• Follow
  • Follow
  • Follow
  • Follow
U

Search



Shop

w

News

w

Blog

DONATE
Team Jack Foundation
  • About Us
    • Our Mission
    • Jack Hoffman
    • Board & Staff
    • Financials
  • Our Impact
    • Scientific Advisory Board
    • Sponsored Grants
    • Research Articles
  • Brain Cancer
    • What is Brain Cancer?
      • What is DIPG?
    • Brain Cancer Facts
    • Cancer Awareness Months
      • Brain Tumor Awareness Month
    • Family Resources
  • Events
  • Get Involved
    • Fundraise
      • Host an Event
      • Run For Team Jack
      • Birthday Fundraiser
    • Give
    • Our Sponsors
    • Volunteer
  • Heroes
  • Donate
  • Shop
  • Blog
  • News
Select Page

Get Involved

Clinical Trial Finder

Search Results

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Study Purpose

This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.

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:

1. Participant must be 18 years of age or older at the time of signing the informed consent. 2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma ore relapsed refractory metastatic non-small cell lung cancer (NSCLC). 3. Melanoma participant experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody. Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody. Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease). Participant must not have been exposed to both taxane and gemcitabine. 4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation. 5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1. 6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months. 7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE]). 8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery. 9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements. 10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count. 11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.

Exclusion Criteria:

1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ). 2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are up to 1.5cm in diameter that have been treated, if clinically indicated. 3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation. 4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions. 5. Participant has any form of primary or acquired immunodeficiency. 6. Participant has a history of hypersensitivity to any component of the study intervention. 7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions). 8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed. 9. Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent. 10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD). 11. Participant has evidence of positive infectious disease screening and/or any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.

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.

NCT06060613
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/Phase 2
Lead Sponsor

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

Obsidian Therapeutics, Inc.
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
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.

Tumor Skin, Metastatic Melanoma, Melanoma, Lung Cancer, Metastatic Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
Additional Details

Primary Objective (Phase 1): • Assess the safety and tolerability of OBX-115 regimen.Primary Objective (Phase 2): • Evaluate preliminary efficacy of OBX-115 regimen as measured by the investigator using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.Secondary (Phase 1): • Assess preliminary efficacy of OBX-115 regimen by evaluating ORR.Secondary (Phase 2): • Evaluate safety and tolerability of OBX 115 based on the collected AE data.Secondary (both Phase 1 and Phase 2):

  • - Evaluate duration of response (DOR): To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to cancer.
  • - Evaluate disease control rate (DCR): To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) for at least 4 weeks per RECIST v1.1 as assessed by the investigator.
  • - Evaluate progression-free survival (PFS): To evaluate the time from the date of OBX-115 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause.
  • - Evaluate overall survival (OS): To evaluate the time from the date of OBX-115 infusion to death due to any cause.
  • - Evaluate feasibility of the manufacturing process: Evaluated as the proportion of OBX-115 products initiated for manufacturing that pass release criteria for infusion.

Arms & Interventions

Arms

Experimental: Participants with advanced solid tumors

Participants will receive conditioning therapy prior to administration of OBX-115 regimen.

Interventions

Biological: - OBX-115

A tumor sample is obtained from each participant for autologous OBX-115 manufacture. After lymphodepletion including cyclophosphamide and fludarabine, participant will receive OBX-115 infusion, followed by short courses of acetazolamide.

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.

Los Angeles, California

Status

Recruiting

Address

The Angeles Clinic and Research Institute (Melanoma)

Los Angeles, California, 90025

Site Contact

Saba Mukarram

[email protected]

781-202-5423

Los Angeles, California

Status

Recruiting

Address

USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)

Los Angeles, California, 90033

Site Contact

Sandy Tran

[email protected]

323-865-3935

Stanford, California

Status

Recruiting

Address

Stanford Cancer Institute (Melanoma/NSCLC)

Stanford, California, 94305

Site Contact

Claire Billman

[email protected]

6507366425

Orlando, Florida

Status

Recruiting

Address

Orlando Health Cancer Institute (Melanoma/NSCLC)

Orlando, Florida, 32806

Site Contact

Estefania Bobe Cortes

[email protected]

781-202-5423

Louisville, Kentucky

Status

Recruiting

Address

James Graham Brown Cancer Center (Melanoma/NSCLC)

Louisville, Kentucky, 40202

Site Contact

Melissa B. Hall

[email protected]

781-202-5423

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering (Melanoma/NSCLC)

New York, New York, 10065

Site Contact

Melanoma

[email protected]

6464979067

The Ohio State University, Columbus, Ohio

Status

Recruiting

Address

The Ohio State University

Columbus, Ohio, 43210

Site Contact

Miranda Bean

[email protected]

6142934254

Pittsburg, Pennsylvania

Status

Recruiting

Address

Allegheny Research Institute (Melanoma/NSCLC)

Pittsburg, Pennsylvania, 15224

Site Contact

Lindsay Brown

[email protected]

781-202-5423

Houston, Texas

Status

Recruiting

Address

M.D. Anderson Cancer Center (Melanoma/NSCLC)

Houston, Texas, 77030

Site Contact

Steffy Jose

[email protected]

781-202-5423

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
Powered By

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.

Make an impact through your inbox

News, upcoming events and research updates delivered straight to your inbox.

  • This field is for validation purposes and should be left unchanged.
MAKE AN IMPACT

Donate today to help the Team Jack Foundation fund research and fight pediatric brain cancer.

Make a Donation
  • About Us
  • Our Mission
  • Jack Hoffman
  • Board & Staff
  • Fund Allocation
  • Financials
  • Our Impact
  • Scientific Advisory Board
  • Sponsored Grants
  • Research Articles
  • Brain Cancer
  • Family Resources
  • Get Involved
  • Fundraise
  • Give
  • Events
  • Our Sponsors
  • Volunteer
  • Follow
  • Follow
  • Follow
  • Follow
  • Follow
seal of transparency badge - 2019 Gold
combined health agencies drive member charity badge
Share Omaha member badge
© 2021 Team Jack Foundation. PO Box 607, Atkinson, NE, 68713. All Rights Reserved. Team Jack Foundation, Inc. is exempt from federal income tax under section 501(c)3, ID Number 46-2301134, of the internal revenue code. All contributions to the Foundation are tax deductible. Privacy Policy • Contact