Safety and Efficacy of OBX-115 in Advanced Solid Tumors

Launched by OBSIDIAN THERAPEUTICS, INC. · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called OBX-115 for adults with advanced solid tumors, such as metastatic melanoma and non-small cell lung cancer. The main goal of the trial is to see how safe and effective this treatment is for people whose cancer has either come back or has not responded well to previous therapies. The trial is currently looking for participants who are at least 18 years old and have specific types of cancer that have progressed after certain treatments.

To be eligible for the trial, participants should have a confirmed diagnosis of advanced melanoma or non-small cell lung cancer and must have experienced disease progression after receiving prior treatments. They should also have at least one measurable tumor that can be targeted for this new treatment. Throughout the study, participants will receive careful monitoring and support from the research team. It's important to note that there are some health conditions that may prevent someone from participating, so discussing individual circumstances with a healthcare provider is essential.

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Eligibility 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.