RecruitingPhase 1/2

Safety and Efficacy of OBX-115 in Advanced Solid Tumors

United States, Australia208 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Trial details

NCT IDNCT06060613

SponsorObsidian Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-30

Contact for this trial

Obsidian Therapeutics

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

View on ClinicalTrials.gov More Tumor Skin trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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.

Exclusion criteria

. 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.

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