AFM24 + Atezolizumab for Advanced Cancer

Recruiting at 16 trial locations

Overseen By Affimed GmbH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Affimed GmbH

Must not be taking: Anticancer, Investigational, Mitomycin, others

Disqualifiers: Active malignancy, Radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing AFM24 with atezolizumab in patients with advanced cancers that have not responded to other treatments. The treatment works by helping the immune system recognize and attack cancer cells. Atezolizumab is used in various advanced cancers, including lung and breast cancer.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anticancer therapy, including investigational agents, at least 4 weeks before starting the study drug. If you are using certain drugs like mitomycin C or nitrosoureas, the period is 6 weeks, and for fluorouracil or small molecule targeted drugs, it's 2 weeks or 5 half-lives, whichever is longer.

Is the combination of AFM24 and Atezolizumab safe for humans?

Atezolizumab, also known as Tecentriq, has been used in various cancer treatments and generally has an acceptable safety profile. Common side effects include fatigue, decreased appetite, and nausea, while more serious effects can include lung inflammation and liver issues. The safety of AFM24 in combination with Atezolizumab specifically may not be fully established, but Atezolizumab alone has been considered safe in multiple studies. ^{1 2 3 4 5}

How is the AFM24 + Atezolizumab drug unique for advanced cancer?

The combination of AFM24 and Atezolizumab is unique because it combines a novel treatment (AFM24) with Atezolizumab, a drug that blocks PD-L1, a protein that helps cancer cells evade the immune system. This combination aims to enhance the immune system's ability to fight cancer, offering a potentially new approach for patients with advanced cancer. ^{2 3 6 7 8}

What data supports the effectiveness of the drug Atezolizumab in combination with AFM24 for advanced cancer?

Atezolizumab has shown effectiveness in treating various cancers, such as bladder cancer and non-small cell lung cancer, by improving survival rates and response rates in patients. It works by blocking a protein that helps cancer cells hide from the immune system, allowing the body to better fight the cancer. ^{2 3 5 7 8}

Who Is on the Research Team?

Daniela Morales-Espinosa, MD

Principal Investigator

Affimed GmbH

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic EGFR-positive cancers, like NSCLC, gastric/GEJ adenocarcinoma, HCC, hepatobiliary-, or pancreatic cancer that's worsened after treatment. They must have had certain prior therapies and good organ function. People can't join if they've had recent radiation therapy, active malignancies (with some exceptions), recent anticancer treatments, are using traditional Chinese medicine for tumors, or are in another clinical study.

Inclusion Criteria

I have advanced liver, bile duct, or pancreatic cancer and have tried at least one standard treatment.

My organs are working well.

Phase 1: Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria

I have no active cancers except for certain treated or non-threatening types.

I haven't had radiation therapy in the last 2 weeks or still have side effects from it.

I haven't taken any cancer drugs or traditional Chinese medicine for cancer in the last 2 to 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

Participants receive a single dose of AFM24 and are observed for adverse events for 1 week

1 week

Dose Escalation

Determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AFM24 in combination with atezolizumab using a 3+3 design

Estimated up to 36 weeks

Expansion

Collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab

Estimated up to 36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AFM24
• Atezolizumab

Trial Overview The AFM24-102 study tests the combination of a new drug called AFM24 with an existing cancer medication Atezolizumab in patients with specific advanced solid tumors expressing EGFR. It's an open-label Phase 1/2a trial where all participants receive the drugs to evaluate safety and effectiveness at different doses.

How Is the Trial Designed?

Group I: Expansion Phase Experimental Treatment 2 Interventions

The expansion phase will collect preliminary evidence of efficacy and further confirm the safety of AFM24 in combination with atezolizumab.

Group II: Escalation Phase Experimental Treatment 2 Interventions

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.

AFM24 is already approved in United States for the following indications:

Approved in United States as AFM24 for:

• Advanced and/or metastatic EGFR-expressing non-small cell lung cancer (NSCLC)

Who Is Running the Clinical Trial?

Affimed GmbH

Lead Sponsor

Trials

11

Recruited

650+

Published Research Related to This Trial

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab, combined with nab-paclitaxel, significantly improved progression-free survival in patients with advanced triple-negative breast cancer (TNBC) compared to placebo, based on the phase III IMpassion130 trial involving patients with unresectable locally advanced or metastatic TNBC.

While the combination therapy showed a tolerable safety profile, with common side effects like neutropenia and immune-related adverse events, it did not significantly affect health-related quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer. Kang, C., Syed, YY.[2020]

Atezolizumab combined with chemotherapy (ABCP or ACnP) has been shown to significantly improve progression-free survival (PFS) and overall survival (OS) in chemotherapy-naïve patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), based on the IMpower150 and IMpower130 studies.

Both treatment regimens (ABCP and ACnP) demonstrated manageable safety profiles, with most immune-related side effects being mild to moderate and reversible, making them promising first-line options for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. Dhillon, S., Syed, YY.[2020]

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab, the first anti-PD-L1 monoclonal antibody approved by the FDA, has shown promising efficacy in treating metastatic triple-negative breast cancer, supported by data from the Phase III IMpassion130 trial.

The review highlights the pharmacodynamic and pharmacokinetic properties of atezolizumab, emphasizing its safety and effectiveness in various cancers, including small-cell lung cancer and renal cell cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. Mavratzas, A., Seitz, J., Smetanay, K., et al.[2020]

Atezolizumab, a PD-L1 blocking antibody, shows higher rates of objective response, progression-free survival, and overall survival when used as a first-line therapy in chemotherapy-naïve patients with metastatic non-small cell lung cancer (NSCLC), compared to its use in later treatment lines.

The review included 15 ongoing studies, with 5 reporting results, indicating that atezolizumab is being explored in various treatment combinations and settings, suggesting its potential as a versatile first-line treatment option for NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. Ryu, R., Ward, KE.[2023]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer. [2020]

5. France pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Atezolizumab for the First-Line Treatment of Non-small Cell Lung Cancer (NSCLC): Current Status and Future Prospects. [2023]