History of Changes for Study: NCT04259450

Study to Assess AFM24 in Advanced Solid Cancers

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Study Record Versions

Version	Submitted Date	Changes
1	February 5, 2020	None (earliest Version on record)
2	February 19, 2020	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	April 16, 2020	Study Status
4	May 25, 2020	Study Status and Contacts/Locations
5	July 10, 2020	Study Status and Contacts/Locations
6	September 22, 2021	Outcome Measures, Study Status, Study Description, Contacts/Locations, Eligibility, Arms and Interventions and Study Design
7	January 19, 2022	Contacts/Locations and Study Status
8	March 2, 2022	Contacts/Locations and Study Status
9	March 31, 2022	Contacts/Locations and Study Status
10	April 14, 2022	Study Status and Contacts/Locations
11	May 10, 2022	Contacts/Locations and Study Status
12	July 7, 2022	Contacts/Locations and Study Status
13	September 30, 2022	Study Status and Contacts/Locations
14	October 5, 2022	Study Status
15	December 5, 2022	Contacts/Locations and Study Status
16	August 22, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	AFM24-101
Brief Title:	Study to Assess AFM24 in Advanced Solid Cancers
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
Secondary IDs:

Study Status


Record Verification:	February 2020
Overall Status:	Not yet recruiting
Study Start:	February 1, 2020
Primary Completion:	April 1, 2022 [Anticipated]
Study Completion:	March 1, 2023 [Anticipated]

First Submitted:	February 3, 2020
First Submitted that Met QC Criteria:	February 5, 2020
First Posted:	February 6, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	February 5, 2020
Last Update Posted:	February 6, 2020 [Actual]

Sponsor/Collaborators


Sponsor:	Affimed GmbH
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

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.

Detailed Description:

Conditions


Conditions:	Advanced Solid Tumor
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1/Phase 2
Interventional Study Model:	Single Group Assignment
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	70 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


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) ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
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.

Contacts/Locations


Central Contact Person:	Christa Raab Telephone: + 49 6221 6743 Ext. 694 Email: c.raab@affimed.com
Central Contact Backup:	Sylvia Schwarz, PhD Telephone: + 49 6221 6743 Ext. 620 Email: s.schwarz@affimed.com
Study Officials:	Andras Strassz, MD Study Director Affimed GmbH
Locations:	United States, California
	University of Southern California Los Angeles, California, United States, 90033 Contact:Contact: Lorraine Martinez

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