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Study to Assess AFM24 in Advanced Solid Cancers

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ClinicalTrials.gov Identifier: NCT04259450
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Affimed GmbH

Brief 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.

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 4 arms based on tumor type of metastatic colorectal cancer and non-small cell lung cancer.

AFM24 is a tetravalent bispecific (anti-human EGFR x anti-human CD16A) innate immune cell engaging recombinant antibody construct 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-positive cancer cells.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: AFM24 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : March 1, 2023

Arm Intervention/treatment
Experimental: AFM24

Phase 1: Treatment of escalating doses of AFM24.

Phase 2a: Treatment of AFM24 at maximum tolerated dose/recommended phase 2 dose, stratified into cohorts by tumor type.

Drug: AFM24
Weekly intravenous infusions




Primary Outcome Measures :
  1. Phase 1: Incidence of dose limiting toxicities (DLTs) during Cycle 1 [ Time Frame: During Cycle 1 (each cycle is 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

  2. Phase 2a: Overall Response Rate (complete response [CR] + partial response [PR]) [ Time Frame: through study completion (estimated up to 24 weeks) ]
    Assessed by: Local RECIST v1.1


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Minimum plasma concentration (Cmin)

  3. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Area under the concentration-time curve (AUCss(0-t))

  4. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Clearance (CL)

  5. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Volume of Distribution (Vd) volume of Distribution at Steady state (Vss), terminal t1/2

  6. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Volume of Distribution at Steady state (Vss) terminal t1/2

  7. Pharmacokinetics (PK) of AFM24 [ Time Frame: During Cycle 1 (each cycle is 28 days) ]
    Terminal half-life (t1/2)

  8. Incidence of patients who develop anti-drug antibodies (ADAs) and neutralizing ADAs during treatment with AFM24 [ Time Frame: through study completion (estimated up to 24 weeks) ]
    Measurement of ADAs before and throughout treatment with AFM24

  9. Overall Response Rate (complete response [CR] + partial response [PR]) [ Time Frame: through study completion (estimated up to 24 weeks) ]
    Assessed by: Local RECIST v1.1

  10. Duration of Response Rate (DOR) [ Time Frame: through study completion (estmated up to 24 weeks) ]
    Assessed by: Local RECIST v1.1

  11. Disease Control rate (CR + PR +stable disease [SD]) [ Time Frame: through study completion (Estimated up to 24 weeks) ]
    Assessed by: Local RECIST v1.1

  12. Phase 2a: Number of patients with drug-related Adverse Events (AEs) grade 3 or worse) [ Time Frame: through study completion (Estimated up to 24 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced or metastatic solid malignancies that are known to express EGFR, or in which EGFR is thought to be a relevant therapeutic target, including but not limiting to: colorectal, lung, gastric, esophageal, pancreatic, head and neck, breast, ovarian, cervical, urothelial, and renal cancers, and Glioblastoma multiforme.
  • Previously treated with one or more 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.
  • Adequate organ function
  • Patients must have at least one tumor site that is accessible to biopsy
  • Phase 2a only: Measurable disease per RECIST v1.1

Exclusion Criteria:

  • Treatment with systemic anticancer therapy within 4 weeks (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04259450


Contacts
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Contact: Christa Raab + 49 6221 6743 ext 694 c.raab@affimed.com
Contact: Sylvia Schwarz, PhD + 49 6221 6743 ext 620 s.schwarz@affimed.com

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Lorraine Martinez         
United States, Massachusetts
Dana Faber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mark Awad, MD         
Principal Investigator: Mark Awad, MD         
Spain
Vall d'Hebron Institute of Oncology Recruiting
Barcelona, Spain, 08035
Contact: Elena Garralda, MD         
United Kingdom
Institute of Cancer Research - Royal Marsden Recruiting
London, United Kingdom
Contact: Patricia Garcia         
Sponsors and Collaborators
Affimed GmbH
Investigators
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Study Director: Andras Strassz, MD Affimed GmbH
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Responsible Party: Affimed GmbH
ClinicalTrials.gov Identifier: NCT04259450    
Other Study ID Numbers: AFM24-101
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No