Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Infections

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Stomach Neoplasms

Esophageal Neoplasms

Urinary Bladder Neoplasms

Melanoma

Carcinoma, Renal Cell

Carcinoma, Merkel Cell

Neoplasms, Second Primary

Neoplastic Processes

Stomach Cancer

Esophageal Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Merkel Cell Carcinoma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Aldesleukin

Immunomodulating Agents

Immunoglobulins

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

AU-007 (Q2w) will be administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort

AU-007 (Q2w) will be administered at a fixed dose in combination with a single dose of aldesleukin with the initial AU-007 dose. The aldesleukin dose will be escalated with each Dose Escalation Cohort

AU-007 will be administered at a fixed dose in combination with a aldesleukin, both administered Q2w. The aldesleukin dose will be escalated with each Dose Escalation Cohort

AU-007

John Powderly, MD

Meredith McKean

George Blumenschein

Drew Rasco

Siwen Hu-Lieskovan

Paul DeSouza

Elizabeth Ahern

Andrew Weickhardt

Andrew Haydon, MD

Catherine Oakman

James Vasselli, MD

This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w)

This is a first in human, multicenter, open-label Phase 1-2 study evaluating the safety, tolerability, and initial efficacy of AU-007 with or without aldesleukin, in patients with unresectable locally advanced or metastatic cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Phase 1 consists of 3 escalation Arms, each starting with a single 1+2 escalation cohort followed by 3+3 escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD). The study begins in Arm A evaluating escalating doses of AU-007 (Q2w) in sequential escalation cohorts to define the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Arm B, AU-007 (Q2w) is evaluated in combination with a single dose of aldesleukin given with the first AU-007 dose. AU-007 is administered at a fixed dose (Q2w) with an escalating single aldesleukin dose in sequential escalation cohorts. In Arm C, AU-007 is evaluated in combination with aldesleukin both given Q2w. AU-007 will be administered at a fixed dose with an escalating dose of aldesleukin in each sequential Arm C escalation cohort. The Phase 2, cohort expansion portion of the study consists of three expansion Arms evaluating the initial efficacy of the RP2D from corresponding dose escalation Arms A, B, and C in selected solid tumor types. Initially, melanoma and renal cell cancer will be evaluated in each Arm. Other eligible cancers include but not limited to Merkel Cell Carcinoma, non-small cell lung cancer and urothelial cancer.

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

Measured by the frequency of DLTs (Dose limiting Toxicity) and safety profile

With AU-007 alone or in combination with aldesleukin measured by PK, PD, and Biomarkers

The AUC of AU-007 will be measured at different timepoints after AU-007 administration

The Cmax of AU-007 will be measured at different timepoints after AU-007 administration

The Tmax of AU-007 will be measured at different timepoints after AU-007 administration

The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration

Assessed by summarizing the number of patients who develop detectable anti-drug antibodies (ADAs) at different timepoints after AU-007 alone or in combination with aldesleukin

Clinical anti-tumor activity will be evaluated using conventional Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST v1.1.

Aulos Bioscience, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Uterine Cervical Neoplasms

Breast Neoplasms

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Squamous Cell Carcinoma of Head and Neck

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Stomach Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Pembrolizumab

Carboplatin

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

sigvotatug vedotin + pembrolizumab +/- (carboplatin)

Administered into the vein (IV; intravenously)

sigvotatug vedotin

200mg every 3 weeks or 400mg every 6 weeks, given by IV

pembrolizumab

cisplatin

AUC 5 mg/mL per min every 3 weeks, given by IV

carboplatin

Seagen Trial Information Support

Ingrid Acker

Cesar Perez Batista, MD

Alisa Posner

Bruno Bockorny, MD

Illya Dixon

Kartik Sehgal

Edwin C Kingsley

Megan Boland

Afshin Dowlati

Providence Cancer Institute CT.Gov Contact

Rachel E Sanborn

Staci Vogel

Steven Powell

Rabia Khan

Sarina A Piha-Paul

Isabel Jimenez

Amita Patnaik

Yiqun (Lydia) Xue

Joseph Z Ye

Antoine Hollebecque

Tatiana Carolina Hernandez Guerrero

Elena Garralda Cabanas

Alvaro Rodriguez Lescure

Jesus Corral

Federico Longo

Emiliano Calvo

Fernando Rivera Herrero

Solange Peters

Elisa Fontana

Juanita Lopez

Medical Monitor

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors.

The study will have four parts.

* Part A of the study will find out how much sigvotatug vedotin should be given to participants.
* Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors.
* Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs.
* Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors.
* In Parts C and D, participants will receive sigvotatug vedotin with either:

  * Pembrolizumab or,
  * Pembrolizumab and carboplatin, or
  * Pembrolizumab and cisplatin.

A Study of SGN-B6A in Advanced Solid Tumors

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

The proportion of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to RECIST v1.1.

The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or to death due to any cause

The time from the start of any study treatment to the first documentation of PD, or death due to any cause

The time from the start of any study treatment to the date of death due to any cause

Seagen Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer	NCT05267626	Advanced Solid ... Metastatic Canc...	AU-007 Aldesleukin	18 Years -	Aulos Bioscience, Inc.
A Study of SGN-B6A in Advanced Solid Tumors	NCT04389632	Carcinoma, Non-... Squamous Cell C... HER2 Negative B... Esophageal Squa... Esophageal Aden... Gastroesophagea... Ovarian Neoplas... Cutaneous Squam... Exocrine Pancre... Urinary Bladder... Uterine Cervica... Stomach Neoplas...	sigvotatug vedo... pembrolizumab cisplatin carboplatin	18 Years -	Seagen Inc.

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