AFM24 for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Solid TumorsAFM24 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer treatment that combines a drug called AFM24 with a drug called atezolizumab. The trial is open to people with certain types of advanced cancer who have tried other treatments that didn't work.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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Study Objectives

2 Primary · 7 Secondary · Reporting Duration: During cycle 1 (each cycle has 28 days)

Day 28
Pharmacokinetics (PK) of AFM24
Phase 1: Incidence of dose limiting toxicities (DLTs) during Cycle 1
Week 36
Frequency of patients developing anti-drug antibodies (ADAs) against AFM24
Incidence of TEAEs and SAEs
Phase 1: Overall Response Rate (complete response [CR] + partial response [PR])
Phase 2a: Clinical benefit rate (CR or PR [any duration] or stable disease equal or > 24 weeks)
Phase 2a: Duration of response
Phase 2a: Overall Response Rate (complete response [CR] + partial response [PR])
Phase 2a: Progression-free survival

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
BNT153
1
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1
BAY2416964

Trial Design

2 Treatment Groups

Escalation Phase
1 of 2
Expansion Phase
1 of 2

Experimental Treatment

105 Total Participants · 2 Treatment Groups

Primary Treatment: AFM24 · No Placebo Group · Phase 1 & 2

Escalation PhaseExperimental Group · 2 Interventions: AFM24, Atezolizumab 840 MG in 14 ML Injection · Intervention Types: Drug, Drug
Expansion PhaseExperimental Group · 2 Interventions: AFM24, Atezolizumab 840 MG in 14 ML Injection · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during cycle 1 (each cycle has 28 days)

Who is running the clinical trial?

Affimed GmbHLead Sponsor
8 Previous Clinical Trials
535 Total Patients Enrolled
Daniela Morales-Espinosa, MDStudy DirectorAffimed GmbH

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced, unresectable, or metastatic gastric/GEJ adenocarcinoma.
References

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