Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers

NCT05109442 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: AFM24-102
• Study Type: interventional
• Target: 112
• Locations: 5 countries
• Sites: 16

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  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

  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

  During cycle 1 (each cycle has 28 days)

• Pharmacokinetics (PK) of AFM24

  During cycle 1 (each cycle has 28 days)

• Pharmacokinetics (PK) of AFM24

  During cycle 1 (each cycle has 28 days)

Study Arms (2)

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.

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.

Drug: AFM24; Drug: Atezolizumab 840 MG in 14 ML Injection

Interventions

AFM24 DRUG

intravenous infusion

Escalation Phase; Expansion Phase

Atezolizumab 840 MG in 14 ML Injection DRUG

intravenous infusion

Escalation Phase; Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affimed GmbH: lead

Study Sites (16)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Independent Public Teaching Hospital #4 in Lublin, Department of Clinical Oncology and Chemotherapy

Lublin, 20-954, Poland

Location

European Health Center Otwock Fryderyk Chopin Hospital, Department of Clinical Oncology

Otwock, 05-400, Poland

Location

MED-Polonia, Sp. z o.o. (LLC)

Poznan, 60-693, Poland

Location

Janusz Korczak Provincial Specialist Hospital in Slupsk Limited Liability Company

Słupsk, 76-200, Poland

Location

Maria Sklodowska-Curie - National Research Institute of Oncology, Early Phase Research Department

Warsaw, 02-781, Poland

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Suwon, 93, South Korea

Location

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, 08035, Spain

Location

University Hospital Quiron Madrid

Madrid, 28223, Spain

Location

University Clinic of Navarra - Pamplona

Pamplona, 31008, Spain

Location

Hospital Clinic Universitario Biomedical Research institute INCLIVA

Valencia, 46010, Spain

Location

Royal Marsden NHS Foundation Trust - ICR

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Interventions

atezolizumab; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Limitations and Caveats

The study was terminated early (early termination submitted to FDA on 12 June 2025). The decision to terminate early was solely based on the company's financial situation and not influenced by safety or efficacy data. The primary completion date, i.e when the criteria for the final analysis according to the protocol are met is: 06 March, 2025. The data snapshot used for the reported results is 07 April, 2025 (not fully cleaned). SDVs performed: 99.7% for Phase 1, 97.1% for Phase 2.

Results Point of Contact

• Title: Clinical Operations
• Organization: Affimed GmbH

trials@affimed.com

+49 621 56003-0

Study Officials

• Daniela Morales-Espinosa, MD

  Affimed GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 5, 2021
• Study Start: November 19, 2021
• Primary Completion: March 6, 2025
• Study Completion: June 11, 2025
• Last Updated: August 20, 2025
• Results First Posted: August 20, 2025

Record last verified: 2025-08

Locations

GB (1); US (3); PL (5); KR (3); ES (4)