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Safety and Efficacy of OBX-115 in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06060613
Recruitment Status : Recruiting
First Posted : September 29, 2023
Last Update Posted : February 1, 2024
Sponsor:
Information provided by (Responsible Party):
Obsidian Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Tumor Skin Metastatic Melanoma Melanoma Lung Cancer Metastatic Lung Cancer Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Biological: OBX-115 Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors
Actual Study Start Date : October 25, 2023
Estimated Primary Completion Date : October 30, 2025
Estimated Study Completion Date : October 30, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants with advanced solid tumors
Participants will receive conditioning therapy prior to administration of OBX-115 regimen.
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 a short course of acetazolamide.





Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities (DLTs) [ Time Frame: 28 Days ]
    • Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).

  2. The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 [ Time Frame: 2 years ]
    • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 2)


Secondary Outcome Measures :
  1. The proportion of participants who have a confirmed CR or PR per RECIST v1.1 [ Time Frame: 2 years ]
    • The proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the Investigator from the date of OBX-115 infusion until disease progression, death, start of a new anticancer therapy, withdrawal of consent, or end of study, whichever comes first (Phase 1)

  2. Incidence of AEs [ Time Frame: 2 years ]
    • Incidence of treatment-emergent adverse events (TEAEs), including SAEs, study intervention related AEs, and AEs leading to early discontinuation of study intervention or withdrawal from the Assessment Period or death up to 2 years after initiation of study intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. If the tumor is BRAF V600 mutation-positive, the participant should also have received a BRAF inhibitor with or without a MEK inhibitor. 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).
  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 >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.
  2. Participant has a history of brain metastases or leptomeningeal disease.
  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 unegineered TIL cell therapy is allowed.
  9. Participant requires systemic steroid therapy >10 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06060613


Contacts
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Contact: Obsidian Therapeutics 781-202-5423 OBX115-2301TRIAL@OBSIDIANTX.COM

Locations
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United States, Florida
Orlando Health Cancer Institute (Melanoma) Recruiting
Orlando, Florida, United States, 32806
Contact: Mary Perry       Mary.Perry@orlandohealth.com   
Principal Investigator: Sajeve Thomas, MD         
United States, Kentucky
James Graham Brown Cancer Center (Melanoma/NSCLC) Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa B. Hall       Mmbaro01@louisville.edu   
Principal Investigator: Jason Chesney, MD, PhD         
Sponsors and Collaborators
Obsidian Therapeutics, Inc.
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Responsible Party: Obsidian Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06060613    
Other Study ID Numbers: OBX115-23-01
First Posted: September 29, 2023    Key Record Dates
Last Update Posted: February 1, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Obsidian Therapeutics, Inc.:
Adoptive cell therapy
Tumor Infiltrating Lymphocytes
TIL
Melanoma
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas