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Dermatologic Agents

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Antibodies, Bispecific

Immunoglobulins

Coal Tar

Immunoglobulins, Intravenous

Part 1 Dose Escalation using ALG.APV-527 doses with a starting dose of 0.1 mg/kg and projected 6 dose cohorts will be explored to determine the MTD and/or the RP2D. Part 1 consists of a 3 + 3 dose-escalation examination of ALG.APV-527 single agent therapy in adult patients with RECIST Version1.1-measurable advanced solid tumors.

Part 2 Dose Expansion with ALG.APV-527 based on RP2D determined during Dose Escalation.

ALG.APV-527 is a human bispecific antibody in the ADAPTIR™ format with a silenced immunoglobulin 1 (IgG1) Fc domain targeting the co-stimulatory receptor 4-1BB, expressed on immune cells such as CD8+ T cells and natural killer (NK) cells, and the tumor associated antigen 5T4. ALG.APV-527 is being co-developed by Alligator Bioscience AB (Lund, Sweden) and Aptevo Therapeutics Inc. (Seattle, WA, USA) as a cancer immunotherapy.

ALG.APV-527

Caroline Taromino, MBA

Christine Gerdes

A first-in-human, multicenter, open-label, dose escalation and dose expansion phase 1 study in patients with advanced solid tumors to evaluate the safety of intravenously administered ALG.APV-527 (Short title: ALG.APV-527 first-in-human study). Adult patients with advanced/metastatic solid tumors likely to express 5T4 antigen who have failed standard of care regimens for their cancer, have become refractory to standard treatment, or for whom no effective therapy exists based on investigator judgment may be enrolled in this study.

Part 1 (Dose Escalation): Approximately 36 evaluable patients planned to be enrolled.

Part 2 (Dose Expansion): Approximately 20 evaluable patients planned to be enrolled.

This first-in-human study is an open-label, multicenter, Phase 1 study with the aim to assess safety and tolerability and preliminary anti-tumor activity of ALG.APV-527 administered intravenously to patients with advanced solid tumor malignancies. Patients will be required to provide tumor tissue biopsy material that has been obtained within 28 days prior to the first dose of study drug ALG.APV-527.

The trial has 2 parts, Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The Escalation Phase (Part 1) is projected to occur in 6 patient cohorts of increasing dose levels and will explore the Maximum Tolerated Dose (MTD) and/or the RP2D. Part 1 consists of a 3 + 3 dose-escalation examination of ALG.APV-527 single agent therapy in adult patients with RECIST Version1.1-measurable advanced solid tumors.

The MTD is defined as the highest dose level that has 6 patients evaluable for DLT with no more than 1 of 6 with DLT.

Part 2 (Dose Expansion):

Part 2 consists of a single agent evaluation of the safety and clinical activity of ALG.APV-527 at its RP2D in up to 20 patients with advanced solid tumors. Part 2 will commence after all tested dose levels have been reviewed and a RP2D has been determined.

Primary Objectives:

Primary (Dose Escalation)

* To determine the safety, tolerability, MTD of ALG.APV-527 administered intravenously as single agent therapy
* To designate an IV dose level for the Dose Expansion Phase (RP2D) of ALG.APV-527 administered IV as single agent therapy for patients with advanced solid tumors. The RP2D can be different from the MTD.

Primary (Dose Expansion)

• To further evaluate the safety and tolerability of ALG.APV-527 when administered intravenously at the RP2D level as monotherapy in patients with advanced solid tumors

Escalating ALG.APV-527 doses with a starting dose of 0.1 mg/kg and projected 6 dose cohorts will be explored to determine the MTD and/or the RP2D. Part 1 consists of a 3 + 3 dose-escalation examination of ALG.APV-527 single agent therapy in adult patients with RECIST Version1.1-measurable advanced solid tumors. Part 2 consists of Dose Expansion using the RP2D, as determined during Dose Escalation.

ALG.APV-527 First-in-human Study

A First-in-human, Multicenter, Open-label, Dose Escalation and Dose Expansion Phase 1 Study in Patients With Advanced Solid Tumors to Evaluate the Safety of Intravenously Administered ALG.APV-527

Number of participants with DLTs during the 28 days following the first administration of Q2W ALG.APV 527 or during the 42 days following Q3W ALG.APV 527

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence based on the response evaluation criteria in solid tumors (RECIST), v1.1

Pharmacokinetic samples will be collected at predefined timepoints to determine Cmax.

Pharmacokinetic samples will be collected at predefined timepoints to determine AUC.

Alligator Bioscience AB

Aptevo Therapeutics

SYD1875 IV (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.

SYD1875

Ellen Mommers, PhD

This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.

Cancer cells can have different kinds of proteins on their cell surface; one of these is the oncofetal antigen 5T4. 5T4 plays an important role in the development of cancer. Currently no drugs are available that work via the 5T4 antigen.

The new cancer drug SYD1875 is being developed by Byondis B.V. SYD1875 is an antibody-drug conjugate and consists of two parts: an antibody and a linker-drug moiety containing a toxin. The antibody part binds to 5T4 on the surface of the cancer cell. When SYD1875 binds to this cancer cell, it will be internalized by the cell. After proteolytic cleavage of the linker, the toxin will be split off in the cell and the cancer cell will be killed. Thus, SYD1875 can be considered as a form of targeted chemotherapy.

This is the first study in which SYD1875 is administered to humans. The study consists of two parts:

Part 1 is the dose-escalation part in which a low dose of SYD1875 is given to cancer patients. If it is well tolerated, a higher dose of SYD1875 will be given to other cancer patients until the maximum tolerated dose is reached.

In Part 2 of the study, groups of patients with a specific type of cancer will receive the SYD1875 dose which has been selected for further evaluation.

All patients from both parts of the study will receive SYD1875 infusions every three weeks until progression of the cancer or unacceptable toxicity develops.

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With 5T4-expressing Locally Advanced or Metastatic Solid Tumours

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ALG.APV-527 First-in-human Study	NCT05934539	Solid Tumor	ALG.APV-527	18 Years -	Aptevo Therapeutics
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875	NCT04202705	Solid Tumor	SYD1875	18 Years -	Byondis B.V.
ALG.APV-527 First-in-human Study	NCT05934539	Solid Tumor	ALG.APV-527	18 Years -	Aptevo Therapeutics

Spots Global Cancer Trial Database for 5t4

Every month we try and update this database with for 5t4 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 5t4

Every month we try and update this database with for 5t4 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 5t4 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.