serious: 2/5 (40%)
Deaths: 3/5
Phase 1- 320 mg Cohort 5
Serious: 4/6 (67%)
Deaths: 4/6
Phase 1- 480 mg Cohort 6
Serious: 3/6 (50%)
Deaths: 4/6
Phase 1- 720 mg Cohort 7
Serious: 2/6 (33%)
Deaths: 6/6
Phase 2- CRC 480 mg Cohort A
Serious: 8/19 (42%)
Deaths: 14/19
Phase 2- ccRCC 480 mg Cohort B
Serious: 6/8 (75%)
Deaths: 6/8
Phase 2- NSCLC 480 mg Cohort C
Serious: 8/23 (35%)
Deaths: 7/23
Serious adverse events (46 terms)
Reaction
System
Phase 1- 14 mg Cohort 1
Phase 1- 40 mg Cohort 2
Phase 1- 80 mg Cohort 3
Phase 1- 160 mg Cohort 4
Phase 1- 320 mg Cohort 5
Phase 1- 480 mg Cohort 6
Phase 1- 720 mg Cohort 7
Phase 2- CRC 480 mg Cohort A
Phase 2- ccRCC 480 mg Coho…
Phase 2- NSCLC 480 mg Coho…
Abdominal pain
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
Infusion related reaction
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
Sinus tachycardia
Cardiac disorders
—
—
—
—
—
—
—
—
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
Fatigue
General disorders
—
—
—
—
—
—
—
—
—
—
Non-cardiac chest pain
General disorders
—
—
—
—
—
—
—
—
—
—
Pain
General disorders
—
—
—
—
—
—
—
—
—
—
Cholangitis
Hepatobiliary disorders
—
—
—
—
—
—
—
—
—
—
COVID-19
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Cholangitis infective
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
—
—
—
—
—
—
—
Failure to thrive
Metabolism and nutrition disorders
—
—
—
—
—
—
—
—
—
—
Back pain
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
—
—
—
—
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
—
—
—
Haematuria
Renal and urinary disorders
—
—
—
—
—
—
—
—
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
Productive cough
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
Tachypnoea
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
Anaemia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
Blindness
Eye disorders
—
—
—
—
—
—
—
—
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
—
—
—
—
—
—
—
—
Other adverse events (155 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07300943 — Study in Advanced Solid Tumor Patients
· Phase 1, PHASE2
· recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors
· Phase 1
· recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity
· Phase 1, PHASE2
· recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
· Phase 1
· recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli
· Phase 1
· recruiting
Other Affimed GmbH trials
Trials by the same sponsor.
NCT05883449 — Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL
· Phase 2
· terminated
NCT05817058 — First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
· Phase 1
· terminated
NCT05109442 — Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers
· Phase 1, PHASE2
· terminated
NCT04101331 — Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Affimed GmbH
Last refreshed: 17 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04259450.