NCT06060613

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_1

Timeline
38mo left

Started Oct 2023

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2023Jun 2029

First Submitted

Initial submission to the registry

September 22, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

September 22, 2023

Last Update Submit

April 27, 2026

Conditions

Tumor SkinMetastatic MelanomaMelanomaLung CancerNon Small Cell Lung CancerMetastatic Non Small Cell Lung CancerMetastatic Lung Cancer

Keywords

Adoptive cell therapyTumor Infiltrating LymphocytesTILMelanomaLung Cancer

Outcome Measures

Primary Outcomes (3)

  • Incidence and nature of dose-limiting toxicities (DLTs)

    • Incidence of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 infusion (Phase 1).

    28 Days

  • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1

    • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR) 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 Cohort 3)

    2 years

  • The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1

    • 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 Cohort 1, 2, and 4)

    2 years

Secondary Outcomes (2)

  • The proportion of participants who have a confirmed CR or PR per RECIST v1.1

    2 years

  • Incidence of AEs

    2 years

Study Arms (1)

Participants with advanced solid tumors

EXPERIMENTAL

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

Biological: OBX-115

Interventions

OBX-115BIOLOGICAL

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.

Participants with advanced solid tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant must be 18 years of age or older at the time of signing the informed consent.
  • Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).
  • Cohort and indication specific criteria as follows:
  • Phase 1 and Phase 2 Cohort 1 (enrollment complete):
  • Participants with unresectable or metastatic melanoma must have 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.
  • Phase 1 and Phase 2 Cohort 2 (recruiting):
  • 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 any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting.
  • Phase 2 Cohort 3 (recruiting):
  • Participants with unresectable or metastatic melanoma must have 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 targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF/MEK inhibitor that was given as the most recent line of therapy.
  • Phase 2 Cohort 4 (recruiting):
  • Participants with frontline unresectable or metastatic melanoma.
  • +9 more criteria

You may not qualify if:

  • Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).
  • 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 that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.
  • Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.
  • Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.
  • Participant has any form of primary or acquired immunodeficiency.
  • Participant has a history of hypersensitivity to any component of the study intervention.
  • Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).
  • Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.
  • Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.
  • Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Angeles Clinic and Research Institute (Melanoma)

Los Angeles, California, 90025, United States

RECRUITING

USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)

Los Angeles, California, 90033, United States

RECRUITING

Stanford Cancer Institute (Melanoma/NSCLC)

Stanford, California, 94305, United States

RECRUITING

Orlando Health Cancer Institute (Melanoma/NSCLC)

Orlando, Florida, 32806, United States

RECRUITING

James Graham Brown Cancer Center (Melanoma/NSCLC)

Louisville, Kentucky, 40202, United States

RECRUITING

Memorial Sloan Kettering (Melanoma/NSCLC)

New York, New York, 10065, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Allegheny Research Institute (Melanoma/NSCLC)

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Skin NeoplasmsMelanomaLung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Central Study Contacts

Obsidian Therapeutics

CONTACT

781-202-5423OBX115-2301TRIAL@OBSIDIANTX.COM

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

September 29, 2023

Study Start

October 25, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(9)