Advanced Solid TumorPhase 1/2NCT05109442
Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers
A Phase 1/2 study testing AFM24 and Atezolizumab 840 MG in 14 ML Injection in people with Advanced Solid Tumor, run by Affimed GmbH at 16 sites in 5 countries.
Trial summary
AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing 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?
- AFM24 and Atezolizumab 840 MG in 14 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 19 Nov 2021to 11 Jun 2025
- 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
- Histologically or cytologically confirmed advanced or metastatic EGFR-positive selected cancer types (except for NSCLC)
- Advanced or metastatic NSCLC, EGFR WT: disease has progressed after ≥ 1 prior lines of therapy which must have included a platinum-based doublet in combination with PD1/PD-L1 antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet
- Advanced, unresectable, or metastatic gastric/GEJ adenocarinoma: after ≥ 1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet
- Advanced or metastatic HCC (BCLC C or B not amenable or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma: after ≥1 prior line of an approved SOC therapy for the respective disease type or to whom the available SOC is not appropriate in the opinion of the investigator
- Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥ prior TKI approved for EGFR mutated NSCLC. Subjects treated with a 1st or 2nd generation TKI in 1st line who developed a documented T790M mutation must have received a TKI targeting this mutation such as Osimertinib or Lazertinib to be eligible. Subjects must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulation free tumor DNA. The patients should have received a 2nd line of treatment if approved and available or may be enrolled in the study if in the opinion of the investigator it is in the patient's best interest,or the SOC is not appropriate.
- Adequate organ function
- Phase 1: Evaluable or measurable disease per RECIST v1.1
- Phase 2a: Measurable disease per RECIST v1.1
Who cannot join
- Treatment with systemic anticancer therapy including investigational agent within 4 weeks of the first dose of study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indication.
- 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 active in any other clinical study, or administration of other investigational agent
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Poland5 sites
Independent Public Teaching Hospital #4 in Lublin, Department of Clinical Oncology and Chemotherapy
Lublin, 20-954
European Health Center Otwock Fryderyk Chopin Hospital, Department of Clinical Oncology
Otwock, 05-400
MED-Polonia, Sp. z o.o. (LLC)
Poznan, 60-693
Janusz Korczak Provincial Specialist Hospital in Slupsk Limited Liability Company
Słupsk, 76-200
Maria Sklodowska-Curie - National Research Institute of Oncology, Early Phase Research Department
Warsaw, 02-781
Spain4 sites
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, 08035
University Hospital Quiron Madrid
Madrid, 28223
University Clinic of Navarra - Pamplona
Pamplona, 31008
Hospital Clinic Universitario Biomedical Research institute INCLIVA
Valencia, 46010
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Chicago Medical Center
Chicago, Illinois, 60637
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, 13620
Severance Hospital, Yonsei University Health System
Seoul, 03722
The Catholic University of Korea St. Vincent's Hospital
Suwon, 93
United Kingdom1 site
Royal Marsden NHS Foundation Trust - ICR
Sutton, SM2 5PT
About this study
Official title: A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination With Atezolizumab in Patients With Selected Advanced/Metastatic EGFR-expressing Cancers
AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
Read the detailed description
There will be 2 parts in this study: a dose escalation phase (phase 1) and an expansion phase (phase 2a). Patients will qualify to receive the investigational drugs (AFM24 + atezolizumab) in the dose escalation phase or the expansion phase only if they are deemed eligible following the safety lead-in phase. Seven days before the planned first combination treatment, patients will receive a single dose of AFM24 and will be observed for any adverse events for 1 week.
The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab.
The dose escalation phase will be followed by the expansion phase once the MTD/RP2D of AFM24 in combination with atezolizumab has been determined. The expansion phase of the study is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 in combination with atezolizumab.
The tumor types planned to be studied in the AFM24/atezolizumab combination study will be:
- Non-small cell lung cancer (EGFR-WT), with disease progression after chemotherapy and PD1/PD-L1 targeted therapy
- Gastric/GEJ cancer if intolerant to or with disease progression after standard platinum-based chemotherapy
- Pancreatic/hepatocellular/biliary tract cancer with disease progression after standard of care (SOC) therapy or if there is no appropriate SOC available for their condition
- Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation with disease progression on or after received ≥1 prior lines of treatment for advanced disease, including a Tyrosine-Kinase Inhibitor (TKI) for EGFR mutations
- Conditions
- Advanced Solid Tumor
- Being tested
- AFM24, Atezolizumab 840 MG in 14 ML Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFM24Drug
intravenous infusion
Atezolizumab 840 MG in 14 ML InjectionDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Escalation Phase | Experimental | The Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D. Receives: Drug: AFM24; Drug: Atezolizumab 840 MG in 14 ML Injection |
| Expansion Phase | Experimental | The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab. Receives: Drug: AFM24; Drug: Atezolizumab 840 MG in 14 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Incidence of 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 Technology Criteria for Adverse Events (CTCAE) v5.0
Measured: During cycle 1 (each cycle has 28 days)
Phase 2a: Overall Response Rate (Complete Response [CR] or Partial Response [PR])
Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later.
Measured: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.
Secondary outcomes (12)
Incidence of Patients With TEAEs
Number of patients with treatment-emergent adverse events (TEAEs) non-serious or serious
Measured: From first drug administration up to 30 (non-serious TEAEs) or 56 (serious TEAEs) days after last dose AFM24, until start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approx. 35 (phase 1) and 105 weeks (phase 2a).
Incidence of Patients With SAEs
Number of patients with treatment-emergent serious adverse events (serious TEAEs)
Measured: From first drug administration up to 56 days after the last dose of AFM24, until the start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approximately 35 (phase 1) and 105 weeks (phase 2a).
Pharmacokinetics (PK) of AFM24
Maximum plasma concentration (Cmax) on Cycle 1 Day 22
Measured: During cycle 1 (each cycle has 28 days)
Pharmacokinetics (PK) of AFM24
Minimum plasma concentration (Cmin) Corresponding to Ctrough levels at the end of the dosing interval at Cycle 1 Day 22
Measured: During cycle 1 (each cycle has 28 days)
Pharmacokinetics (PK) of AFM24
Area under the concentration-time curve over the dose interval (AUCtau) on Cycle 1 Day 22
Measured: During cycle 1 (each cycle has 28 days)
Pharmacokinetics (PK) of AFM24
Time to Cmax (Tmax) on Cycle 1 Day 22
Measured: During cycle 1 (each cycle has 28 days)
Frequency of Patients Developing Anti-drug Antibodies (ADAs) Against AFM24
Measurement of ADAs before and during treatment with AFM24 in combination with atezolizumab Patients with at least one ADA-positive result at baseline or post-baseline counted as developing anti-drug antibodies (ADAs) against AFM24
Measured: Ph 1 within 2h prior to: each drug intake (Cycle 1), 1st + 3rd drug intake (Cycle 2 onwards) and at EOT, up to 27 weeks. Ph 2a within 2h prior to: 1st drug intake (Cycle 1 and Cycle 3 onwards), 1st + 3rd drug intake (Cycle 2) and at EOT, up to 97 weeks.
Phase 1: Overall Response Rate (Complete Response [CR] or Partial Response [PR])
Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later.
Measured: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 27 weeks.
Phase 2a: Progression-free Survival
Progression-Free Survival (PFS) was defined as (date of first progression - date of first study drug injection)/30.4375. Patients without progression or death were censored. Tumor assessment by RECIST v1.1 by investigator.
Measured: From the first treatment received until the first progression disease assessed by investigator or death.
Phase 2a: Duration of Response
Duration of Response (DOR) was defined as (date of first progression or death - date of first response (unconfirmed))/30.4375. Patients without response were excluded from the analysis. Patients without progression or death were censored. Tumor assessment by RECIST v1.1 by investigator.
Measured: From the date of first response (unconfirmed) until progression disease assessed by investigator or death.
Phase 2a: Clinical Benefit Rate (CR or PR [Any Duration] or Stable Disease Equal or > 24 Weeks)
Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Clinical benefit rate (CR or PR or SD ≥24 weeks). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. Best overall response is SD if SD or unconfirmed CR or unconfirmed PR at least 42 days after C1D1. Best overall response SD counts for Clinical benefit rate if SD ongoing for at least 24 weeks.
Measured: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.
Phase 2a: Disease Control Rate (DCR) (Complete Response [CR] or Partial Response [PR] or Stable Disease [SD])
Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Disease Control Rate (CR or PR or SD). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later. Best overall response is SD if SD or unconfirmed CR or unconfirmed PR at least 42 days after C1D1.
Measured: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start19 Nov 2021
- Primary completion6 Mar 2025
- Study completion11 Jun 2025
Why it stopped: The trial was prematurely discontinued due to the financial situation of the sponsor and not for safety or efficacy reasons.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affimed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniela Morales-Espinosa, MD, Study director, Affimed GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109442
- Sponsor's protocol ID
- AFM24-102
- Status last verified
- Aug 2025
- First submitted
- 1 Oct 2021
- Last updated
- 20 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 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 Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination With Atezolizumab in Patients With Selected Advanced/Metastatic EGFR-expressing Cancers
- ClinicalTrials.gov ID
- NCT05109442
- Acronym / sponsor ID
- AFM24-102
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was prematurely discontinued due to the financial situation of the sponsor and not for safety or efficacy reasons.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Affimed GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Posted 20 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AFM24-102 is a Phase 1/2a open-label, non-randomized, multicenter, dose escalation, and expansion study evaluating AFM24 in combination with atezolizumab in patients with selected EGRF-expressing advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.
Detailed description
There will be 2 parts in this study: a dose escalation phase (phase 1) and an expansion phase (phase 2a). Patients will qualify to receive the investigational drugs (AFM24 + atezolizumab) in the dose escalation phase or the expansion phase only if they are deemed eligible following the safety lead-in phase. Seven days before the planned first combination treatment, patients will receive a single dose of AFM24 and will be observed for any adverse events for 1 week.
The aim of the dose escalation phase is to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab.
The dose escalation phase will be followed by the expansion phase once the MTD/RP2D of AFM24 in combination with atezolizumab has been determined. The expansion phase of the study is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24 in combination with atezolizumab.
The tumor types planned to be studied in the AFM24/atezolizumab combination study will be:
- Non-small cell lung cancer (EGFR-WT), with disease progression after chemotherapy and PD1/PD-L1 targeted therapy
- Gastric/GEJ cancer if intolerant to or with disease progression after standard platinum-based chemotherapy
- Pancreatic/hepatocellular/biliary tract cancer with disease progression after standard of care (SOC) therapy or if there is no appropriate SOC available for their condition
- Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation with disease progression on or after received ≥1 prior lines of treatment for advanced disease, including a Tyrosine-Kinase Inhibitor (TKI) for EGFR mutations
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escalation Phase | Experimental | Drug: AFM24, Drug: Atezolizumab 840 MG in 14 ML InjectionThe Escalation phase will determine the MTD/RP2D of AFM24 in combination with atezolizumab. A traditional 3+3 design will be used to determine the RP2D. |
| Expansion Phase | Experimental | Drug: AFM24, Drug: Atezolizumab 840 MG in 14 ML InjectionThe expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed advanced or metastatic EGFR-positive selected cancer types (except for NSCLC)
- Advanced or metastatic NSCLC, EGFR WT: disease has progressed after ≥ 1 prior lines of therapy which must have included a platinum-based doublet in combination with PD1/PD-L1 antibody or must have received an anti-PD1/PD-L1 antibody prior to or after a platinum-based doublet
- Advanced, unresectable, or metastatic gastric/GEJ adenocarinoma: after ≥ 1 prior chemotherapy regimen including a platinum and fluoropyrimidine doublet
- Advanced or metastatic HCC (BCLC C or B not amenable or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma: after ≥1 prior line of an approved SOC therapy for the respective disease type or to whom the available SOC is not appropriate in the opinion of the investigator
- Advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received ≥ prior TKI approved for EGFR mutated NSCLC. Subjects treated with a 1st or 2nd generation TKI in 1st line who developed a documented T790M mutation must have received a TKI targeting this mutation such as Osimertinib or Lazertinib to be eligible. Subjects must have documentation of EGFR mutated NSCLC as assessed by an approved test using genomic sequencing of tumor or circulation free tumor DNA. The patients should have received a 2nd line of treatment if approved and available or may be enrolled in the study if in the opinion of the investigator it is in the patient's best interest,or the SOC is not appropriate.
Key exclusion criteria (4 listed)
- Treatment with systemic anticancer therapy including investigational agent within 4 weeks of the first dose of study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indication.
- 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 active in any other clinical study, or administration of other investigational agent
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 |
|---|---|---|
| AFM24intravenous infusion | Drug | Escalation Phase, Expansion Phase |
| Atezolizumab 840 MG in 14 ML Injectionintravenous infusion | Drug | Escalation Phase, Expansion Phase |
Primary outcome
Phase 1: Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1
Time frame: During cycle 1 (each cycle has 28 days)
The number of patients with dose limiting toxicities (DLTs) in the first cycle, as assessed by the National Cancer Institute Common Technology Criteria for Adverse Events (CTCAE) v5.0
Phase 2a: Overall Response Rate (Complete Response [CR] or Partial Response [PR])
Time frame: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.
Tumor assessment by RECIST v1.1 by investigator. Best overall response was used to define the Overall Response Rate (CR or PR). Best overall response is CR or PR if a CR or PR assessed at least 42 days after Cycle 1 Day 1 was confirmed by subsequent tumor assessment at least 4 weeks later.
12 secondary outcomes
Incidence of Patients With TEAEs
Time frame: From first drug administration up to 30 (non-serious TEAEs) or 56 (serious TEAEs) days after last dose AFM24, until start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approx. 35 (phase 1) and 105 weeks (phase 2a).
Incidence of Patients With SAEs
Time frame: From first drug administration up to 56 days after the last dose of AFM24, until the start of a subsequent anticancer treatment, or data cut-off date, whichever is sooner. Up to approximately 35 (phase 1) and 105 weeks (phase 2a).
Pharmacokinetics (PK) of AFM24
Time frame: During cycle 1 (each cycle has 28 days)
Pharmacokinetics (PK) of AFM24
Time frame: During cycle 1 (each cycle has 28 days)
Pharmacokinetics (PK) of AFM24
Time frame: During cycle 1 (each cycle has 28 days)
Pharmacokinetics (PK) of AFM24
Time frame: During cycle 1 (each cycle has 28 days)
Frequency of Patients Developing Anti-drug Antibodies (ADAs) Against AFM24
Time frame: Ph 1 within 2h prior to: each drug intake (Cycle 1), 1st + 3rd drug intake (Cycle 2 onwards) and at EOT, up to 27 weeks. Ph 2a within 2h prior to: 1st drug intake (Cycle 1 and Cycle 3 onwards), 1st + 3rd drug intake (Cycle 2) and at EOT, up to 97 weeks.
Phase 1: Overall Response Rate (Complete Response [CR] or Partial Response [PR])
Time frame: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 27 weeks.
Phase 2a: Progression-free Survival
Time frame: From the first treatment received until the first progression disease assessed by investigator or death.
Phase 2a: Duration of Response
Time frame: From the date of first response (unconfirmed) until progression disease assessed by investigator or death.
Phase 2a: Clinical Benefit Rate (CR or PR [Any Duration] or Stable Disease Equal or > 24 Weeks)
Time frame: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.
Phase 2a: Disease Control Rate (DCR) (Complete Response [CR] or Partial Response [PR] or Stable Disease [SD])
Time frame: Tumor assessments were conducted during last week of cycle 2, 4, 6, 8, 10, 12 and every 3 cycles thereafter (each cycle has 28 days), up to approximately 97 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
Daniela Morales-Espinosa, MD study director
Affimed GmbH
16 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 AFM24 and Atezolizumab 840 MG in 14 ML Injection in people with Advanced Solid Tumor, run by Affimed GmbH at 16 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 8 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Poland, Spain, United States, South Korea, 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 20 Aug 2025). 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: Incidence of Dose Limiting Toxicities (DLTs) During Cycle 1 (time frame: During cycle 1 (each cycle has 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 20 Aug 2025.