Advanced Solid TumorPhase 1/2NCT04259450
Study to Assess AFM24 in Advanced Solid Cancers
A Phase 1/2 study testing 14 mg AFM24, 40 mg AFM24 and 80 mg AFM24 in people with Advanced Solid Tumor, run by Affimed GmbH at 13 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- 14 mg AFM24, 40 mg AFM24 and 80 mg AFM24
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 7 Apr 2020to 24 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adequate organ function
- Phase 1: Histologically or cytologically confirmed advanced or metastatic solid malignancies that are known to express EGFR
- Phase 1: Previously treated with ≥ 1 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.
- Phase 1: Patients must have at least one tumor site that is accessible to biopsy
- Phase 2a: Measurable disease per RECIST 1.1
- Phase 2a: Histologically confirmed advanced or metastatic EGFR+ malignancies for each expansion cohorts:
Show all 9Show fewer
- Colorectal Cancer (MSS), KRAS-wildtype: disease has progressed after ≥ 2 prior lines of therapy which must have included oxaliplatin, fluoropyrimidine, bevacizumab, and an anti-EGFR therapy
- ccRCC: disease has progressed after ≥ 2 prior lines of therapy which must have included a TKI and a checkpoint inhibitor
- metastatic NSCLC, EGFRmut: disease has progressed on/after after ≥ 1 prior lines of therapy for advanced disease including ≥ 1 prior TKI approved for EGFR mut NSCLC
Who cannot join
- Treatment with systemic anticancer therapy within 4 weeks of the first dose of study drug (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.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Spain4 sites
Vall d'Hebron Institute of Oncology
Barcelona, 08035
University Hospital Foundation Jimenez Diaz
Madrid, 28040
University Hospital HM Sanchinarro
Madrid, 28050
Hospital Clinic Universitario Biomedical Research institute INCLIVA
Valencia, 46010
Germany3 sites
University Duisburg-Essen, University Hospital Essen
Essen, 45147
Nordwest Hospital GmbH
Frankfurt am Main, Hesse, 60488
University Hospital Hamburg-Eppendorf
Hamburg, 20246
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, 13620
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea St. Vincent's Hospital
Suwon
United States2 sites
Dana Faber Cancer Institute
Boston, Massachusetts, 02215
University of Southern California
Los Angeles, California, 90033
United Kingdom1 site
Institute of Cancer Research - Royal Marsden
London
About this study
Official title: A Phase 1/2a Open Label, Multicenter Study to Access the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients With Advanced Solid Tumors
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.
Read the detailed description
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
- Conditions
- Advanced Solid Tumor
- Being tested
- 14 mg AFM24, 40 mg AFM24, 80 mg AFM24, 160 mg AFM24, 320 mg AFM24
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 mg AFM24Drug
14 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
40 mg AFM24Drug
40 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
80 mg AFM24Drug
80 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
160 mg AFM24Drug
160 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
320 mg AFM24Drug
320 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
480 mg AFM24Drug
480 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
720 mg AFM24Drug
720 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1- 14 mg Cohort 1 | Experimental | Subjects, with tumors known to express EGFR, who received 14 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. Receives: Drug: 14 mg AFM24 |
| Phase 1- 40 mg Cohort 2 | Experimental | Subjects, with tumors known to express EGFR, who received 40 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. Receives: Drug: 40 mg AFM24 |
| Phase 1- 80 mg Cohort 3 | Experimental | Subjects, with tumors known to express EGFR, who received 80 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. Receives: Drug: 80 mg AFM24 |
| Phase 1- 160 mg Cohort 4 | Experimental | Subjects, with tumors known to express EGFR, who received 160 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. Receives: Drug: 160 mg AFM24 |
| Phase 1- 320 mg Cohort 5 | Experimental | Subjects, with tumors known to express EGFR, who received 320 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. Receives: Drug: 320 mg AFM24 |
| Phase 1- 480 mg Cohort 6 | Experimental | Subjects, with tumors known to express EGFR, who received 480 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. Receives: Drug: 480 mg AFM24 |
| Phase 1- 720 mg Cohort 7 | Experimental | Subjects, with tumors known to express EGFR, who received 720 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). Receives: Drug: 720 mg AFM24 |
| Phase 2- CRC 480 mg Cohort A | Experimental | Subjects with microsatellite stable (MSS) colorectal cancer (CRC) with rat sarcoma gene (RAS) wild-type tumor expressing EGFR who received 480 milligram (mg) AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). Receives: Drug: 480 mg AFM24 |
| Phase 2- ccRCC 480 mg Cohort B | Experimental | Subjects with clear cell renal cell carcinoma (ccRCC) expressing EGFR who received 480 milligram (mg) AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). Receives: Drug: 480 mg AFM24 |
| Phase 2- NSCLC 480 mg Cohort C | Experimental | Subjects with advanced or metastatic (non-small cell lung cancer) NSCLC with an epidermal growth factor receptor (EGFR) mutation who received 480 milligram (mg) AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). Receives: Drug: 480 mg AFM24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: The Number of Subjects With Dose Limiting Toxicities (DLTs) During Cycle 1
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).
Measured: During Cycle 1 (up to 28 days)
Phase 2a: Overall Response Rate (Complete Response [CR] + Partial Response [PR])
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.
Measured: Up to approximately 16 weeks.
Secondary outcomes (21)
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Adverse Events (AEs) will be summarized with patient counts by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs) and Preferred Terms (PTs).
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 1: The Number of Subjects With Serious Adverse Events (SAEs)
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).
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 1: Area Under the Concentration-time Curve From Time 0 to Time Tau (7 Days) of AFM24 in Plasma
Area under the concentration-time curve from time 0 to time tau (7 days) of AFM24 in plasma (AUC0-168)
Measured: 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.
Phase 1: Maximum Plasma Concentration (Cmax) of AFM24
Maximum measured concentration (Cmax) of AFM24 in plasma
Measured: 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.
Phase 1: Time of Maximum Observed Concentration (Tmax) of AFM24
First time to maximum observed concentration of AFM24 sampled during a dosing interval.
Measured: 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.
Phase 1: Minimum Plasma Concentration (Cmin) of AFM24
Minimum measured concentration (Cmin) of AFM24 in plasma
Measured: 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.
Phase 1: The Number of Subjects Who Developed Anti-drug Antibodies (ADAs) and Neutralizing ADAs During Treatment With AFM24
The number of subjects who developed anti-drug antibodies (ADAs) at any time during the study.
Measured: Pre-dose cycle 1 Day 1 and end of treatment, up to approximately 39 weeks.
Phase 1: Overall Response Rate (Complete Response (CR) + Partial Response (PR))
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.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 1: Duration of Response Rate (DOR)
The DOR defined as time from first assessment of partial response (PR) or complete response (CR) to follow-on first assessment of progressive disease will be summarized by descriptive statistics including median DOR and where appropriate the respective 95% confidence intervals (CIs).
Measured: through study completion (estimated up to 24 weeks)
Phase 1: Disease Control Rate (Complete Response (CR) + Partial Response (PR) +Stable Disease (SD))
Disease control as defined by achieving CR and/or PR and/or SD assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 2a: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Adverse Events (AEs) will be summarized with patient counts by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Classes (SOCs) and Preferred Terms (PTs).
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: The Number of Subjects With Serious Adverse Events (SAEs)
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).
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Trough Concentration (Ctrough) of AFM24
Trough concentration (Ctrough) of AFM24 in plasma.
Measured: Pre-dose (2 hours maximum) on Cycle 1 Day 22.
Phase 2a: Maximum Plasma Concentration (Cmax) of AFM24
Maximum measured concentration (Cmax) of AFM24 in plasma.
Measured: Pre-dose (2 hours maximum) on Cycle 1 Day 22 and at end of infusion (EOI) on Cycle 1 Day 22.
Phase 2a: The Number of Subjects Who Developed Anti-drug Antibodies (ADAs) During Treatment With AFM24
The number of subjects who developed anti-drug antibodies (ADAs) at any time during the study.
Measured: Pre-dose cycle 1 Day 1 and end of treatment, up to approximately 101 weeks.
Phase 2a: Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Assessed by Central RECIST v1.1
Overall response as defined by achieving confirmed CR and/or PR assessed by Central 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.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Duration of Response Rate (DOR) by RECIST v1.1 by Local Review
The DOR defined as time from first assessment of partial response (PR) or complete response (CR) to follow-on first assessment of progressive disease will be summarized by descriptive statistics including median DOR and where appropriate the respective 95% confidence intervals (CIs). Assessments by local reader used only.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Duration of Response Rate (DOR) by RECIST v1.1 by Central Review
The DOR defined as time from first assessment of partial response (PR) or complete response (CR) to follow-on first assessment of progressive disease will be summarized by descriptive statistics including median DOR and where appropriate the respective 95% confidence intervals (CIs). Assessment by central reader used only.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Disease Control Rate (Complete Response (CR) + Partial Response (PR) +Stable Disease (SD))
Disease control as defined by achieving CR and/or PR and/or SD assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease control was assessed by local RECIST v1.1 and by central RECIST v1.1.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Progression-free-survival (PFS)
Progression-Free Survival (PFS) was defined as (date of first progression - date of first study drug injection)/30.4375. PFS was measured by local and central assessments.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Overall Survival
Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation.
Measured: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start7 Apr 2020
- Primary completion12 Jul 2023
- Study completion24 Jun 2024
Why it stopped: Enrollment into expansion cohorts in Phase 2 part was terminated due to sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affimed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Emig, MD, Study director, Affimed GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259450
- Sponsor's protocol ID
- AFM24-101
- Status last verified
- Jun 2025
- First submitted
- 3 Feb 2020
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Open Label, Multicenter Study to Access the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AFM24 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04259450
- Acronym / sponsor ID
- AFM24-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment into expansion cohorts in Phase 2 part was terminated due to sponsor decision
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Affimed GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase 1- 14 mg Cohort 1 | Experimental | Drug: 14 mg AFM24Subjects, with tumors known to express EGFR, who received 14 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. |
| Phase 1- 40 mg Cohort 2 | Experimental | Drug: 40 mg AFM24Subjects, with tumors known to express EGFR, who received 40 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. |
| Phase 1- 80 mg Cohort 3 | Experimental | Drug: 80 mg AFM24Subjects, with tumors known to express EGFR, who received 80 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. |
| Phase 1- 160 mg Cohort 4 | Experimental | Drug: 160 mg AFM24Subjects, with tumors known to express EGFR, who received 160 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. |
| Phase 1- 320 mg Cohort 5 | Experimental | Drug: 320 mg AFM24Subjects, with tumors known to express EGFR, who received 320 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. |
| Phase 1- 480 mg Cohort 6 | Experimental | Drug: 480 mg AFM24Subjects, with tumors known to express EGFR, who received 480 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. |
| Phase 1- 720 mg Cohort 7 | Experimental | Drug: 720 mg AFM24Subjects, with tumors known to express EGFR, who received 720 milligram (mg) AFM24 on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). |
| Phase 2- CRC 480 mg Cohort A | Experimental | Drug: 480 mg AFM24Subjects with microsatellite stable (MSS) colorectal cancer (CRC) with rat sarcoma gene (RAS) wild-type tumor expressing EGFR who received 480 milligram (mg) AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). |
| Phase 2- ccRCC 480 mg Cohort B | Experimental | Drug: 480 mg AFM24Subjects with clear cell renal cell carcinoma (ccRCC) expressing EGFR who received 480 milligram (mg) AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). |
| Phase 2- NSCLC 480 mg Cohort C | Experimental | Drug: 480 mg AFM24Subjects with advanced or metastatic (non-small cell lung cancer) NSCLC with an epidermal growth factor receptor (EGFR) mutation who received 480 milligram (mg) AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. A dose could be given over two days (split day dosing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adequate organ function
- Phase 1: Histologically or cytologically confirmed advanced or metastatic solid malignancies that are known to express EGFR
- Phase 1: Previously treated with ≥ 1 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.
- Phase 1: Patients must have at least one tumor site that is accessible to biopsy
- Phase 2a: Measurable disease per RECIST 1.1
Key exclusion criteria (4 listed)
- Treatment with systemic anticancer therapy within 4 weeks of the first dose of study drug (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14 mg AFM2414 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 14 mg Cohort 1 |
| 40 mg AFM2440 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 40 mg Cohort 2 |
| 80 mg AFM2480 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 80 mg Cohort 3 |
| 160 mg AFM24160 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 160 mg Cohort 4 |
| 320 mg AFM24320 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 320 mg Cohort 5 |
| 480 mg AFM24480 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 480 mg Cohort 6, Phase 2- CRC 480 mg Cohort A, Phase 2- NSCLC 480 mg Cohort C, Phase 2- ccRCC 480 mg Cohort B |
| 720 mg AFM24720 milligram AFM24 weekly on Day 1, Day 8, Day 15, and Day 22 of a 28-day cycle. | Drug | Phase 1- 720 mg Cohort 7 |
Primary outcome
Phase 1: The Number of Subjects With Dose Limiting Toxicities (DLTs) During Cycle 1
Time frame: 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).
Phase 2a: Overall Response Rate (Complete Response [CR] + Partial Response [PR])
Time frame: 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.
21 secondary outcomes
Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 1: The Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 1: Area Under the Concentration-time Curve From Time 0 to Time Tau (7 Days) of AFM24 in Plasma
Time frame: 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.
Phase 1: Maximum Plasma Concentration (Cmax) of AFM24
Time frame: 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.
Phase 1: Time of Maximum Observed Concentration (Tmax) of AFM24
Time frame: 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.
Phase 1: Minimum Plasma Concentration (Cmin) of AFM24
Time frame: 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.
Phase 1: The Number of Subjects Who Developed Anti-drug Antibodies (ADAs) and Neutralizing ADAs During Treatment With AFM24
Time frame: Pre-dose cycle 1 Day 1 and end of treatment, up to approximately 39 weeks.
Phase 1: Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 1: Duration of Response Rate (DOR)
Time frame: through study completion (estimated up to 24 weeks)
Phase 1: Disease Control Rate (Complete Response (CR) + Partial Response (PR) +Stable Disease (SD))
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 43 weeks.
Phase 2a: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: The Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Trough Concentration (Ctrough) of AFM24
Time frame: Pre-dose (2 hours maximum) on Cycle 1 Day 22.
Phase 2a: Maximum Plasma Concentration (Cmax) of AFM24
Time frame: Pre-dose (2 hours maximum) on Cycle 1 Day 22 and at end of infusion (EOI) on Cycle 1 Day 22.
Phase 2a: The Number of Subjects Who Developed Anti-drug Antibodies (ADAs) During Treatment With AFM24
Time frame: Pre-dose cycle 1 Day 1 and end of treatment, up to approximately 101 weeks.
Phase 2a: Overall Response Rate (Complete Response [CR] + Partial Response [PR]) Assessed by Central RECIST v1.1
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Duration of Response Rate (DOR) by RECIST v1.1 by Local Review
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Duration of Response Rate (DOR) by RECIST v1.1 by Central Review
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Disease Control Rate (Complete Response (CR) + Partial Response (PR) +Stable Disease (SD))
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Progression-free-survival (PFS)
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Phase 2a: Overall Survival
Time frame: From the start of first infusion till the last infusion + 30 days, up to approximately 105 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Emig, MD study director
Affimed GmbH
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 14 mg AFM24, 40 mg AFM24 and 80 mg AFM24 in people with Advanced Solid Tumor, run by Affimed GmbH at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain, Germany, South Korea, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: The Number of Subjects With Dose Limiting Toxicities (DLTs) During Cycle 1 (time frame: During Cycle 1 (up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.