RecruitingPhase 1/2

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

United States208 participantsStarted 2023-10-25

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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):
✓. Phase 1 and Phase 2 Cohort 2 (recruiting):
✓. Phase 2 Cohort 3 (recruiting):
✓. Phase 2 Cohort 4 (recruiting):
✓. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.

✕. 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.

Incidence and nature of dose-limiting toxicities (DLTs)

Timeframe: 28 Days

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

Timeframe: 2 years

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

Timeframe: 2 years

NCT IDNCT06060613

SponsorObsidian Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-30

Obsidian Therapeutics

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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):
✓. Phase 1 and Phase 2 Cohort 2 (recruiting):
✓. Phase 2 Cohort 3 (recruiting):
✓. Phase 2 Cohort 4 (recruiting):
✓. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.

✕. 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.

What they're measuring

Incidence and nature of dose-limiting toxicities (DLTs)

Timeframe: 28 Days

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

Timeframe: 2 years

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

Timeframe: 2 years