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Clinical Trial Finder

Search Results

A Study Evaluating AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Solid Tumors

Study Purpose

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age ≥18 years of age at the time consent is signed.
  • - Has adequate end organ function per laboratory testing.
  • - Pregnancy prevention requirements.
  • - Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology.
  • - Has a performance status of 0 or 1 on Eastern Cooperative Oncology Group scale.
  • - Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts.

Exclusion Criteria:

  • - Has a diagnosis of immunodeficiency.
  • - Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years.
  • - Has known active CNS metastases and/or carcinomatous meningitis.
  • - Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • - Has an active infection requiring systemic therapy.
  • - Inability to comply with study and follow-up procedures.
  • - Has had a severe hypersensitivity reaction (Grade ≥3) to treatment with pembrolizumab, another monoclonal antibody, or has history of any hypersensitivity to any components of the study treatments or any of their excipients.
  • - Has received prior systemic anticancer therapy including investigational agents within 4 weeks (or, if shorter, within 5 half-lives for kinase inhibitors) prior to first dose of study treatment.
  • - Has received prior radiotherapy within 2 weeks of start of study treatment or has had a history of radiation pneumonitis.
  • - Receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
  • - Has received previous treatment with another agent targeting the IL-2, IL-7, or IL-15 receptors.
- Is expected to require any other form of antineoplastic therapy while on study

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05653882
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Asher Biotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Monitor
Principal Investigator Affiliation Asher Biotherapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumor, Non Small Cell Lung Cancer, Melanoma, Squamous Cell Carcinoma of Head and Neck, Renal Cell Carcinoma
Arms & Interventions

Arms

Experimental: etakafusp alfa (AB248) Monotherapy Dose-Escalation

etakafusp alfa (AB248) will be administered intravenously as a single agent

Experimental: etakafusp alfa (AB248) + pembrolizumab Combination Dose-Escalation

etakafusp alfa (AB248) and pembrolizumab will be administered intravenously

Experimental: etakafusp alfa (AB248) Monotherapy Indication Expansion

etakafusp alfa (AB248) will be administered intravenously as a single agent in disease specific cohorts

Experimental: etakafusp alfa (AB248) + pembrolizumab Combination Indication Expansion

etakafusp alfa (AB248) and pembrolizumab will be administered intravenously in disease specific cohorts

Interventions

Biological: - etakafusp alfa (AB248)

Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug

Biological: - pembrolizumab

Intravenous infusion of pembrolizumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte 5344147, California 5332921

Status

Recruiting

Address

City of Hope

Duarte 5344147, California 5332921, 91010

Site Contact

Shama Hussain

[email protected]

626-218-2943

UCLA, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

UCLA

Los Angeles 5368361, California 5332921, 90095

Site Contact

Youstina Zaki

[email protected]

650-410-7588

UCSD, San Diego 5391811, California 5332921

Status

Recruiting

Address

UCSD

San Diego 5391811, California 5332921, 92037

Site Contact

Catherine O'Neil

[email protected]

650-410-7588

UCSF, San Francisco 5391959, California 5332921

Status

Recruiting

Address

UCSF

San Francisco 5391959, California 5332921, 94143

Site Contact

Narimane Badawi

[email protected]

650-410-7588

Yale, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale

New Haven 4839366, Connecticut 4831725, 06510

Site Contact

[email protected]

203-848-8875

University of Miami, Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami

Miami 4164138, Florida 4155751, 33136

Site Contact

[email protected]

650-410-7588

Ocala Oncology Center, Ocala 4166673, Florida 4155751

Status

Recruiting

Address

Ocala Oncology Center

Ocala 4166673, Florida 4155751, 34474

Site Contact

[email protected]

352-732-4938

University of Chicago Medical Center, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

University of Chicago Medical Center

Chicago 4887398, Illinois 4896861, 60637

Site Contact

[email protected]

650-410-7588

Massachusetts General Hospital, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Massachusetts General Hospital

Boston 4930956, Massachusetts 6254926, 02114

Site Contact

Kamaneh Montazeri, MD

[email protected]

617-724-4000

Dana Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

[email protected]

650-410-7588

Karmanos Cancer Institute, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Karmanos Cancer Institute

Detroit 4990729, Michigan 5001836, 48201

Site Contact

Vanessa Galici

[email protected]

313-576-9816

Washington University, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University

St Louis 4407066, Missouri 4398678, 63110

Site Contact

[email protected]

314-747-1171

Rutgers, New Brunswick 5101717, New Jersey 5101760

Status

Recruiting

Address

Rutgers

New Brunswick 5101717, New Jersey 5101760, 08901

Site Contact

Mohammad Ghalib Ghalib, MBBS

[email protected]

732-609-2510

NYU, New York 5128581, New York 5128638

Status

Recruiting

Address

NYU

New York 5128581, New York 5128638, 10016

Site Contact

#[email protected]

650-410-7588

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Site Contact

Monica Chen, MD

[email protected]

650-410-7588

Chapel Hill 4460162, North Carolina 4482348

Status

Recruiting

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill 4460162, North Carolina 4482348, 27599

Site Contact

Doug Whelan

[email protected]

919-843-5060

Providence Cancer Institute Franz Clinic, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Providence Cancer Institute Franz Clinic

Portland 5746545, Oregon 5744337, 97213

Site Contact

Rachel Sanborn, MD

[email protected]

503-215-5396

Sarah Cannon Research Institute, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville 4644585, Tennessee 4662168, 37203

Site Contact

[email protected]

650-410-7588

Intermountain Health, Murray 5778755, Utah 5549030

Status

Not yet recruiting

Address

Intermountain Health

Murray 5778755, Utah 5549030, 84107

Site Contact

Joshua Kunz

[email protected]

801-408-4712

Virginia Commonwealth, Richmond 4781708, Virginia 6254928

Status

Recruiting

Address

Virginia Commonwealth

Richmond 4781708, Virginia 6254928, 23298

Site Contact

Phase I Study Team

[email protected]

804-628-7978

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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